{ "meta": { "total_records": 2046, "timestamp": "2026-06-02T18:18:18Z" }, "data": [ { "title": "Website outages and upgrades", "summary": "The European Medicines Agency (EMA) makes upgrades to this website from time to time, to improve user experience. During these upgrades, the website is unavailable for a short period of time, outside of EMA working hours. This page lists when we are planning the next outage and the main improvements made.", "categories": "Corporate", "first_published_date": "15/06/2021", "last_updated_date": "02/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/website-outages-upgrades" }, { "title": "Languages on this website", "summary": "The European Medicines Agency (EMA) makes its most important information on medicines and on its work available in all official European Union (EU) languages on this website.", "categories": "Corporate", "first_published_date": "17/02/2023", "last_updated_date": "02/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/languages-website" }, { "title": "Frequently asked questions", "summary": "The European Medicines Agency (EMA) answers frequently asked questions (FAQs) about its work and scope.", "categories": "Corporate", "first_published_date": "12/05/2011", "last_updated_date": "02/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/frequently-asked-questions" }, { "title": "Combination Products Operational Group: agendas and highlight reports", "summary": "On this page you can find the agendas and highlight reports of the Combination Products Operational Group (COMBO).", "categories": "Human", "first_published_date": "04/11/2025", "last_updated_date": "01/06/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/combination-products-operational-group/combination-products-operational-group-agendas-highlight-reports" }, { "title": "Enpr-EMA priority activities", "summary": "", "categories": "Human", "first_published_date": "25/07/2019", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema/enpr-ema-priority-activities" }, { "title": "Emergency Task Force (ETF) recommendations", "summary": "The European Medicines Agency's (EMA) Emergency Task Force (ETF) makes available a list of scientific recommendations on the use of medicines.", "categories": "Human", "first_published_date": "19/07/2024", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/emergency-task-force-etf/emergency-task-force-etf-recommendations" }, { "title": "Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/07/2021", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/need-maximum-residue-limit-mrl-evaluation-biological-substances-scientific-guideline" }, { "title": "Expert panel support for breakthrough medical devices: pilot programme", "summary": "The European Medicines Agency (EMA)'s pilot programme on breakthrough medical devices (BtX) is designed to establish a long-term process for manufacturers and notified bodies to request support from the medical device expert panels.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme" }, { "title": "Scientific advice for high-risk medical devices", "summary": "Guidance for manufacturers on requesting clinical advice from the European Medicines Agency (EMA) through expert panels for high-risk medical devices.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/high-risk-medical-devices/scientific-advice-high-risk-medical-devices" }, { "title": "Development of new medicinal products for the treatment of smoking - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2008", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/development-new-medicinal-products-treatment-smoking-scientific-guideline" }, { "title": "VICH GL61 Pharmaceutical Development - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/04/2024", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines/quality-guidelines-non-immunologicals/vich-gl61-pharmaceutical-development-scientific-guideline" }, { "title": "Quality of medicines: questions and answers - Part 2", "summary": "These questions and answers address a number of questions on matters related to the quality of medicines.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "29/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-medicines-questions-answers-introduction/quality-medicines-questions-answers-part-2" }, { "title": "Biologics Working Party Plasma Master File Quality Operational Expert Group (PMF OEG)", "summary": "The Biologics Working Party (BWP) Plasma Master File Quality Operational Expert Group (PMF OEG) is an operational expert group set up to support the BWP coordinators’ role in Plasma master file (PMF) certification as well as to provide support in matters related to the quality aspects of human blood and plasma.", "categories": "Human;Corporate", "first_published_date": "10/04/2025", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/biologics-working-party-plasma-master-file-quality-operational-expert-group-pmf-oeg" }, { "title": "Data protection and privacy at EMA", "summary": "The European Medicines Agency (EMA) collects and handles personal data in various situations. The documents on this page describe why and how EMA does this and what users can do to object.", "categories": "Corporate", "first_published_date": "26/01/2012", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/data-protection-privacy-ema" }, { "title": "SME Regulation and reports", "summary": "The main objective of the small and medium-sized enterprises (SME) Regulation (Commission Regulation (EC) No 2049/2005) is to provide financial and administrative assistance to these enterprises through the SME office of the European Medicines Agency (EMA). It also aims to address the needs of smaller companies in the pharmaceutical sector.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/support-smes/sme-regulation-reports" }, { "title": "Clinical pharmacology and pharmacokinetics: questions and answers", "summary": "The questions and answers (Q&As) on this page provide an overview of the European Medicines Agency's (EMA) position on specific issues related to clinical pharmacology and pharmacokinetics.", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics-guidelines/clinical-pharmacology-pharmacokinetics-questions-answers" }, { "title": "Podcast: Inside EMA", "summary": "Discover the science and the people behind medicines regulation", "categories": "Human;Veterinary", "first_published_date": "18/11/2025", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/news-events/podcast-inside-ema" }, { "title": "Real-world evidence", "summary": "Making greater use of real-world evidence and real-world data can improve the evidence base for benefit-risk decisions. This can help bring medicines to patients.", "categories": "Human;Veterinary", "first_published_date": "24/07/2024", "last_updated_date": "28/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence" }, { "title": "Accelerating Clinical Trials in the EU (ACT EU)", "summary": "The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to develop the European Union further as a competitive centre for innovative clinical research. The European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) run the ACT EU initiative together.", "categories": "Human", "first_published_date": "22/11/2022", "last_updated_date": "27/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/accelerating-clinical-trials-eu-act-eu" }, { "title": "List of medicines under additional monitoring", "summary": "The list of medicines under additional monitoring includes medicines authorised in the European Union (EU) that are being monitored particularly closely by regulatory authorities. Medicines under additional monitoring have a black inverted triangle displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means.", "categories": "Human", "first_published_date": "25/04/2013", "last_updated_date": "27/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/list-medicines-under-additional-monitoring" }, { "title": "One Health approach", "summary": "The European Medicines Agency (EMA) and four other health and environment agencies of the European Union (EU) work together to implement the One Health approach. It aims to enable the EU and its Member States to better prevent, predict, detect and respond to health threats.", "categories": "Human;Veterinary", "first_published_date": "30/01/2025", "last_updated_date": "26/05/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/one-health-approach" }, { "title": "Scientific and technical recommendations: Veterinary Medicines Regulation", "summary": "The European Medicines Agency (EMA) is preparing scientific and technical recommendations to feed into delegated and implementing acts as part of the implementation of the Veterinary Medicines Regulation (Regulation (EU) 2019/6). EMA is providing these recommendations at the request of the European Commission.", "categories": "Veterinary", "first_published_date": "23/09/2019", "last_updated_date": "22/05/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/scientific-technical-recommendations-veterinary-medicines-regulation" }, { "title": "Hantavirus", "summary": "The European Medicines Agency (EMA) is monitoring the May 2026 hantavirus outbreak linked to a cruise ship. This in line with EMA's crisis preparedness and management responsibilities.", "categories": "Human", "first_published_date": "22/05/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/hantavirus" }, { "title": "Data Analysis and Real World Interrogation Network (DARWIN EU)", "summary": "The Data Analysis and Real World Interrogation Network (DARWIN EU®) provides timely and reliable evidence on the use, safety and effectiveness of medicines for human use.", "categories": "Human", "first_published_date": "04/06/2021", "last_updated_date": "20/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence/data-analysis-real-world-interrogation-network-darwin-eu" }, { "title": "Clinical trials in human medicines", "summary": "The European Medicines Agency (EMA) relies on the results of clinical trials that pharmaceutical companies carry out. This helps EMA reach its opinions on the authorisation of medicines. Although clinical trials are authorised at national level in the European Union (EU), EMA plays a key role in further developing the EU as a competitive centre for innovative clinical trials. EMA also supports maintaining IT systems for the coordination of clinical trials.", "categories": "Human", "first_published_date": "19/12/2014", "last_updated_date": "20/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines" }, { "title": "Product-specific bioequivalence guidance", "summary": "This section includes the European Medicines Agency's (EMA) product-specific bioequivalence guidance, which summarises in a standardised format the relevant study design principles for demonstration of bioequivalence.", "categories": "Human", "first_published_date": "05/11/2014", "last_updated_date": "19/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics-guidelines/product-specific-bioequivalence-guidance" }, { "title": "Executive Steering Group on Shortages of Medical Devices", "summary": "The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages of Medical Devices is to ensure a robust response to supply issues with medical devices caused by public health emergencies. It puts in place measures to prevent and correct medical device shortages within the European Union (EU). ", "categories": "Human", "first_published_date": "28/09/2023", "last_updated_date": "19/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/executive-steering-group-shortages-medical-devices" }, { "title": "Ebola", "summary": "The European Medicines Agency (EMA) contributes to the global response to Ebola outbreaks by supporting the development and approval of vaccines and treatments for Ebola.", "categories": "Human", "first_published_date": "24/10/2014", "last_updated_date": "18/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/ebola" }, { "title": "Development and manufacture of synthetic peptides - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "20/09/2022", "last_updated_date": "12/05/2026", "general_url": "https://www.ema.europa.eu/en/development-manufacture-synthetic-peptides-scientific-guideline" }, { "title": "Parallel scientific advice and special development aspects or product types", "summary": "The European Medicines Agency (EMA) carries out scientific advice in cooperation with other decision-making bodies in the European Union (EU) and beyond. Some of these processes have distinct purposes and refer to specific product types. For instance, EMA can participate in parallel joint scientific consultations with the Member State Coordination Group on HTA (HTACG). EMA also provides scientific advice for biosimilar medicines and for human medicines required in public health emergencies, among others.", "categories": "Human", "first_published_date": "04/07/2017", "last_updated_date": "12/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/parallel-scientific-advice-special-development-aspects-or-product-types" }, { "title": "Other fees and charges for medicinal products for human use, veterinary medicinal products and consultations on medical devices", "summary": "Guidance in a question-and-answer format on the European Medicines Agency’s fees for inspections, transfers, pre-submission requests, re-examinations, certificates, parallel distribution notices, other scientific services, and medical devicess, in line with Regulation (EU) 2024/568 (the New Fee Regulation)", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/04/2025", "last_updated_date": "12/05/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/other-fees-charges-medicinal-products-human-use-veterinary-medicinal-products-consultations-medical-devices" }, { "title": "PRIME: priority medicines", "summary": "PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines targeting unmet medical needs. It is based on early dialogue with companies to optimise development plans and speed up evaluation.", "categories": "Human", "first_published_date": "26/10/2015", "last_updated_date": "08/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines" }, { "title": "Revamp of marketing authorisation assessment templates", "summary": "The European Medicines Agency (EMA) has been revising its assessment report templates and reviewing how they are completed to reduce duplication and improve efficiency.", "categories": "Human;Corporate", "first_published_date": "08/05/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/assessment-templates-guidance/revamp-marketing-authorisation-assessment-templates" }, { "title": "PRAC recommendations on safety signals", "summary": "Each month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines.", "categories": "Human", "first_published_date": "04/10/2013", "last_updated_date": "04/05/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals" }, { "title": "Liraglutide 6 mg/mL solution for injection in a prefilled pen product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/liraglutide-6-mg-ml-solution-injection-prefilled-pen-product-specific-bioequivalence-guidance" }, { "title": "Tafamidis soft gelatin capsules 20 mg and 61 mg product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/tafamidis-soft-gelatin-capsules-20-mg-61-mg-product-specific-bioequivalence-guidance" }, { "title": "Hybrid approach biological guidelines", "summary": "The European Medicines Agency's scientific guidelines on the hybrid approach for veterinary medicines help applicants to prepare marketing authorisation applications under Article 19. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements set in Regulation (EU) 2019/6.", "categories": "Veterinary", "first_published_date": "30/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/hybrid-approach-biological-guidelines" }, { "title": "Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions", "summary": "The European Medicines Agency (EMA) publishes the opinions of medical device expert panels on Class III implantable devices and Class IIb devices intended to administer or remove medicinal products.", "categories": "", "first_published_date": "17/10/2024", "last_updated_date": "29/04/2026", "general_url": "https://www.ema.europa.eu/en/class-iii-implantable-devices-class-iib-medical-devices-intended-administer-or-remove-medicinal-products-expert-panel-opinions" }, { "title": "VICH GL18(R2) impurities: residual solvents in new veterinary medicinal products, active substances and excipients - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/09/2011", "last_updated_date": "29/04/2026", "general_url": "https://www.ema.europa.eu/en/vich-gl18r2-impurities-residual-solvents-new-veterinary-medicinal-products-active-substances-excipients-scientific-guideline" }, { "title": "ICH Q3C (R9) Residual solvents - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2011", "last_updated_date": "29/04/2026", "general_url": "https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline" }, { "title": "Advisory group on vaccine confidence", "summary": "The European Medicines Agency's (EMA) advisory group on vaccine confidence advises EMA on vaccine hesitancy and helps increase science outreach in this area.", "categories": "", "first_published_date": "29/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/advisory-group-vaccine-confidence" }, { "title": "Plasma master file certificates", "summary": "Following the positive evaluation of a plasma master file (PMF) under the PMF certification scheme, the European Medicines Agency (EMA) issues a certificate of compliance with European legislation which is valid throughout the European Union. EMA publishes the list of all the issued PMF certificates.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "28/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificates" }, { "title": "Demonstration of biosimilarity of biological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/demonstration-biosimilarity-biological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union - Scientific guideline", "summary": "Development of resistance and impact on public and animal health", "categories": "Veterinary", "first_published_date": "29/11/2011", "last_updated_date": "24/04/2026", "general_url": "https://www.ema.europa.eu/en/use-macrolides-lincosamides-streptogramins-mls-animals-european-union-scientific-guideline" }, { "title": "Referentials Management Service (RMS)", "summary": "The European Medicines Agency (EMA) launched the Referentials Management Services (RMS) in 2017 to support regulatory activities throughout the European Union (EU).", "categories": "Human;Veterinary", "first_published_date": "19/11/2018", "last_updated_date": "23/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/referentials-management-service-rms" }, { "title": "Procurement and grants", "summary": "The European Medicines Agency (EMA) manages procurement through tenders published on a dedicated portal and in the official EU journal. EMA also awards limited grants and engages external experts via calls for expression of interest.", "categories": "Corporate", "first_published_date": "08/01/2010", "last_updated_date": "22/04/2026", "general_url": "https://www.ema.europa.eu/en/about-us/procurement-grants" }, { "title": "Submission dates", "summary": "The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants and marketing authorisation holders (MAHs), as well for members and experts of EMA's committees.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "20/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/submission-dates" }, { "title": "Respiratory syncytial virus (RSV)", "summary": "Respiratory syncytial virus (RSV) is a respiratory virus that affects people of any age and which spreads mostly during autumn and winter in the European Union (EU).", "categories": "Human", "first_published_date": "20/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/respiratory-syncytial-virus-rsv" }, { "title": "Recommendations on medication errors", "summary": "", "categories": "Human", "first_published_date": "31/01/2017", "last_updated_date": "16/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors/recommendations-medication-errors" }, { "title": "Human papillomavirus (HPV)", "summary": "Human papillomavirus (HPV) infection is highly contagious, transmitted predominantly through sexual activity. In most cases, HPV disappears on its own. However, in some cases, it can cause complications, including cancer. Vaccination can protect against such complications. The European Medicines Agency (EMA) evaluates, recommends and monitors vaccines against diseases such as measles in the European Union (EU).", "categories": "Human", "first_published_date": "28/04/2025", "last_updated_date": "16/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/human-papillomavirus-hpv" }, { "title": "Applying for orphan designation", "summary": "", "categories": "Human", "first_published_date": "09/02/2012", "last_updated_date": "16/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation" }, { "title": "CHMP opinions on consultation procedures on ancillary substances incorporated in a medical device", "summary": "The European Medicines Agency (EMA) publishes a consultation procedure public assessment report (CPAR) on the opinions prepared by its Committee for Medicinal Products for Human Use (CHMP) following a consultation procedure with EMA on the quality, safety, benefits and risks of ancillary substances incorporated in a medical device.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "16/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices/chmp-opinions-consultation-procedures-ancillary-substances-incorporated-medical-device" }, { "title": "EU Innovation Network (EU-IN)", "summary": "The EU Innovation Network (EU-IN) working group supports the European medicines regulatory network in facilitating the development of innovative medicines and associated technologies in the European Union (EU).", "categories": "Human;Veterinary", "first_published_date": "08/09/2023", "last_updated_date": "15/04/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/eu-innovation-network-eu" }, { "title": "Paediatric investigation plans: questions and answers", "summary": "This page provides answers to specific questions from companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver. Information is also available for companies that already have an agreed PIP.", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "14/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-questions-answers" }, { "title": "African Medicines Agency (African Union)", "summary": "The African Medicines Agency is a specialised agency of the African Union and its 55 Member States. It will work to improve governmental collaboration across Africa and help patients access medicines. The European Medicines Agency (EMA) and the European medicines regulatory network provide guidance, technical expertise and financial support to the African Union in setting up the agency.", "categories": "Corporate", "first_published_date": "13/12/2023", "last_updated_date": "14/04/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/african-medicines-agency-african-union" }, { "title": "Central register of data processing records", "summary": "The European Medicines Agency (EMA) maintains a central register of records of its personal data processing activities. These records outline the purposes of these activities and provides information on third-party transfers. EU law requires EMA to maintain this register.", "categories": "Corporate", "first_published_date": "24/01/2020", "last_updated_date": "13/04/2026", "general_url": "https://www.ema.europa.eu/en/about-us/data-protection-privacy-ema/central-register-data-processing-records" }, { "title": "Download medicine data", "summary": "You can download tables with detailed data on medicines from this page. This includes information on marketing authorisations of centrally authorised medicines and post-authorisation procedures.", "categories": "Human;Veterinary;Herbal", "first_published_date": "19/10/2018", "last_updated_date": "10/04/2026", "general_url": "https://www.ema.europa.eu/en/medicines/download-medicine-data" }, { "title": "Download website data in JSON data format", "summary": "You can download structured JSON data files to automatically access and retrieve up-to-date information and documents from the European Medicines Agency’s (EMA) website. These data files specifically target use via automated systems. Examples of the information available include data on medicines, guidelines, and documents along with their translations, where available. The JSON data files are updated twice a day.", "categories": "Human;Veterinary;Herbal;Corporate", "first_published_date": "19/11/2025", "last_updated_date": "10/04/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/download-website-data-json-data-format" }, { "title": "Union Product Database", "summary": "The Union Product Database (UPD) serves as a single source of information on all authorised veterinary medicines and their availability in European Union (EU) and European Economic Area (EEA) Member States. The European Medicines Agency (EMA) set up and maintains the veterinary medicines information website and the Union Product Database, in collaboration with the Member States and the European Commission.", "categories": "Veterinary", "first_published_date": "23/09/2019", "last_updated_date": "09/04/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database" }, { "title": "Core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/03/2015", "last_updated_date": "09/04/2026", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-normal-immunoglobulin-subcutaneous-intramuscular-use-scientific-guideline" }, { "title": "Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline", "summary": "This guideline describes the information to be included when a marketing authorisation application for SCIg/IMIg is made. It addresses biological data, pharmacokinetics, clinical trials and patient follow-up.", "categories": "Human", "first_published_date": "24/07/2015", "last_updated_date": "09/04/2026", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-human-normal-immunoglobulin-subcutaneous-or-intramuscular-administration-scig-imig-scientific-guideline" }, { "title": "COVID-19 vaccines: key facts", "summary": "The European Medicines Agency (EMA) continues to monitor the safety of vaccines against COVID-19 and to ensure that they offer protection in the European Union (EU), even though the public health emergency has ended. On this page you can find answers to key questions on the effectiveness and safety of COVID-19 vaccines in general, as well as on mRNA vaccines in particular. ", "categories": "Human", "first_published_date": "01/10/2020", "last_updated_date": "08/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-facts" }, { "title": "Vaccines: concerns, questions and false claims", "summary": "Information from the European Medicines Agency (EMA) addressing concerns, questions and false claims about vaccines.", "categories": "Human", "first_published_date": "21/11/2025", "last_updated_date": "08/04/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/vaccines-concerns-questions-false-claims" }, { "title": "Maximum residue limits (MRLs): Questions and answers", "summary": "The European Medicines Agency (EMA) makes available answers to the most frequently asked questions on maximum residue limits (MRLs).", "categories": "Veterinary", "first_published_date": "08/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/maximum-residue-limits-mrls-questions-answers" }, { "title": "Substances exempt from maximum residue limit evaluation", "summary": "Certain biological substances and substances that do not have any effect on the body may fall outside the Maximum Residue Limit Regulation. Such substances do not require a full MRL evaluation.", "categories": "Veterinary", "first_published_date": "08/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/substances-exempt-maximum-residue-limit-evaluation" }, { "title": "Submitting a maximum residue limit application", "summary": "The European Medicines Agency (EMA) makes available guidance on how to prepare and submit a maximum residue limits (MRLs) application.", "categories": "Veterinary", "first_published_date": "08/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/submitting-maximum-residue-limit-application" }, { "title": "Establishing maximum residue limits for veterinary medicines", "summary": "Maximum residue limits (MRLs) set safe limits for veterinary medicine residues in food consumed in the European Union (EU).", "categories": "Veterinary", "first_published_date": "08/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/establishing-maximum-residue-limits-veterinary-medicines" }, { "title": "Maximum residue limits (MRL)", "summary": "The maximum residue limit (MRL) is the highest concentration allowed for a residue in a food product obtained from an animal that has received a veterinary medicine or that has been exposed to a product used to kill or control germs or pests affecting animals.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "08/04/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl" }, { "title": "Animal health practitioners", "summary": "The European Medicines Agency (EMA) collaborates with animal health practitioners, or veterinarians, to ensure the safety and efficacy of veterinary medicines.", "categories": "Veterinary", "first_published_date": "08/04/2025", "last_updated_date": "08/04/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/animal-health-practitioners" }, { "title": "Veterinary medicine safety day", "summary": "The 'Veterinary Medicine Safety Day' raises awareness of the importance of safety monitoring for veterinary medicines. This campaign takes place each year on 8 April.", "categories": "Veterinary", "first_published_date": "08/04/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/animal-health-practitioners/veterinary-medicine-safety-day" }, { "title": "Industry Standing Group", "summary": "The European Medicine Agency (EMA) has an Industry Standing Group (ISG) to enable regular dialogue with industry stakeholders on issues relating to human medicines and medical devices. This group also facilitates the implementation of new legislation in the European Union (EU). ", "categories": "Human", "first_published_date": "28/09/2023", "last_updated_date": "07/04/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry/industry-standing-group" }, { "title": "Declaration of herbal substances and herbal preparations in herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary;Herbal", "first_published_date": "26/07/2007", "last_updated_date": "01/04/2026", "general_url": "https://www.ema.europa.eu/en/declaration-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Medicines for human use under evaluation", "summary": "Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU).", "categories": "Human", "first_published_date": "01/03/2012", "last_updated_date": "01/04/2026", "general_url": "https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation" }, { "title": "Scientific Advisory Group on Immune and Inflammatory Diseases", "summary": "The Scientific Advisory Group on Immune and Inflammatory Diseases (SAG-IMM)'s role is to provide independent recommendations on scientific, clinical or technical matters to the European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP). These recommendations refer to medicines addressing autoimmune, inflammatory diseases, respiratory and dermatological diseases, or any other scientific issues. The scientific advisory group is convened at the request of the CHMP.", "categories": "Human", "first_published_date": "05/08/2025", "last_updated_date": "01/04/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advisory-group-immune-inflammatory-diseases" }, { "title": "Paediatric addendum to the guideline on clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/02/2012", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-pulmonary-arterial-hypertension-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/12/2015", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-amyotrophic-lateral-sclerosis-scientific-guideline" }, { "title": "Human dietary exposure assessments", "summary": "EMA and the European Food Safety Authority (EFSA) promote a harmonised approach to assessing human dietary exposure to residues from veterinary medicines, feed additives and pesticides. They establish acceptable levels of these residues to ensure consumer safety in the European Union (EU).", "categories": "Veterinary", "first_published_date": "19/01/2023", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/maximum-residue-limits-mrl/human-dietary-exposure-assessments" }, { "title": "Opinions and letters of support on the qualification of novel methodologies for medicine development", "summary": "The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals. ", "categories": "Human", "first_published_date": "07/01/2011", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/opinions-letters-support-qualification-novel-methodologies-medicine-development" }, { "title": "Scientific publications", "summary": "The staff and experts of the European Medicines Agency (EMA) publish articles on the Agency's scientific activities in scientific publications, such as journals or textbooks.", "categories": "Corporate", "first_published_date": "28/01/2015", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/scientific-publications" }, { "title": "European medicines agencies network strategy (EMANS)", "summary": "The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) identify shared challenges, goals and priorities in five-year strategy documents, to give strategic direction to the work of the European medicines regulatory network. ", "categories": "Corporate", "first_published_date": "31/03/2015", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/european-medicines-agencies-network-strategy" }, { "title": "Pharmaceutical industry", "summary": "The pharmaceutical industry and medical device industry associations in the European Union (EU) are some of the European Medicines Agency's (EMA) main stakeholders. Interacting with pharmaceutical companies has been a major part of EMA's daily business since it began operating. Since 2022, EMA has also interacted with medical device companies, in line with EMA's extended mandate for dealing with public health emergencies. EMA's contacts with these stakeholders are guided by a formal framework that rests on the principles of accountability, transparency and broad representation.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry" }, { "title": "Newsletters", "summary": "The European Medicines Agency (EMA) publishes newsletters to provide updates on various topics to patients, healthcare professionals and the pharmaceutical industry.", "categories": "Human;Veterinary", "first_published_date": "04/07/2011", "last_updated_date": "31/03/2026", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/newsletters" }, { "title": "Classification of changes: questions and answers", "summary": "This page is intended to provide advice to Marketing Authorisation Holders of centrally authorised medicinal products about classification of changes to the Marketing Authorisation post-authorisation and certain variation classification categories. Revised topics are marked 'New' or 'Rev.' upon publication.", "categories": "Human", "first_published_date": "02/06/2016", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/classification-changes-questions-answers" }, { "title": "Changing the labelling and package leaflet (Article 61(3) notifications)", "summary": "This page addresses common questions from marketing-authorisation holders (MAHs) about Article-61(3) notifications. It outlines the European Medicines Agency's (EMA) position on issues typically discussed with MAHs during the post-authorisation phase.", "categories": "Human", "first_published_date": "01/01/2000", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-labelling-package-leaflet-article-613-notifications" }, { "title": "Transfer of marketing authorisation: questions and answers", "summary": "This page addresses questions from marketing-authorisation holders (MAHs) on transferring marketing authorisations. It also outlines European Medicine Agency’s (EMA) position on issues often discussed post-authorisation.", "categories": "Human", "first_published_date": "01/01/2000", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answers" }, { "title": "Submitting results of paediatric studies", "summary": "Marketing authorisation holders must submit the results of studies on authorised medicines conducted in children to the European Medicines Agency (EMA) or to national competent authorities in the European Union (EU).", "categories": "Human", "first_published_date": "01/01/2015", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/submitting-results-paediatric-studies" }, { "title": "Risk management plans (RMP) in post-authorisation phase: questions and answers", "summary": "This page is intended to provide advice to marketing authorisation holders of centrally authorised medicinal products about procedural and regulatory aspects to the risk management plan (RMP) lifecycle during the post authorisation phase.", "categories": "Human", "first_published_date": "02/06/2016", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/risk-management-plans-rmp-post-authorisation-phase-questions-answers" }, { "title": "Periodic safety update reports (PSURs)", "summary": "This page includes information on periodic safety update reports (PSURs), PSUR submission requirements, PSUR single assessment procedures (PSUSAs) and the European Union reference dates (EURD) list.", "categories": "Human", "first_published_date": "01/01/2015", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs" }, { "title": "Data quality framework for medicines regulation", "summary": "The data quality framework for European Union (EU) medicines regulation offers guidance and recommendations to assess the quality of datasets used in regulatory decision-making.", "categories": "Human", "first_published_date": "24/07/2024", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/data-quality-framework-medicines-regulation" }, { "title": "Post-authorisation measures: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation measures.", "categories": "Human", "first_published_date": "01/01/2000", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/pharmacovigilance-post-authorisation/post-authorisation-measures-questions-and-answers" }, { "title": "Post-authorisation safety studies (PASS)", "summary": "A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results.", "categories": "Human", "first_published_date": "01/01/2015", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass" }, { "title": "Type-IB variations: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on type-IB variations.", "categories": "Human", "first_published_date": "10/05/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ib-variations-questions-answers" }, { "title": "Grouping of variations: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on grouping of variations.", "categories": "Human", "first_published_date": "11/05/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/grouping-variations-questions-answers" }, { "title": "Worksharing: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on worksharing.", "categories": "Human", "first_published_date": "11/05/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/worksharing-questions-answers" }, { "title": "Biosimilar medicines: Overview", "summary": "A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU).", "categories": "Human", "first_published_date": "05/05/2017", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview" }, { "title": "Pre-authorisation guidance", "summary": "These questions and answers (Q&As) provide an overview of the European Medicines Agency's (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.", "categories": "Human", "first_published_date": "03/05/2016", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance" }, { "title": "Type-IA variations: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on type-IA variations.", "categories": "Human", "first_published_date": "01/01/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ia-variations-questions-answers" }, { "title": "Post-authorisation efficacy studies: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation efficacy studies (PAESs).", "categories": "Human", "first_published_date": "06/11/2015", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-efficacy-studies-questions-answers" }, { "title": "Type-II variations: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on type-II variations.", "categories": "Human", "first_published_date": "12/05/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ii-variations-questions-answers" }, { "title": "Extensions of marketing authorisations: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on type-II-variation and extension applications.", "categories": "Human", "first_published_date": "01/01/2010", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/extensions-marketing-authorisations-questions-answers" }, { "title": "Reflection paper on a tailored clinical approach in biosimilar development", "summary": "The European Medicines Agency (EMA) is exploring an improved approach for biosimilar medicine development and evaluation, while upholding strict European Union (EU) safety standards. This is outlined in a reflection paper on biosimilar development. Its aim is to utilise experience and technical advances to optimise biosimilar development and reduce the amount of clinical data required for the development and approval of biosimilar medicines in the EU.", "categories": "Human", "first_published_date": "01/02/2024", "last_updated_date": "27/03/2026", "general_url": "https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development" }, { "title": "Melatonin product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/melatonin-product-specific-bioequivalence-guidance" }, { "title": "Vaccine-preventable diseases: key facts", "summary": "Serious infectious diseases like polio, measles and the human papillomavirus (HPV) can and have been prevented by vaccines over the past decades. However, misinformation and disinformation on vaccine safety and effectiveness have been fuelling vaccine hesitancy at global level.", "categories": "Human", "first_published_date": "28/04/2025", "last_updated_date": "26/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts" }, { "title": "Vaccine Essentials: Supporting vaccine literacy", "summary": "'Vaccine Essentials’ is a communication tool that relies on science and regulation to address vaccine-related information gaps and concerns that healthcare professionals identify.", "categories": "Human", "first_published_date": "26/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/vaccine-essentials-supporting-vaccine-literacy" }, { "title": "Pharmaceutical quality system (PQS) effectiveness pilot project", "summary": "Marketing authorisation holders and manufacturers can nominate their sites to undergo on‑site pharmaceutical quality system (PQS) effectiveness assessments by European Economic Area (EEA) good manufacturing practice (GMP) inspectors", "categories": "Human;Veterinary", "first_published_date": "26/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/pharmaceutical-quality-system-pqs-effectiveness-pilot-project" }, { "title": "Clinical Trials Information System (CTIS): training and support", "summary": "The European Medicines Agency (EMA) makes training and supporting materials available to help users of the Clinical Trials Information System (CTIS) comply with their legal obligations. ", "categories": "Human", "first_published_date": "09/02/2021", "last_updated_date": "26/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis-training-support" }, { "title": "Eltrombopag product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "25/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/eltrombopag-product-specific-bioequivalence-guidance" }, { "title": "Changing the (invented) name of a centrally authorised medicine: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on changing the name of a medicine.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "25/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-invented-name-centrally-authorised-medicine-questions-answers" }, { "title": "Academia", "summary": "The European Medicines Agency (EMA) partners with academia to adapt to advances in science and technology. Areas of collaboration include regulatory science research, clinical trials and oncology.", "categories": "Human;Veterinary", "first_published_date": "03/04/2017", "last_updated_date": "24/03/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/academia" }, { "title": "Medicine shortage communications (MSC)", "summary": "Marketing authorisation holders (MAHs) may send medicine shortage communications (MSCs) to healthcare professionals to inform them of certain medicine shortages. The European Medicines Agency (EMA) publishes medicine shortages communications on this website.", "categories": "Human", "first_published_date": "09/12/2024", "last_updated_date": "24/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortage-communications-msc" }, { "title": "Availability of medicines before and during crises", "summary": "The European Medicines Agency (EMA) is key in coordinating the European Union's (EU) response to medicine supply issues caused by crises such as major events or public health emergencies.", "categories": "Human;Veterinary", "first_published_date": "08/11/2023", "last_updated_date": "24/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises" }, { "title": "Guidance on good manufacturing practice and good distribution practice: Questions and answers", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "24/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/guidance-good-manufacturing-practice-good-distribution-practice-questions-answers" }, { "title": "Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "23/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/good-manufacturing-practice-gmp-good-distribution-practice-gdp-inspectors-working-group" }, { "title": "Plant testing strategy in the risk assessment for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2011", "last_updated_date": "20/03/2026", "general_url": "https://www.ema.europa.eu/en/plant-testing-strategy-risk-assessment-veterinary-medicinal-products-scientific-guideline" }, { "title": "Guidance and template on the risk management plan (RMP) for novel therapy veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/guidance-template-risk-management-plan-rmp-novel-therapy-veterinary-medicinal-products-scientific-guideline" }, { "title": "Chemistry of active substances (chemistry of new active substances) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/10/2015", "last_updated_date": "20/03/2026", "general_url": "https://www.ema.europa.eu/en/chemistry-active-substances-chemistry-new-active-substances-scientific-guideline" }, { "title": "Electronic product information (ePI)", "summary": "The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic product information (ePI) for human medicines in the European Union (EU).", "categories": "Human", "first_published_date": "30/05/2023", "last_updated_date": "20/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi" }, { "title": "Quality Innovation Group", "summary": "The Quality Innovation Group (QIG) is an operational expert group set up to support the translation of innovative approaches to the design, manufacture and quality control of medicines.", "categories": "Corporate", "first_published_date": "03/10/2023", "last_updated_date": "18/03/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/quality-innovation-group" }, { "title": "Stakeholders and Communication", "summary": "The European Medicines Agency's (EMA) Stakeholders and Communication Division is responsible for ensuring that the Agency has a coherent, coordinated and consistent approach to stakeholder and partner relations management and communication.", "categories": "Corporate", "first_published_date": "16/09/2013", "last_updated_date": "16/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/stakeholders-communication" }, { "title": "Procedures for monograph and list entry establishment", "summary": "The establishment and publication of European Union (EU) herbal monographs and list entries is based on assessments by the European Medicines Agency's (EMA) Committee on Herbal Medicinal Products (HMPC), which follow the procedures listed on this page.", "categories": "Herbal", "first_published_date": "10/03/2016", "last_updated_date": "16/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/procedures-monograph-list-entry-establishment" }, { "title": "Qualification of non-mutagenic impurities - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/11/2018", "last_updated_date": "13/03/2026", "general_url": "https://www.ema.europa.eu/en/qualification-non-mutagenic-impurities-scientific-guideline" }, { "title": "Union list of critical medicines", "summary": "The Union list of critical medicines helps prevent issues with the supply and availability of medicines at European Union (EU) level.", "categories": "Human", "first_published_date": "16/12/2024", "last_updated_date": "13/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/availability-medicines-during-crises/union-list-critical-medicines" }, { "title": "Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)", "summary": "The role of the European Medicines Agency's (EMA) Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) is to ensure a robust response to medicine supply issues caused by major events or public-health emergencies.", "categories": "Human;Veterinary", "first_published_date": "28/09/2023", "last_updated_date": "13/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/executive-steering-group-shortages-medicinal-products" }, { "title": "European Sales and Use of Antimicrobials for Veterinary Medicine Working Group", "summary": "The European Sales and Use of Antimicrobials for Veterinary Medicine Working Group (ESUAvet) provides strategic guidance and recommendations to the European Medicines Agency (EMA) and its Committee for Veterinary Medicinal Products (CVMP). This guidance refers to the collection and analysis of data on sales volumes of veterinary antimicrobials and the use of antimicrobials in animals in the European Union (EU).", "categories": "Veterinary", "first_published_date": "02/10/2023", "last_updated_date": "13/03/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/european-sales-use-antimicrobials-veterinary-medicine-working-group-esuavet" }, { "title": "Development of anti-cancer medicinal products in paediatric patients - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/development-anti-cancer-medicinal-products-paediatric-patients-scientific-guideline" }, { "title": "Article 141(1) opinions on any scientific matter: veterinary medicines", "summary": "This page lists the opinions drawn up by the Committee for Veterinary Medicinal Products (CVMP) under Article 141(1)(c), (e) and (i) of the Veterinary Medicinal Product Regulation on any scientific matter related to medicines for use in animals.", "categories": "Veterinary", "first_published_date": "14/10/2010", "last_updated_date": "12/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines/article-1411-opinions-any-scientific-matter-veterinary-medicines" }, { "title": "Veterinary antibiotics: Dosage review and adjustment (ADRA) project", "summary": "The Dosage Review and Adjustment of Established Veterinary Antibiotics (ADRA) project aims to review and refine the dosage regimens of established veterinary antibiotics using non-experimental approaches.", "categories": "Veterinary", "first_published_date": "12/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/veterinary-antibiotics-dosage-review-adjustment-adra-project" }, { "title": "High-risk medical devices: consultation procedures", "summary": "Notified bodies must consult expert panels as part of the conformity assessment process for certain high-risk medical devices in the European Union (EU).", "categories": "", "first_published_date": "17/10/2024", "last_updated_date": "10/03/2026", "general_url": "https://www.ema.europa.eu/en/high-risk-medical-devices-consultation-procedures" }, { "title": "Supporting innovation", "summary": "A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).", "categories": "Human;Veterinary", "first_published_date": "22/03/2010", "last_updated_date": "10/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/supporting-innovation" }, { "title": "Portfolio and technology meetings", "summary": "Pharmaceutical companies with large portfolios can attend free, virtual meetings with European Medicines Agency (EMA). These meetings address development issues and anticipate future scientific and regulatory needs. They aim to support successful product portfolio development.", "categories": "Human;Veterinary", "first_published_date": "18/03/2025", "last_updated_date": "10/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/portfolio-technology-meetings" }, { "title": "Eligible healthcare professionals' organisations", "summary": "The European Medicines Agency (EMA) engages with a network of over thirty eligible organisations ensuring that the needs and concerns of a wide range of healthcare professionals across Europe are represented via direct contact with the EMA.", "categories": "Human", "first_published_date": "24/08/2012", "last_updated_date": "09/03/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/healthcare-professionals/eligible-healthcare-professionals-organisations" }, { "title": "Network Data Steering Group (NDSG)", "summary": "The Network Data Steering Group (NDSG) combines the former Big Data Steering Group and the Network Data Board into one data governance group. It aims to optimise data use and management in medicines regulation. This is for the benefit of public and animal health in the European Union (EU). The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) manage this group jointly.", "categories": "Human;Veterinary", "first_published_date": "24/07/2024", "last_updated_date": "09/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/network-data-steering-group-ndsg" }, { "title": "Organisation Management Service (OMS)", "summary": "The European Medicines Agency (EMA) has launched the Organisation Management Service (OMS) to support regulatory activities throughout the European Union (EU).", "categories": "Human;Veterinary", "first_published_date": "19/11/2018", "last_updated_date": "09/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/organisation-management-service-oms" }, { "title": "ICH E2D post-approval safety data management - scientific guideline", "summary": "This guideline provides guidance on definitions and standards for post-approval safety information management and reporting, as well as on good case management practices.", "categories": "Human", "first_published_date": "30/11/2003", "last_updated_date": "06/03/2026", "general_url": "https://www.ema.europa.eu/en/ich-e2d-post-approval-safety-data-management-scientific-guideline" }, { "title": "Orphan designation: Overview", "summary": "The European Medicines Agency (EMA) facilitates the development and authorisation of medicines for rare diseases, also called 'orphan medicines'.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "06/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview" }, { "title": "Variations not requiring assessment (veterinary medicines)", "summary": "Guidance is available from the European Medicines Agency (EMA) on variations for centrally authorised veterinary medicines not requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders need to submit as part of the variation procedure.", "categories": "Veterinary", "first_published_date": "20/01/2022", "last_updated_date": "05/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-not-requiring-assessment-veterinary-medicines" }, { "title": "Transferring a veterinary marketing authorisation", "summary": "This page provides guidance in the form of questions and answers (Q&As) on how to transfer a veterinary marketing authorisation.", "categories": "Veterinary", "first_published_date": "16/12/2010", "last_updated_date": "05/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/transferring-veterinary-marketing-authorisation" }, { "title": "Pre-authorisation guidance under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6)", "summary": "Pre-authorisation procedural guidance is available from the European Medicines Agency (EMA) on initial marketing authorisation procedures for centrally authorised veterinary medicines under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6).", "categories": "Veterinary", "first_published_date": "27/07/2021", "last_updated_date": "05/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/pre-authorisation-guidance-under-veterinary-medicinal-products-regulation-regulation-eu-2019-6" }, { "title": "Product-information requirements for veterinary medicines", "summary": "Information on the linguistic aspects of the product information for veterinary medicines, which includes the summary of product characteristics, labelling and package leaflet. It explains the content that should be included in these documents, as well as standard headings and the most commonly used standard statements and terms in all official European Union languages plus Icelandic and Norwegian, and defines the format and layout for the product information.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "05/03/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/product-information-requirements-veterinary-medicines" }, { "title": "Artificial intelligence", "summary": "The European medicines regulatory network aims to enable regulatory systems in the European Union (EU) to use the capabilities of artificial intelligence (AI) while managing its risks. Capabilities include personal productivity, process automation, better insights into data and decision-making support for the benefit of public and animal health.", "categories": "Human;Veterinary", "first_published_date": "24/07/2024", "last_updated_date": "03/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/artificial-intelligence" }, { "title": "Fees for veterinary medicines", "summary": "Guidance in a question-and-answer format on the European Medicines Agency’s fees for the assessment of and services relating to veterinary medicines, in line with Regulation (EU) 2024/568 (the New Fee Regulation)", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/04/2025", "last_updated_date": "02/03/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-veterinary-medicines" }, { "title": "Medical devices", "summary": "Medical devices are products or equipment intended for a medical purpose. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in a number of regulatory processes.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "02/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices" }, { "title": "Non-clinical development and evaluation of microbiome-based medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/03/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/non-clinical-development-evaluation-microbiome-based-medicinal-products-scientific-guideline" }, { "title": "Quality of medicines: questions and answers - Part 1", "summary": "These questions and answers address a number of questions on matters related to the quality of medicines.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "02/03/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-medicines-questions-answers-introduction/quality-medicines-questions-answers-part-1" }, { "title": "Fees payable to the European Medicines Agency: Guidance for all applicants", "summary": "General guidance in a question-and-answer format on the European Medicines Agency’s fees for the assessment of and services, in line with Regulation (EU) 2024/568 (the New Fee Regulation)", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/04/2025", "last_updated_date": "25/02/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-payable-european-medicines-agency-guidance-all-applicants" }, { "title": "EudraVigilance: electronic reporting", "summary": "Marketing authorisation holders and sponsors of clinical trials must report and evaluate suspected adverse drug reactions both during development and after a medicine is authorised in the EEA and also submit the data of their authorised or investigational products to the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD). National competent authorities must report reactions they receive from patients or healthcare professionals to the EV system.", "categories": "Human", "first_published_date": "17/06/2016", "last_updated_date": "24/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-electronic-reporting" }, { "title": "EudraVigilance training and support", "summary": "The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the protection of public health in the European Union (EU).", "categories": "Human", "first_published_date": "08/04/2016", "last_updated_date": "24/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-training-support" }, { "title": "ICH E22 General considerations for patient preference studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/12/2025", "last_updated_date": "24/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-e22-general-considerations-patient-preference-studies-scientific-guideline" }, { "title": "ICH Q14 Analytical procedure development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/04/2022", "last_updated_date": "24/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-q14-analytical-procedure-development-scientific-guideline" }, { "title": "ICH M4Q - The Common Technical Document for the registration of pharmaceuticals for human use - Quality - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2003", "last_updated_date": "20/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-m4q-common-technical-document-registration-pharmaceuticals-human-use-quality-scientific-guideline" }, { "title": "Guideline on quality aspects of mRNA vaccines for veterinary use", "summary": "", "categories": "Veterinary", "first_published_date": "08/01/2025", "last_updated_date": "20/02/2026", "general_url": "https://www.ema.europa.eu/en/guideline-quality-aspects-mrna-vaccines-veterinary-use" }, { "title": "ICH Q2(R2) Validation of analytical procedures - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/1994", "last_updated_date": "20/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-q2r2-validation-analytical-procedures-scientific-guideline" }, { "title": "Risk management requirements for elemental impurities in veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/10/2017", "last_updated_date": "20/02/2026", "general_url": "https://www.ema.europa.eu/en/risk-management-requirements-elemental-impurities-veterinary-medicinal-products-scientific-guideline" }, { "title": "Immune and Inflammatory Diseases Working Party (IIWP)", "summary": "The European Medicines Agency's (EMA) Immune and Inflammatory Diseases Working Party (IIWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to carry out specific tasks related to rheumatology and immunology (allergy, transplant and primary immunodeficiencies), pulmonology, gastroenterology, hepatology, nephrology, dermatology and urology.", "categories": "Human;Corporate", "first_published_date": "03/10/2023", "last_updated_date": "17/02/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/immune-inflammatory-diseases-working-party-iiwp" }, { "title": "Clinical Pharmacology Operational Expert Group", "summary": "The Clinical Pharmacology Operational Expert Group develops and maintains product-specific bioequivalence guidelines to support assessment by the network and set standards for industry. It also provides support to CHMP, CMDh and SAWP regarding clinical pharmacology and generic topics.", "categories": "Human;Corporate", "first_published_date": "16/02/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/clinical-pharmacology-operational-expert-group" }, { "title": "ICH E20 adaptive designs for clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/06/2025", "last_updated_date": "16/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-e20-adaptive-designs-clinical-trials-scientific-guideline" }, { "title": "Good pharmacovigilance practices (GVP)", "summary": "Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.", "categories": "Human", "first_published_date": "22/02/2012", "last_updated_date": "16/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp" }, { "title": "Clinical investigation of medicinal products in the treatment of Myasthenia Gravis", "summary": "", "categories": "Human", "first_published_date": "13/02/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-myasthenia-gravis" }, { "title": "Paediatric investigation plans", "summary": "A paediatric investigation plan (PIP) is a development plan aimed at ensuring that the necessary data are obtained through studies in children, to support the authorisation of a medicine for children. All applications for marketing authorisation for new medicines have to include the results of studies as described in an agreed PIP, unless the medicine is exempt because of a deferral or waiver.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "12/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans" }, { "title": "CVMP recommendations on limited market classification and eligibility for authorisation under Article 23", "summary": "The European Medicines Agency publishes the recommendations by the Committee for Veterinary Medicinal Products (CVMP) under the limited market provisions of the Veterinary Medicinal Products Regulation. These include classifications on limited market according to Article 4(29) and eligibility under Article 23.", "categories": "Veterinary", "first_published_date": "21/04/2023", "last_updated_date": "12/02/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/veterinary-limited-markets/cvmp-recommendations-limited-market-classification-eligibility-authorisation-under-article-23" }, { "title": "Extended EudraVigilance medicinal product dictionary (XEVMPD) training", "summary": "The European Medicines Agency (EMA) offers training on how to submit and retrieve medicinal product data using the extended EudraVigilance medicinal product dictionary (XEVMPD), also known as Article 57 database. This is aimed at ensuring the quality of data in the XEVMPD on authorised or investigational medicinal products. At least one user from each marketing authorisation holder or sponsor of clinical trials should receive training.", "categories": "Human", "first_published_date": "31/01/2014", "last_updated_date": "11/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/extended-eudravigilance-medicinal-product-dictionary-xevmpd-training" }, { "title": "ICH M15 guideline on general principles for model-informed drug development - Scientific guideline", "summary": "This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission.", "categories": "Human", "first_published_date": "29/11/2004", "last_updated_date": "11/02/2026", "general_url": "https://www.ema.europa.eu/en/ich-m15-guideline-general-principles-model-informed-drug-development-step-2b-scientific-guideline" }, { "title": "Aliskiren product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/06/2018", "last_updated_date": "10/02/2026", "general_url": "https://www.ema.europa.eu/en/aliskiren-product-specific-bioequivalence-guidance" }, { "title": "Ledipasvir/sofosbuvir product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "31/01/2018", "last_updated_date": "10/02/2026", "general_url": "https://www.ema.europa.eu/en/ledipasvir-sofosbuvir-product-specific-bioequivalence-guidance" }, { "title": "Archive of development of good pharmacovigilance practices", "summary": "", "categories": "Human", "first_published_date": "12/04/2013", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp/archive-development-good-pharmacovigilance-practices" }, { "title": "Superseded pharmacovigilance guidance documents", "summary": "", "categories": "Human", "first_published_date": "12/04/2013", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp/superseded-pharmacovigilance-guidance-documents" }, { "title": "Fees for human medicines", "summary": "Guidance in a question-and-answer format on the European Medicines Agency’s fees for the assessment of and services relating to human medicines, in line with Regulation (EU) 2024/568 (the New Fee Regulation)", "categories": "Human;Corporate", "first_published_date": "15/04/2025", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-human-medicines" }, { "title": "Annual fees payable to the European Medicines Agency", "summary": "Guidance on the annual fees and remuneration payable to the European Medicines Agency in line with Regulation (EU) 2024/568. This is known as the 'New fee regulation'.", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/04/2025", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/annual-fees-payable-european-medicines-agency" }, { "title": "Working parties and other groups", "summary": "The European Medicines Agency (EMA) has a number of working parties and related groups in place. They advise EMA's scientific committees on issues relating to their fields of expertise. EMA introduced areas of domain governance that oversee the work carried out by its working parties and related groups. ", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups" }, { "title": "Medicine shortages and availability issues", "summary": "Improving the availability of medicines authorised in the European Union (EU) is a key priority for the European Medicines Agency (EMA) and the European medicines regulatory network. Shortages or other problems with the availability of medicines create challenges for the medicine supply chain, potentially seriously impacting human and animal health. ", "categories": "Human;Veterinary", "first_published_date": "04/11/2013", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues" }, { "title": "Drug Shortages Global Regulatory Working Group", "summary": "The European Medicines Agency (EMA) is a member of the Drug Shortages Global Regulatory Working Group (DSGR WG). This international working group fosters collaboration to prevent, mitigate and monitor medicine shortages with a global impact.", "categories": "Human", "first_published_date": "10/06/2025", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/drug-shortages-global-regulatory-working-group" }, { "title": "Medicines during pregnancy and breastfeeding", "summary": "The European Medicines Agency (EMA) ensures accurate information is available on medicine use during pregnancy and breastfeeding. EMA identifies gaps in related data and implements strategies to improve evidence on medicine safety. These initiatives enable healthcare providers and patients to make informed decisions about treatment options during pregnancy and breastfeeding.", "categories": "Human", "first_published_date": "04/06/2025", "last_updated_date": "06/02/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/medicines-during-pregnancy-breastfeeding" }, { "title": "Epidemiological data on blood transmissible infections - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/10/2010", "last_updated_date": "04/02/2026", "general_url": "https://www.ema.europa.eu/en/epidemiological-data-blood-transmissible-infections-scientific-guideline" }, { "title": "Interested Parties to the HMPC", "summary": "", "categories": "Herbal", "first_published_date": "31/12/2009", "last_updated_date": "04/02/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/hmpc-working-parties-other-groups/interested-parties-hmpc" }, { "title": "National competent authorities (human)", "summary": "The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for medicinal products for human use.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "04/02/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-human" }, { "title": "Human Medicines", "summary": "The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. It also works to facilitate access to and the optimal use of medicines, for the benefit of patients in the European Union. ", "categories": "Corporate", "first_published_date": "02/03/2020", "last_updated_date": "02/02/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/human-medicines" }, { "title": "EU enlargement", "summary": "The European Medicines Agency (EMA) takes part in projects to foster links with European Union (EU) enlargement countries, to lay the foundations of future co-operation in EMA's networks.", "categories": "Corporate", "first_published_date": "25/02/2013", "last_updated_date": "02/02/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-enlargement" }, { "title": "Obtaining and maintaining a scientific opinion on a medicine for use outside the European Union", "summary": "The European Medicines Agency (EMA) provides guidance on obtaining and maintaining a scientific opinion under the 'EU-M4all' procedure (previously known as Article 58) on high priority human medicines intended for markets outside of the European Union (EU).", "categories": "Human", "first_published_date": "24/05/2018", "last_updated_date": "30/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/medicines-use-outside-european-union/obtaining-maintaining-scientific-opinion-medicine-use-outside-european-union" }, { "title": "Use of Bayesian methods in clinical development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/01/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/use-bayesian-methods-clinical-development-scientific-guideline" }, { "title": "Clinical evaluation of diagnostic agents - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/07/2009", "last_updated_date": "30/01/2026", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-diagnostic-agents-scientific-guideline" }, { "title": "Eligible patients and consumers' organisations", "summary": "The European Medicines Agency (EMA) engages with a network of eligible patients and consumers organisations, ensuring that their needs and concerns are represented via direct contact with EMA.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "29/01/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers/eligible-patients-consumers-organisations" }, { "title": "Questions and answers on how to use a CEP in the context of a Marketing Authorisation Application or a Marketing Authorisation Variation", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/02/2024", "last_updated_date": "28/01/2026", "general_url": "https://www.ema.europa.eu/en/questions-answers-how-use-cep-context-marketing-authorisation-application-or-marketing-authorisation-variation" }, { "title": "ICH Q3E Extractables and leachables - scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/08/2025", "last_updated_date": "28/01/2026", "general_url": "https://www.ema.europa.eu/en/ich-q3e-extractables-leachables-scientific-guideline" }, { "title": "One substance - one assessment (OSOA): EU collaboration on chemicals-related data", "summary": "Information on EMA's role in helping implement the One substance - one assessment (OSOA) framework. This framework aims to improve coordination, efficiency and transparency of chemical safety assessments in Europe.", "categories": "Human;Veterinary", "first_published_date": "28/01/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/one-substance-one-assessment-osoa-eu-collaboration-chemicals-related-data" }, { "title": "Questions and answers regarding co-processed excipients used in solid oral dosage forms", "summary": "", "categories": "Human;Veterinary", "first_published_date": "11/09/2024", "last_updated_date": "28/01/2026", "general_url": "https://www.ema.europa.eu/en/questions-answers-regarding-co-processed-excipients-used-solid-oral-dosage-forms" }, { "title": "Handling competing interests", "summary": "The European Medicines Agency (EMA) takes care to ensure that its staff, scientific experts and Management Board do not have any financial or other interests that could affect their impartiality. EMA has separate policies in place for these groups.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "27/01/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/handling-competing-interests" }, { "title": "Scientific Advisory Group on Vaccines and Therapies for Infectious Diseases (SAG-V&ID)", "summary": "The Scientific Advisory Group on Vaccines and Therapies for Infectious Diseases (SAG-V&ID) is a scientific advisory group set up to support EMA's Committee for Medicinal Products for Human Use (CHMP).", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "27/01/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advisory-group-vaccines-therapies-infectious-diseases-sag-vid" }, { "title": "Avian influenza (bird flu)", "summary": "Avian influenza, also known as bird flu, is a viral disease that can be highly pathogenic in birds. While the public health risk of this disease is low, authorities such as the European Medicines Agency (EMA) remain alert.", "categories": "Human;Veterinary", "first_published_date": "14/04/2023", "last_updated_date": "27/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/avian-influenza-bird-flu" }, { "title": "Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease - Scientific guideline", "summary": "This guideline provides guidance on the evaluation of medicinal products in the treatment of chronic peripheral arterial occlusive disease.", "categories": "Human", "first_published_date": "25/04/2002", "last_updated_date": "27/01/2026", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-peripheral-arterial-occlusive-disease-scientific-guideline" }, { "title": "Pharmaceutical quality of inhalation and nasal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/04/2006", "last_updated_date": "27/01/2026", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-quality-inhalation-nasal-products-scientific-guideline" }, { "title": "Environmental management", "summary": "The European Medicines Agency (EMA) is committed to help protect the environment for current and future generations. EMA holds a certificate for European Union (EU) eco-management and auditing scheme (EMAS) and runs several initiatives to reduce its environmental footprint.", "categories": "Corporate", "first_published_date": "17/02/2025", "last_updated_date": "26/01/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/environmental-management" }, { "title": "Medical device expert panels", "summary": "In the European Union (EU), medical device expert panels provide input on the clinical and performance assessment of certain high-risk medical devices and in vitro diagnostic medical devices for their conformity assessments.", "categories": "Human", "first_published_date": "17/10/2024", "last_updated_date": "26/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/medical-device-expert-panels" }, { "title": "Questions and answers on the use of Product Lifecycle Management (PLCM) document - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/01/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/questions-answers-use-product-lifecycle-management-plcm-document-scientific-guideline" }, { "title": "Demonstration of efficacy of ectoparasiticides - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/09/1994", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/demonstration-efficacy-ectoparasiticides-scientific-guideline" }, { "title": "Owner assessment as efficacy parameter - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/01/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/owner-assessment-efficacy-parameter-scientific-guideline" }, { "title": "Veterinary medicinal products controlling Varroa destructor parasitosis in bees - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/11/2010", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-medicinal-products-controlling-varroa-destructor-parasitosis-bees-scientific-guideline" }, { "title": "Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "12/11/2007", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/testing-evaluation-efficacy-antiparasitic-substances-treatment-prevention-tick-flea-infestations-dogs-cats-scientific-guideline" }, { "title": "Environmental risk assessment for immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/07/1996", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Design of studies to evaluate the safety and efficacy of fish vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "29/11/2011", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/design-studies-evaluate-safety-efficacy-fish-vaccines-scientific-guideline" }, { "title": "User safety for immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/04/2007", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/user-safety-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "29/07/2013", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/requirements-combined-vaccines-associations-immunological-veterinary-medicinal-products-ivmps-scientific-guideline" }, { "title": "Investigation and assessment of cardiovascular safety of anticancer medicinal products", "summary": "", "categories": "Human", "first_published_date": "31/07/2024", "last_updated_date": "23/01/2026", "general_url": "https://www.ema.europa.eu/en/investigation-assessment-cardiovascular-safety-anticancer-medicinal-products" }, { "title": "Good Clinical Practice Inspectors Working Group", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "20/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice/good-clinical-practice-inspectors-working-group" }, { "title": "Submission deadlines for orphan designations", "summary": "This page lists the submission deadlines for applications for orphan designation.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "19/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation/submission-deadlines-orphan-designations" }, { "title": "European Shortages Monitoring Platform (ESMP)", "summary": "The European Medicines Agency (EMA) uses the European Shortages Monitoring Platform (ESMP) to gather information about medicine availability, supply and demand in order to prevent, detect, and manage human medicine shortages in the European Union (EU) and European Economic Area (EEA).", "categories": "Corporate", "first_published_date": "18/04/2024", "last_updated_date": "16/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform-esmp" }, { "title": "Medicine evaluation figures", "summary": "The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates. The documents on this page contain factual information on medicines evaluation, presented on an annual and monthly basis.", "categories": "Human;Veterinary", "first_published_date": "08/02/2010", "last_updated_date": "15/01/2026", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/medicine-evaluation-figures" }, { "title": "International Coalition of Medicines Regulatory Authorities (ICMRA)", "summary": "The European Medicines Agency (EMA) is a member of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA is a voluntary, executive-level entity of worldwide medicines regulatory authorities set up to provide strategic coordination, advocacy and leadership.", "categories": "Human", "first_published_date": "20/11/2014", "last_updated_date": "14/01/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmra" }, { "title": "Medicinal products used in combination with a medical device", "summary": "Guidance on the marketing authorisation dossier requirements for a medicine when it is used with a medical device and information on conformity assessment requirements for the device component", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "12/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/medicinal-products-used-combination-medical-device" }, { "title": "Medical devices made of substances that are systemically absorbed", "summary": "Information on the European Medicines Agency's (EMA) role in the regulatory process for medical devices made of substances that are systemically absorbed.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "12/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/medical-devices-made-substances-are-systemically-absorbed" }, { "title": "Medical devices with an ancillary medicinal substance", "summary": "Notified bodies in the European Union must seek a scientific opinion from the European Medicines Agency (EMA) on the quality and safety of certain ancillary substances incorporated in a medical device.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "12/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/medical-devices-ancillary-medicinal-substance" }, { "title": "Substance and product data management services", "summary": "The European Medicines Agency (EMA) is delivering a Product Management Service (PMS) and a Substance Management Service (SMS) to support regulatory activities in the European Union (EU).", "categories": "Human", "first_published_date": "06/07/2017", "last_updated_date": "12/01/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/substance-product-data-management-services" }, { "title": "Financial management and budgetary reporting", "summary": "This page lists the Agency's annual budgets and accounts, as well as related documents. It also lists the Agency's financial regulation and implementing rules.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "08/01/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/financial-management-budgetary-reporting" }, { "title": "Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings", "summary": "The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meets in preparation for or during a public health emergency or a major event. The European Medicines Agency (EMA) publishes the agendas and minutes of the meetings of the MSSG as well as adopted documents, when available, on the meetings pages.", "categories": "Human;Veterinary", "first_published_date": "11/05/2022", "last_updated_date": "06/01/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/executive-steering-group-shortages-medicinal-products/executive-steering-group-shortages-safety-medicinal-products-mssg-meetings" }, { "title": "Healthcare Professionals' Working Party", "summary": "The Healthcare Professionals' Working Party (HCPWP) provides a platform for exchange of information and discussion of issues of common interest between the European Medicines Agency and healthcare professionals.", "categories": "Human", "first_published_date": "15/02/2016", "last_updated_date": "06/01/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/healthcare-professionals-working-party" }, { "title": "Emergency Task Force (ETF)", "summary": "The Emergency Task Force (ETF) is an advisory and support body that handles regulatory activities in preparation for and during a public-health emergency, such as a pandemic.", "categories": "Human", "first_published_date": "06/05/2022", "last_updated_date": "05/01/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/emergency-task-force-etf" }, { "title": "Funding", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "22/12/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/funding" }, { "title": "Information management", "summary": "Information management is a critical enabler of the European Medicines Agency's (EMA) mission to promote and protect public and animal health.", "categories": "Corporate", "first_published_date": "20/10/2016", "last_updated_date": "19/12/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/information-management" }, { "title": "Allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/02/2024", "last_updated_date": "18/12/2025", "general_url": "https://www.ema.europa.eu/en/allergen-products-development-immunotherapy-allergy-diagnosis-moderate-low-sized-study-populations-scientific-guideline" }, { "title": "Medicine shortages and availability issues: guidance for companies", "summary": "Guidance to pharmaceutical industry actors on maintaining a continuous supply of their medicines in the European Union (EU).", "categories": "Human;Veterinary", "first_published_date": "07/11/2023", "last_updated_date": "17/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companies" }, { "title": "European Shortages Monitoring Platform (ESMP): Interoperability with national and pharmaceutical industry systems", "summary": "The European Shortages Monitoring Platform (ESMP) enables easy and consistent data sharing across the systems of national competent authorities (NCAs) and marketing authorisation holders (MAHs) for monitoring and reporting medicine shortages in the European Union (EU).", "categories": "", "first_published_date": "16/12/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform-esmp/european-shortages-monitoring-platform-esmp-interoperability-national-pharmaceutical-industry-systems" }, { "title": "European Shortages Monitoring Platform (ESMP): Guidance, training materials and events", "summary": "The European Medicines Agency (EMA) provides guidance and training materials to help stakeholders of the European Shortages Monitoring Platform (ESMP) adopt and use the platform. EMA also organises events to support them and facilitate their involvement in the platform’s development.", "categories": "", "first_published_date": "16/12/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/european-shortages-monitoring-platform-esmp/european-shortages-monitoring-platform-esmp-guidance-training-materials-events" }, { "title": "Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/09/2006", "last_updated_date": "12/12/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-patients-acute-respiratory-distress-syndrome-scientific-guideline" }, { "title": "Stability testing for applications for variations to marketing authorisation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/04/2014", "last_updated_date": "12/12/2025", "general_url": "https://www.ema.europa.eu/en/stability-testing-applications-variations-marketing-authorisation-scientific-guideline" }, { "title": "How to submit information on authorised and investigational medicines", "summary": "Marketing-authorisation holders and sponsors of clinical trials are required to submit information on authorised and investigational medicines to the European Medicines Agency (EMA).", "categories": "Human", "first_published_date": "31/01/2014", "last_updated_date": "11/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/reporting-requirements-marketing-authorisation-holders/how-submit-information-authorised-investigational-medicines" }, { "title": "Questions and answers on post approval change management protocols - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/04/2012", "last_updated_date": "11/12/2025", "general_url": "https://www.ema.europa.eu/en/questions-answers-post-approval-change-management-protocols-scientific-guideline" }, { "title": "Radiopharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/11/2008", "last_updated_date": "10/12/2025", "general_url": "https://www.ema.europa.eu/en/radiopharmaceuticals-scientific-guideline" }, { "title": "Dextrans - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2018", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/dextrans-scientific-guideline" }, { "title": "Cancer Medicines Forum", "summary": "The European Medicines Agency (EMA) set up the Cancer Medicines Forum to help advance research into optimising cancer treatments and foster high standards in cancer care in the European Union (EU).", "categories": "Human", "first_published_date": "28/10/2024", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines/cancer-medicines-forum" }, { "title": "Combination Products Operational Group", "summary": "The Combination Products Operational Group (COMBO) fosters dialogue and addresses regulatory challenges for combination products. These are medicinal products used in combination with a medical device.", "categories": "Human", "first_published_date": "04/11/2025", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/combination-products-operational-group" }, { "title": "European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance reports", "summary": "The European Sales and Use of Antimicrobials for Veterinary Medicine (ESUAvet) annual surveillance reports present data from across the European Union (EU) and European Economic Area (EEA) countries. The European Medicines Agency (EMA) centralises, analyses and publishes these data to monitor the EU's progress towards prudent use of antimicrobials in animals.", "categories": "Veterinary", "first_published_date": "31/03/2025", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/european-sales-use-antimicrobials-veterinary-medicine-esuavet-annual-surveillance-reports" }, { "title": "Antimicrobial Sales and Use Platform", "summary": "The European Medicines Agency (EMA) has developed the Antimicrobial Sales and Use (ASU) Platform to support the mandatory collection and reporting of data on antimicrobial medicinal products in animals from across the European Union (EU) / European Economic Area (EEA). These data help strengthen EU action against antimicrobial resistance in humans and animals under the One Health approach.", "categories": "", "first_published_date": "20/11/2023", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/antimicrobial-sales-use-platform" }, { "title": "Questions and answers for biological medicinal products", "summary": "", "categories": "Human", "first_published_date": "18/09/2023", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guidelines/questions-answers-biological-medicinal-products" }, { "title": "European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): 2009 - 2023", "summary": "The European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project ran from 2009 to 2023 and reported on the sales of antimicrobial medicines used in animals across the European Union (EU). This type of information was essential to identifying possible risk factors that could lead to the development and spread of antimicrobial resistance in animals.", "categories": "Veterinary", "first_published_date": "21/05/2010", "last_updated_date": "09/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/european-surveillance-veterinary-antimicrobial-consumption-esvac-2009-2023" }, { "title": "Union Product Database: release notes", "summary": "", "categories": "Veterinary", "first_published_date": "21/10/2020", "last_updated_date": "08/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database/union-product-database-release-notes" }, { "title": "Good pharmacogenomic practice - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/08/2014", "last_updated_date": "08/12/2025", "general_url": "https://www.ema.europa.eu/en/good-pharmacogenomic-practice-scientific-guideline" }, { "title": "Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'", "summary": "", "categories": "Human", "first_published_date": "01/07/2003", "last_updated_date": "05/12/2025", "general_url": "https://www.ema.europa.eu/en/annex-european-commission-guideline-excipients-labelling-package-leaflet-medicinal-products-human-use" }, { "title": "Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/04/2014", "last_updated_date": "04/12/2025", "general_url": "https://www.ema.europa.eu/en/interim-guidance-enhanced-safety-surveillance-seasonal-influenza-vaccines-eu-scientific-guideline" }, { "title": "Antiviral medicines for pandemic influenza", "summary": "This European Medicines Agency (EMA) is responsible for reviewing data on antiviral medicines submitted for authorisation in the European Union (EU) via the centralised procedure.", "categories": "Human", "first_published_date": "03/09/2010", "last_updated_date": "04/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/antiviral-medicines-pandemic-influenza" }, { "title": "Signal management (veterinary medicines)", "summary": "The European Medicines Agency (EMA), regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals associated with veterinary medicines on the European market. This involves collecting and analysing safety data to identify and evaluate potential safety issues, so regulatory actions can be taken if needed to protect animal and human health.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "04/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/signal-management-veterinary-medicines" }, { "title": "Veterinary good pharmacovigilance practices (VGVP)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "04/12/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/veterinary-good-pharmacovigilance-practices-vgvp" }, { "title": "Safety of medicines", "summary": "The European Medicines Agency (EMA) helps make sure that medicines used in the European Union are safe, effective and of high quality. EMA carefully evaluates medicines before they are approved and continues to monitor their safety once they are on the market.", "categories": "Human", "first_published_date": "06/11/2025", "last_updated_date": "03/12/2025", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/safety-medicines" }, { "title": "Outcomes of imposed non-interventional post-authorisation safety studies", "summary": "", "categories": "Human", "first_published_date": "23/02/2017", "last_updated_date": "02/12/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass/outcomes-imposed-non-interventional-post-authorisation-safety-studies" }, { "title": "Clinical investigation of medicinal products in the treatment of Parkinson's disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/07/2012", "last_updated_date": "01/12/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-parkinsons-disease-scientific-guideline" }, { "title": "National competent authorities (veterinary)", "summary": "The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for veterinary medicines.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "28/11/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/national-competent-authorities-veterinary" }, { "title": "Procedural advice for veterinary vaccine antigen master file (VAMF) certification - Procedural Guidance", "summary": "", "categories": "Veterinary", "first_published_date": "12/11/2021", "last_updated_date": "28/11/2025", "general_url": "https://www.ema.europa.eu/en/procedural-advice-veterinary-vaccine-antigen-master-file-vamf-certification-procedural-guidance" }, { "title": "Procedural advice for vaccine platform technology master file (vPTMF) certification - Procedural Guidance", "summary": "", "categories": "Veterinary", "first_published_date": "20/05/2022", "last_updated_date": "28/11/2025", "general_url": "https://www.ema.europa.eu/en/procedural-advice-vaccine-platform-technology-master-file-vptmf-certification-procedural-guidance" }, { "title": "Ethical use of animals in medicine testing", "summary": "The European Medicines Agency (EMA) supports the implementation of the so-called 3Rs principles - replace, reduce and refine - for the ethical use of animals in medicine testing across the European Union (EU). These principles encourage alternatives to the use of animals in the testing of medicines while safeguarding scientific quality and improving animal welfare where the use of animals cannot be avoided.", "categories": "Human;Veterinary", "first_published_date": "20/04/2018", "last_updated_date": "27/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing" }, { "title": "Veterinary limited markets", "summary": "The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) introduced a specific authorisation route for medicines intended for veterinary limited markets in the European Union (EU) when it became applicable on 28 January 2022. ", "categories": "Veterinary", "first_published_date": "02/09/2021", "last_updated_date": "27/11/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/veterinary-limited-markets" }, { "title": "Legal notice", "summary": "Information on the European Medicines Agency's (EMA)  website is subject to a disclaimer and copyright and limited reproduction notices.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "27/11/2025", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/legal-notice" }, { "title": "Medicines authorised during pandemic", "summary": "During the 2009 (H1N1) pandemic, EMA made recommendations on the use of vaccines and antiviral medicines to be used to prevent or treat pandemic influenza.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "26/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/2009-h1n1-influenza-pandemic/medicines-authorised-during-pandemic" }, { "title": "Paediatric investigation plans: Templates and forms", "summary": "This page lists the templates and forms required by companies wishing to submit a paediatric application.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "26/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/paediatric-investigation-plans-templates-forms" }, { "title": "2009 (H1N1) influenza pandemic", "summary": "EMA played a key role in the authorisation of medicines and vaccines for use during the 2009 (H1N1) influenza pandemic.", "categories": "Human", "first_published_date": "03/09/2010", "last_updated_date": "25/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/2009-h1n1-influenza-pandemic" }, { "title": "Pandemic influenza", "summary": "The European Medicines Agency (EMA) is responsible for reviewing data on pandemic influenza vaccines and antiviral medicines eligible for authorisation in the European Union (EU) via the centralised procedure. It also provides scientific and regulatory support to EU Member States in taking the necessary public health decisions during an influenza pandemic.", "categories": "Human", "first_published_date": "01/01/2010", "last_updated_date": "25/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza" }, { "title": "Vaccines for pandemic influenza", "summary": "The European Medicines Agency (EMA) is responsible for reviewing data on pandemic influenza vaccines eligible for authorisation in the European Union (EU) via the centralised procedure.", "categories": "Human", "first_published_date": "03/09/2010", "last_updated_date": "25/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/vaccines-pandemic-influenza" }, { "title": "Accessibility", "summary": "The European Medicines Agency (EMA) is committed to ensuring accessibility of its website to all people, including those with cognitive or physical impairments.", "categories": "Corporate", "first_published_date": "30/06/2025", "last_updated_date": "25/11/2025", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/accessibility" }, { "title": "Antimicrobial resistance in human medicine", "summary": "Combatting the threat of antimicrobial resistance is a high priority for the European Medicines Agency (EMA) and the whole of the European medicines regulatory network. This priority refers particularly to resistance to antibiotics", "categories": "Human", "first_published_date": "30/06/2016", "last_updated_date": "21/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/antimicrobial-resistance/antimicrobial-resistance-human-medicine" }, { "title": "Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2010", "last_updated_date": "21/11/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-epileptic-disorders-scientific-guideline" }, { "title": "Antimicrobial resistance", "summary": "Combatting the threat of antimicrobial resistance is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network.", "categories": "Human;Veterinary", "first_published_date": "21/05/2010", "last_updated_date": "21/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/antimicrobial-resistance" }, { "title": "Search tips", "summary": "These search tips aim to help you use the European Medicines Agency's (EMA) medicine and global sitewide searches more effectively.", "categories": "Corporate", "first_published_date": "18/03/2019", "last_updated_date": "19/11/2025", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/search-tips" }, { "title": "EMA's work on public health emergencies", "summary": "The European Medicines Agency (EMA) has developed a health threats plan describing how it operates during an emerging health threat. The plan sets out the roles and responsibilities of EMA's scientific committees and staff during a public health threat. This enables a rapid and efficient response.", "categories": "Human", "first_published_date": "14/10/2024", "last_updated_date": "18/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/emas-work-public-health-emergencies" }, { "title": "Scientific advice and protocol assistance", "summary": "The European Medicines Agency (EMA) can advise medicine developers on the most appropriate way to generate robust evidence on a medicine's benefits and risks. EMA provides scientific advice to support the timely and sound development of high-quality, effective and safe medicines. This benefits patients.", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "17/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance" }, { "title": "Scientific advice for public health emergencies and threats", "summary": "The European Medicines Agency's (EMA) Emergency Task Force (ETF) provides scientific advice to developers of medicines used in declared or potential public health emergencies and threats.", "categories": "Human", "first_published_date": "17/11/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/emergency-task-force-etf/scientific-advice-public-health-emergencies-threats" }, { "title": "Task Forces", "summary": "The European Medicines Agency (EMA) has three mission-critical task forces which support its human and veterinary medicines divisions, bringing together expertise to drive transformational change in high-priority areas of the Agency's work.", "categories": "Corporate", "first_published_date": "02/03/2020", "last_updated_date": "17/11/2025", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/task-forces" }, { "title": "Incident management plan", "summary": "The European Medicines Agency (EMA) set up the incident management plan for medicines for human use as a framework for the identification and management of incidents within the European medicines regulatory network.", "categories": "Human", "first_published_date": "13/08/2012", "last_updated_date": "14/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/incident-management-plan" }, { "title": "Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "14/11/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-non-food-producing-animal-species-scientific-guideline" }, { "title": "ICH E21 guideline on inclusion of pregnant and breastfeeding individuals in clinical trials – Scientific guideline", "summary": "This International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline aims to provide recommendations for the appropriate inclusion of pregnant and breastfeeding individuals in clinical trials.", "categories": "Human", "first_published_date": "28/05/2025", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/ich-e21-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/09/2025", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-idiopathic-pulmonary-fibrosis-ipf-scientific-guideline" }, { "title": "Development of new medicinal products for the treatment of ulcerative colitis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/01/2008", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/development-new-medicinal-products-treatment-ulcerative-colitis-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the management of Crohn's disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-management-crohns-disease-scientific-guideline" }, { "title": "Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/11/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/non-inferiority-equivalence-comparisons-clinical-trials-scientific-guideline" }, { "title": "Switching between superiority and non-inferiority - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2000", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/switching-between-superiority-non-inferiority-scientific-guideline" }, { "title": "Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "13/11/2025", "general_url": "https://www.ema.europa.eu/en/non-inferiority-equivalence-comparisons-clinical-trials-scientific-guideline-1" }, { "title": "Cancer medicines", "summary": "The European Medicines Agency (EMA) evaluates an increasing number of new cancer medicines. EMA collaborates with the European medicines regulatory network and international regulators to address the unmet needs of cancer patients. This is meant to advance cancer care and alleviate the burden of cancer in the European Union (EU). It is in line with EMA's role to foster scientific excellence in the evaluation and supervision of medicines.", "categories": "Human", "first_published_date": "28/10/2024", "last_updated_date": "07/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines" }, { "title": "Personalised medicine in oncology", "summary": "Personalised medicine in oncology refers to the practice of tailoring medical care to the unique molecular and genetic characteristics of each cancer patient’s tumour. These characteristics are called biomarkers and this practice is also known as precision oncology.", "categories": "Human", "first_published_date": "07/11/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines/personalised-medicine-oncology" }, { "title": "What we do", "summary": "The European Medicines Agency (EMA) fosters scientific excellence in the evaluation and supervision of medicines. This benefits public and animal health in the European Union (EU).", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "06/11/2025", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do" }, { "title": "Guidelines Consistency Group", "summary": "The Guidelines Consistency Group (GCG) provides peer reviews for all concept papers, guidelines, reflection papers and related documents submitted for adoption to the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This is meant to ensure their regulatory and scientific consistency.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "05/11/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/guidelines-consistency-group" }, { "title": "High-risk medical devices", "summary": "Consultation procedures and advice for high-risk medical devices, including information on the panels and how to participate in them.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "04/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/high-risk-medical-devices" }, { "title": "Borderline products", "summary": "Borderline products are complex healthcare products which generate uncertainty over the applicable regulatory framework.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "04/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/borderline-products" }, { "title": "Companion diagnostics ('in vitro diagnostics')", "summary": "Guidance for notified bodies on the procedure for obtaining a scientific opinion from the European Medicines Agency (EMA) on the suitability of companion diagnostics for medicinal products.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "04/11/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/companion-diagnostics-vitro-diagnostics" }, { "title": "Fighting medicine shortages: It takes a team", "summary": "The European Medicines Agency (EMA), together with consumer and healthcare professional organisations, is running the #ItTakesATeam campaign to highlight how different actors work together to help patients during medicine shortages.", "categories": "Human;Veterinary", "first_published_date": "04/11/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/fighting-medicine-shortages-it-takes-team" }, { "title": "Clinical Trials Information System", "summary": "The Clinical Trials Information System (CTIS) supports the flow of information between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) countries and the European Commission. CTIS went live with a searchable public website on 31 January 2022.", "categories": "Human", "first_published_date": "31/01/2022", "last_updated_date": "29/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system" }, { "title": "What we publish on medicines and when", "summary": "The European Medicines Agency (EMA) publishes information on human medicines at various stages of their life cycle", "categories": "Human;Veterinary;Herbal", "first_published_date": "10/06/2020", "last_updated_date": "29/10/2025", "general_url": "https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when" }, { "title": "Advanced therapy classification", "summary": "Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). The procedure allows them to receive confirmation that a medicine - which is based on genes, cells or tissues - meets the scientific criteria for defining an ATMP.", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "28/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation/advanced-therapy-classification" }, { "title": "Substance, product, organisation and referential (SPOR) master data", "summary": "The European Medicines Agency (EMA) is delivering four data management services for centralised management of master data: substance, product, organisation and referential (SPOR). They comply with standards set by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). These standards make it easier to exchange of medicine information in a reliable manner.", "categories": "Human;Veterinary", "first_published_date": "02/06/2015", "last_updated_date": "27/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data" }, { "title": "Quality aspects of phage therapy medicinal products", "summary": "", "categories": "Human", "first_published_date": "22/12/2023", "last_updated_date": "24/10/2025", "general_url": "https://www.ema.europa.eu/en/quality-aspects-phage-therapy-medicinal-products" }, { "title": "Non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/non-human-primates-safety-testing-human-medicinal-products-opportunities-3rs-implementation-scientific-guideline" }, { "title": "Press and social media", "summary": "The European Medicines Agency's (EMA) press office deals with enquiries from media on matters relating to our work. EMA also manages a number of social media platforms. This enables us to raise awareness about our work on public and animal health and to update users on latest developments.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "21/10/2025", "general_url": "https://www.ema.europa.eu/en/news-events/press-social-media" }, { "title": "Frequently asked questions about parallel distribution", "summary": "", "categories": "Human", "first_published_date": "03/05/2013", "last_updated_date": "15/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/parallel-distribution/frequently-asked-questions-about-parallel-distribution" }, { "title": "Interoperability assessment at EMA", "summary": "The European Medicines Agency (EMA) is making interoperability assessment reports available in compliance with the Interoperable Europe Act. This legislation is a cooperation framework for public administrations across the European Union (EU). It aims to build a secure cross-border exchange of data and adopt shared digital solutions such as open-source software and IT tools.", "categories": "Corporate", "first_published_date": "10/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/interoperability-assessment-ema" }, { "title": "Mutual recognition agreements (MRA)", "summary": "The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.", "categories": "Human;Veterinary", "first_published_date": "19/07/2017", "last_updated_date": "10/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/mutual-recognition-agreements-mra" }, { "title": "ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines - Scientific guideline", "summary": "This guideline recommends international standards for, and promotes harmonization of, the general principles on planning, designing, analysing, and reporting of noninterventional studies that utilize fit-for-use data for safety assessment of medicines", "categories": "Human", "first_published_date": "30/05/2024", "last_updated_date": "10/10/2025", "general_url": "https://www.ema.europa.eu/en/ich-m14-guideline-general-principles-plan-design-analysis-pharmacoepidemiological-studies-utilize-real-world-data-safety-assessment-medicines-scientific-guideline" }, { "title": "PDCO: Working parties and other groups", "summary": "The Paediatric Committee (PDCO) consults its working parties and other groups on scientific issues relating to their particular field of expertise, in the review process of paediatric investigation plans and when drafting or revising scientific guidance documents.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/pdco-working-parties-other-groups" }, { "title": "HMPC: Working parties and other groups", "summary": "The Committee on Herbal Medicinal Products (HMPC) consults its working parties and other groups on scientific issues relating to their particular field of expertise, and delegates certain tasks to them associated with the scientific evaluation of applications or drafting and revision of scientific guidance documents.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/hmpc-working-parties-other-groups" }, { "title": "COMP: Working parties and other groups", "summary": "The Committee for Orphan Medicinal Products (COMP) consults its working parties and other groups on scientific issues relating to their particular field of expertise, and delegates certain tasks to them associated with the scientific evaluation of applications or drafting and revision of scientific guidance documents.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/comp-working-parties-other-groups" }, { "title": "CAT: Working parties and other groups", "summary": "The Committee for Advanced Therapies (CAT) consults its working parties and other groups on scientific issues relating to their particular field of expertise, and delegates certain tasks to them associated with the scientific evaluation of applications or drafting and revision of scientific guidance documents.", "categories": "", "first_published_date": "22/09/2010", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cat-working-parties-other-groups" }, { "title": "CVMP: Working parties and other groups", "summary": "The Committee for Veterinary Medicinal Products (CVMP) establishes a number of working parties at the beginning of each three-year mandate. These working parties have expertise in a particular scientific field, and are composed of members selected from the list of European experts maintained by the Agency.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp-working-parties-other-groups" }, { "title": "CHMP: Working parties and other groups", "summary": "The Committee for Medicinal Products for Human Use (CHMP) establishes a number of working parties at the beginning of each three-year mandate. Most working parties operate under the governance of a domain. These working parties have expertise in a particular scientific field, and are composed of members selected from the list of European experts maintained by the Agency.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups" }, { "title": "Business hours and holidays", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "06/10/2025", "general_url": "https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/business-hours-holidays" }, { "title": "PRAC: Working parties and other groups of interest", "summary": "The Pharmacovigilance Risk Assessment Committee (PRAC) consults its working parties and other groups on scientific and regulatory issues when needed. It also delegates specific tasks to them, such as pharmacovigilance activities or drafting scientific guidance. These groups provide specialised expertise in their respective fields.", "categories": "Human", "first_published_date": "03/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/prac-working-parties-other-groups-interest" }, { "title": "PRAC Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact)", "summary": "The Pharmacovigilance Risk Assessment Committee (PRAC) Interest Group on Measuring the Impact of Pharmacovigilance Activities (PRAC IG Impact) oversees the implementation of the PRAC impact strategy.", "categories": "", "first_published_date": "03/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/prac-working-parties-other-groups-interest/prac-interest-group-measuring-impact-pharmacovigilance-activities-prac-ig-impact" }, { "title": "Granularity and Periodicity Advisory Group", "summary": "The Granularity and Periodicity Advisory Group (GPAG) provides advice to the Pharmacovigilance Risk Assessment Committee (PRAC) relating to amendments of the European Union Reference Dates (EURD) list.", "categories": "Human", "first_published_date": "03/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/prac-working-parties-other-groups-interest/granularity-periodicity-advisory-group" }, { "title": "PRAC Risk Minimisation Alliance (PRISMA) Group", "summary": "The Pharmacovigilance Risk Assessment Committee (PRAC) Risk Minimisation Alliance (PRISMA) group advises PRAC on factors that support the effective implementation of risk minimisation measures in healthcare.", "categories": "", "first_published_date": "03/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/prac-working-parties-other-groups-interest/prac-risk-minimisation-alliance-prisma-group" }, { "title": "Data in regulation: Big data and other sources", "summary": "The European Medicines Agency (EMA) bases its regulatory decisions on different types of data. These include ‘big data’ sources like real-world evidence obtained from electronic health records and patient registries. EMA uses rigorous and transparent analytics, such as advanced artificial intelligence-driven methods, to generate insights and evidence that support decisions on the safety, efficacy, and quality of medicines.", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/02/2019", "last_updated_date": "03/10/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources" }, { "title": "VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/11/2014", "last_updated_date": "02/10/2025", "general_url": "https://www.ema.europa.eu/en/vich-gl23-studies-evaluate-safety-residues-veterinary-drugs-human-food-genotoxicity-testing-scientific-guideline" }, { "title": "VICH GL22 Safety studies for veterinary drug residues in human food: reproduction studies - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/06/2004", "last_updated_date": "02/10/2025", "general_url": "https://www.ema.europa.eu/en/vich-gl22-safety-studies-veterinary-drug-residues-human-food-reproduction-studies-scientific-guideline" }, { "title": "VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs) St4", "summary": "", "categories": "Veterinary", "first_published_date": "02/10/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/vich-gl62-target-animal-safety-veterinary-monoclonal-antibody-products-vmaps-st4" }, { "title": "Fees payable to the European Medicines Agency", "summary": "The European Medicines Agency (EMA) charges fees for the services it provides. As of 1 January 2025, EMA's fees are governed by Regulation (EU) 2024/568. This is known as the 'New fee regulation'. EMA makes regulatory guidance on the new fee regulation available on this website, in the form of questions and answers.", "categories": "Human;Veterinary;Corporate", "first_published_date": "24/03/2011", "last_updated_date": "02/10/2025", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency" }, { "title": "Paediatric clinical trials", "summary": "The European Medicines Agency (EMA) makes information on clinical trials in children available through the Clinical Trials Information System (CTIS) and the European Union Clinical Trials Register (EU CTR). EMA manages these two websites.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "01/10/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-clinical-trials" }, { "title": "In-use stability testing of veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/02/2002", "last_updated_date": "01/10/2025", "general_url": "https://www.ema.europa.eu/en/use-stability-testing-veterinary-medicinal-products-scientific-guideline" }, { "title": "Clinical evaluation of medicinal products intended for treatment of hepatitis B - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/02/2006", "last_updated_date": "30/09/2025", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-medicinal-products-intended-treatment-hepatitis-b-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of psoriatic arthritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/12/2006", "last_updated_date": "30/09/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-psoriatic-arthritis-scientific-guideline" }, { "title": "Patients' and Consumers' Working Party", "summary": "The Patients' and Consumers' Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers.", "categories": "Human", "first_published_date": "15/02/2016", "last_updated_date": "29/09/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/comp-working-parties-other-groups/patients-consumers-working-party" }, { "title": "Innovation Task Force briefing meetings", "summary": "The Innovation Task Force (ITF) briefing meetings offer developers early dialogue with the European Medicines Agency (EMA) on innovative medicines. They address regulatory, technical and scientific concerns.", "categories": "Human;Veterinary", "first_published_date": "18/03/2025", "last_updated_date": "25/09/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/innovation-task-force-briefing-meetings" }, { "title": "Medicine Shortages Single Point of Contact (SPOC) Working Party", "summary": "The Medicine Shortages Single Point of Contact (SPOC) Working Party is responsible for monitoring and reporting events that could affect the supply of medicines in the European Union (EU).", "categories": "Human", "first_published_date": "28/09/2023", "last_updated_date": "25/09/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party" }, { "title": "Guidance on the application of the revised variations framework", "summary": "", "categories": "Human", "first_published_date": "31/10/2024", "last_updated_date": "22/09/2025", "general_url": "https://www.ema.europa.eu/en/guidance-application-revised-variations-framework" }, { "title": "The procedure to be followed when a batch of a vaccine finished product is suspected to be contaminated with bovine viral diarrhoea virus - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2015", "last_updated_date": "19/09/2025", "general_url": "https://www.ema.europa.eu/en/procedure-be-followed-when-batch-vaccine-finished-product-suspected-be-contaminated-bovine-viral-diarrhoea-virus-scientific-guideline" }, { "title": "Duration of immunity achieved by veterinary vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/10/2000", "last_updated_date": "19/09/2025", "general_url": "https://www.ema.europa.eu/en/duration-immunity-achieved-veterinary-vaccines-scientific-guideline" }, { "title": "Worksharing of variations (veterinary medicines)", "summary": "The worksharing procedure enables marketing authorisation holders for veterinary medicines to combine the same variations affecting different medicines into a single application, irrespective of the authorisation route of the medicines. Guidance is available from the European Medicines Agency (EMA) on this procedure in the form of questions and answers.", "categories": "Veterinary", "first_published_date": "20/01/2022", "last_updated_date": "17/09/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/worksharing-variations-veterinary-medicines" }, { "title": "Mpox", "summary": "The European Medicines Agency (EMA) is monitoring the evolution and spread of mpox disease. When required, EMA is prepared to take special measures to ensure availability of critical medicines, devices and vaccines, in close cooperation with its partners in the European medicines regulatory network and at international level. These measures can include recommendations on medicines against mpox to help national authorities tackle infections.", "categories": "Human", "first_published_date": "28/06/2022", "last_updated_date": "16/09/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/mpox" }, { "title": "World Health Organization (WHO)", "summary": "The European Medicines Agency (EMA) works together with the World Health Organization (WHO) on a wide range of initiatives related to medicine regulatory topics, scientific assessment of medicines and capacity building to advance global public health.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "01/09/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/world-health-organization-who" }, { "title": "Transfer of data on suspected adverse reactions to WHO", "summary": "As of 2017, EMA operates a regular transfer of data on suspected adverse drug reactions occurring in the European Union (EU) to the World Health Organization (WHO)'s Uppsala Monitoring Centre.", "categories": "Corporate", "first_published_date": "01/09/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/world-health-organization-who/transfer-data-suspected-adverse-reactions-who" }, { "title": "Industry Standing Group meetings", "summary": "The European Medicine Agency's (EMA) Industry Standing Group (ISG) meets four times per year to enable an exchange of views between the Agency and stakeholders in the pharmaceutical and medical device industries. The group also facilitates implementation of new legislative proposals.", "categories": "Human", "first_published_date": "21/09/2023", "last_updated_date": "01/09/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry/industry-standing-group/industry-standing-group-meetings" }, { "title": "Administration and Corporate Management", "summary": "", "categories": "Corporate", "first_published_date": "29/02/2012", "last_updated_date": "01/09/2025", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/administration-corporate-management" }, { "title": "Companion Diagnostic (CDx) Expert Group", "summary": "The European Medicines Agency's (EMA) expert group on companion diagnostics advises the EMA's Committee for Medicinal Products for Human Use (CHMP) on procedures and relevant scientific issues.", "categories": "", "first_published_date": "28/08/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/companion-diagnostic-cdx-expert-group" }, { "title": "Novel therapies", "summary": "The Novel Therapies and Technologies Working Party (NTWP) of the European Medicines Agency's (EMA) Committee for Medicinal Products for Veterinary Use prepares scientific guidance on the requirements for authorisation of novel therapy veterinary medicines.", "categories": "Veterinary", "first_published_date": "26/02/2016", "last_updated_date": "28/08/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory/research-development/scientific-guidelines/novel-therapies" }, { "title": "Assessment templates and guidance", "summary": "The European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) and Committee on Advanced Therapies (CAT) should use the assessment report templates and documents listed on this page for the assessment of any new application in the centralised procedure.", "categories": "Human", "first_published_date": "12/10/2011", "last_updated_date": "26/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/assessment-templates-guidance" }, { "title": "Clinical Trials Regulation", "summary": "European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation entered into application on 31 January 2022. It aims to ensure the EU offers an attractive and favourable environment for carrying out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants.", "categories": "Human", "first_published_date": "21/01/2015", "last_updated_date": "26/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation" }, { "title": "Development of the Clinical Trials Information System", "summary": "The European Union (EU) Member States and European Economic Area (EEA) countries, European Commission and European Medicines Agency (EMA) launched the Clinical Trials Information System (CTIS) on 31 January 2022. ", "categories": "Human", "first_published_date": "31/01/2022", "last_updated_date": "26/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system/development-clinical-trials-information-system" }, { "title": "Clinical Trials Regulation: progress on implementation", "summary": "Under the Accelerating Clinical Trials EU (ACT EU) initiative, the European medicines regulatory network regularly publishes statistics on the authorisation of clinical trials in the European Union (EU) and European Economic Area (EEA). This information provides an insight into how the Clinical Trials Regulation is transforming the clinical-trial environment in the EU / EEA.", "categories": "Human", "first_published_date": "20/05/2022", "last_updated_date": "26/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-regulation/clinical-trials-regulation-progress-implementation" }, { "title": "Veterinary Medicines", "summary": "The European Medicines Agency's (EMA) Veterinary Medicines Division oversees veterinary medicines throughout their lifecycle. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. It also works to facilitate access to and the optimal use of veterinary medicines, for the benefit of animal welfare, animal health and public health in the European Union.", "categories": "Veterinary;Corporate", "first_published_date": "29/02/2012", "last_updated_date": "18/08/2025", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/veterinary-medicines" }, { "title": "Everolimus product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "14/08/2025", "general_url": "https://www.ema.europa.eu/en/everolimus-product-specific-bioequivalence-guidance" }, { "title": "Deferasirox product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "18/12/2020", "last_updated_date": "14/08/2025", "general_url": "https://www.ema.europa.eu/en/deferasirox-product-specific-bioequivalence-guidance" }, { "title": "Good agricultural and collection practice for starting materials of herbal origin - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "20/02/2006", "last_updated_date": "12/08/2025", "general_url": "https://www.ema.europa.eu/en/good-agricultural-collection-practice-starting-materials-herbal-origin-scientific-guideline" }, { "title": "Paediatric medicines: applications and procedures", "summary": "Advice for applicants for paediatric medicines, including information on how to submit their applications, what templates and forms to use, the deadlines they need to meet, and the contact points they can reach out to.", "categories": "Human", "first_published_date": "03/06/2024", "last_updated_date": "08/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-medicines-applications-procedures" }, { "title": "Vaccine Monitoring Platform", "summary": "The Vaccine Monitoring Platform (VMP) is a collaboration between the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) aiming to generate real-word evidence (RWE) on the safety, effectiveness and use of vaccines in the European Union (EU) and the European Economic Area (EEA).", "categories": "Human", "first_published_date": "27/09/2023", "last_updated_date": "07/08/2025", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/vaccine-monitoring-platform" }, { "title": "Quality guidelines", "summary": "The European Medicines Agency's scientific guidelines on the quality of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "06/08/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines" }, { "title": "Clinical investigation of medicines for the treatment of Alzheimer's disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "06/08/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicines-treatment-alzheimers-disease-scientific-guideline" }, { "title": "ICH E6 Good clinical practice - Scientific guideline", "summary": "The ICH guideline for good clinical practice (GCP) establishes an international standard for the design, conduct, recording, and reporting of clinical trials involving human participants. It outlines the responsibilities of sponsors, investigators, and other stakeholders to protect the rights, safety, and well-being of trial participants, while ensuring the integrity and credibility of clinical trial data. \r\n\r\nThe guideline provides a unified framework to facilitate the mutual acceptance of clinical trial results by regulatory authorities across ICH member regions, supporting global collaboration in drug development and ensuring consistent regulatory standards.​", "categories": "Human", "first_published_date": "01/07/2002", "last_updated_date": "31/07/2025", "general_url": "https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline" }, { "title": "Paediatric-use marketing authorisations", "summary": "The paediatric-use marketing authorisation (PUMA) is a dedicated marketing authorisation covering the indication(s) and appropriate formulation(s) for medicines developed exclusively for use in the paediatric population.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "31/07/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/paediatric-medicines-marketing-authorisation/paediatric-use-marketing-authorisations" }, { "title": "Cholic acid product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "31/01/2018", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/cholic-acid-product-specific-bioequivalence-guidance" }, { "title": "Dabrafenib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/dabrafenib-product-specific-bioequivalence-guidance" }, { "title": "Azacitidine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/azacitidine-product-specific-bioequivalence-guidance" }, { "title": "Aprepitant product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/aprepitant-product-specific-bioequivalence-guidance" }, { "title": "Vortioxetine hydrobromide / vortioxetine lactate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/vortioxetine-hydrobromide-vortioxetine-lactate-product-specific-bioequivalence-guidance" }, { "title": "Zonisamide product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "25/05/2015", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/zonisamide-product-specific-bioequivalence-guidance" }, { "title": "Paclitaxel product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/paclitaxel-product-specific-bioequivalence-guidance" }, { "title": "Emtricitabine/tenofovir disoproxil product-specific bioequivalence guidance", "summary": "", "categories": "", "first_published_date": "10/04/2015", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/emtricitabine-tenofovir-disoproxil-product-specific-bioequivalence-guidance" }, { "title": "Colchicine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "08/03/2019", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/colchicine-product-specific-bioequivalence-guidance" }, { "title": "Ticagrelor product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/ticagrelor-product-specific-bioequivalence-guidance" }, { "title": "Emtricitabine / rilpivirine / tenofovir disoproxil product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/emtricitabine-rilpivirine-tenofovir-disoproxil-product-specific-bioequivalence-guidance" }, { "title": "Rilpivirine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "28/07/2017", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/rilpivirine-product-specific-bioequivalence-guidance" }, { "title": "Rivaroxaban product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/rivaroxaban-product-specific-bioequivalence-guidance" }, { "title": "Sitagliptin product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2015", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/sitagliptin-product-specific-bioequivalence-guidance" }, { "title": "Tacrolimus granules product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "30/07/2025", "general_url": "https://www.ema.europa.eu/en/tacrolimus-granules-product-specific-bioequivalence-guidance" }, { "title": "Fingolimod product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "29/07/2025", "general_url": "https://www.ema.europa.eu/en/fingolimod-product-specific-bioequivalence-guidance" }, { "title": "Entecavir product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "29/07/2025", "general_url": "https://www.ema.europa.eu/en/entecavir-product-specific-bioequivalence-guidance" }, { "title": "Reporting safety information on clinical trials", "summary": "Clinical trial sponsors must report information on the safety of clinical trial participants to the European Union (EU) Member States and European Economic Area (EEA) countries throughout the lifecycle of a clinical trial. Guidance is available from the European Medicines Agency (EMA) to help clinical trial sponsors comply with their reporting obligations.", "categories": "", "first_published_date": "25/03/2023", "last_updated_date": "29/07/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/reporting-safety-information-clinical-trials" }, { "title": "Nitrosamine impurities", "summary": "The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines. EMA has also provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities.  ", "categories": "Human", "first_published_date": "28/10/2019", "last_updated_date": "29/07/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities" }, { "title": "ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/04/2025", "last_updated_date": "25/07/2025", "general_url": "https://www.ema.europa.eu/en/ich-guideline-m13b-bioequivalence-immediate-release-solid-oral-dosage-forms-additional-strengths-biowaiver-scientific-guideline" }, { "title": "Signal management", "summary": "A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. The European Medicines Agency (EMA), together with the regulatory authorities in the Member States and marketing authorisation holders are responsible for detecting and managing safety signals.", "categories": "Human", "first_published_date": "04/10/2013", "last_updated_date": "25/07/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management" }, { "title": "Development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/02/2024", "last_updated_date": "25/07/2025", "general_url": "https://www.ema.europa.eu/en/development-reflection-paper-use-external-controls-evidence-generation-regulatory-decision-making-scientific-guideline" }, { "title": "Demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/11/1992", "last_updated_date": "25/07/2025", "general_url": "https://www.ema.europa.eu/en/demonstration-efficacy-veterinary-medicinal-products-containing-anticoccidial-substances-scientific-guideline" }, { "title": "Risk minimisation measures (RMM)", "summary": "A risk minimisation measure (RMM) is intended to reduce adverse reactions of medicines, also called side effects. These measures and the risks they address feature in the product information of medicines authorised in the European Union (EU). Where needed, these measures may also feature in additional resources. The European Medicines Agency (EMA) makes information on risk minimisation measures available on this website, while providing links to additional resources.", "categories": "", "first_published_date": "24/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/risk-minimisation-measures-rmm" }, { "title": "Safety and residue data requirements for the establishment of maximum residue limits in minor species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2021", "last_updated_date": "24/07/2025", "general_url": "https://www.ema.europa.eu/en/safety-residue-data-requirements-establishment-maximum-residue-limits-minor-species-scientific-guideline" }, { "title": "Requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/01/2009", "last_updated_date": "21/07/2025", "general_url": "https://www.ema.europa.eu/en/requirements-demonstrating-therapeutic-equivalence-between-orally-inhaled-products-oip-asthma-chronic-obstructive-pulmonary-disease-copd-scientific-guideline" }, { "title": "30th anniversary scientific conference highlights", "summary": "The European Medicines Agency (EMA) marked its 30th anniversary on 25 June 2025 with a scientific conference entitled ‘Medicines, regulation and the future.’", "categories": "Corporate", "first_published_date": "21/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/30th-anniversary-scientific-conference-highlights" }, { "title": "Regulatory science research needs", "summary": "The European Medicines Agency (EMA) has identified topics where research is needed to address knowledge gaps in regulatory science. Research in these areas can support medicine development and evaluation, ultimately helping patients in the European Union (EU) access innovative medicines that address their needs.", "categories": "Human;Veterinary", "first_published_date": "15/12/2021", "last_updated_date": "18/07/2025", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/regulatory-science-research-needs" }, { "title": "Sharing data across systems: Master data on human medicines", "summary": "The European Medicines Agency (EMA) and the Heads of Medicine Agencies (HMA) are working together to build a shared centralised repository of product information on human medicines marketed in the European Union (EU). This concept is based on master data, which enable data sharing across systems.", "categories": "Human", "first_published_date": "10/07/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/sharing-data-across-systems-master-data-human-medicines" }, { "title": "Dronedarone product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "28/07/2017", "last_updated_date": "10/07/2025", "general_url": "https://www.ema.europa.eu/en/dronedarone-product-specific-bioequivalence-guidance" }, { "title": "Sirolimus product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/07/2015", "last_updated_date": "10/07/2025", "general_url": "https://www.ema.europa.eu/en/sirolimus-product-specific-bioequivalence-guidance" }, { "title": "Clinical Trials Information System (CTIS): online training modules for authorities", "summary": "The European Medicines Agency (EMA) provides an online modular training programme to help national competent authorities, ethics committees and the European Commission use the Clinical Trials Information System (CTIS). The programme contains modules and audience-targeted materials covering the applicable clinical trial lifecycle stages. ", "categories": "Human", "first_published_date": "09/02/2021", "last_updated_date": "09/07/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/clinical-trials-information-system-ctis-training-support/clinical-trials-information-system-ctis-online-training-modules-authorities" }, { "title": "EudraVigilance Veterinary", "summary": "EudraVigilance is the data-processing network and database for managing and analysing information on suspected adverse reactions to medicines which have been authorised in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "03/07/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/eudravigilance-veterinary" }, { "title": "Healthcare professionals: Key documents", "summary": "The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with healthcare professionals.", "categories": "Human", "first_published_date": "29/02/2012", "last_updated_date": "02/07/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/healthcare-professionals/healthcare-professionals-key-documents" }, { "title": "QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures", "summary": "", "categories": "Veterinary", "first_published_date": "25/11/2016", "last_updated_date": "01/07/2025", "general_url": "https://www.ema.europa.eu/en/qrd-guidance-use-adopted-abbreviations-pictograms-packaging-veterinary-medicinal-products-authorised-centralised-cp-mutual-recognition-mrp-decentralised-dcp-subsequent-recognition-srp-national" }, { "title": "Ibuprofen product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "03/08/2017", "last_updated_date": "01/07/2025", "general_url": "https://www.ema.europa.eu/en/ibuprofen-product-specific-bioequivalence-guidance" }, { "title": "Dolutegravir product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "28/07/2017", "last_updated_date": "01/07/2025", "general_url": "https://www.ema.europa.eu/en/dolutegravir-product-specific-bioequivalence-guidance" }, { "title": "Levothyroxine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "15/06/2020", "last_updated_date": "01/07/2025", "general_url": "https://www.ema.europa.eu/en/levothyroxine-product-specific-bioequivalence-guidance" }, { "title": "Transparency: exceptional measures for COVID-19 medicines", "summary": "The European Medicines Agency (EMA) has implemented exceptional measures to maximise the transparency of its regulatory activities on COVID-19 medicines, during and after the COVID-19 public health emergency. These measures have supported public health efforts, fostered trust and enabled informed decision-making.", "categories": "Human", "first_published_date": "19/10/2020", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparency-exceptional-measures-covid-19-medicines" }, { "title": "Ursodeoxycholic acid product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/12/2021", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/ursodeoxycholic-acid-product-specific-bioequivalence-guidance" }, { "title": "Prasugrel product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/prasugrel-product-specific-bioequivalence-guidance" }, { "title": "About this website", "summary": "The European Medicines Agency's (EMA) corporate website is EMA's main communication channel. Information in this section helps you get the most out of its special features such as the search and glossaries of medical and regulatory terms.", "categories": "Corporate", "first_published_date": "15/06/2021", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/about-website" }, { "title": "Paracetamol product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "28/07/2017", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/paracetamol-product-specific-bioequivalence-guidance" }, { "title": "Oseltamivir product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/oseltamivir-product-specific-bioequivalence-guidance" }, { "title": "Metformin product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/06/2023", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/metformin-product-specific-bioequivalence-guidance" }, { "title": "Dabigatran etexilate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/dabigatran-etexilate-product-specific-bioequivalence-guidance" }, { "title": "Memantine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/04/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/memantine-product-specific-bioequivalence-guidance" }, { "title": "Posaconazole product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/posaconazole-product-specific-bioequivalence-guidance" }, { "title": "Lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects", "summary": "", "categories": "Human", "first_published_date": "30/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/lessons-learned-covid-19-pandemic-scientific-considerations-non-clinical-aspects" }, { "title": "Lurasidone product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/06/2023", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/lurasidone-product-specific-bioequivalence-guidance" }, { "title": "Apixaban product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/06/2018", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/apixaban-product-specific-bioequivalence-guidance" }, { "title": "Acenocoumarol product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "09/11/2020", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/acenocoumarol-product-specific-bioequivalence-guidance" }, { "title": "Voriconazole product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/07/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/voriconazole-product-specific-bioequivalence-guidance" }, { "title": "Tadalafil product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/06/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/tadalafil-product-specific-bioequivalence-guidance" }, { "title": "Repaglinide product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/repaglinide-product-specific-bioequivalence-guidance" }, { "title": "Requesting scientific advice or protocol assistance from EMA", "summary": "The European Medicines Agency (EMA) provides scientific advice to medicine developers, to support the timely and sound development of high-quality, effective and safe medicines. Applicants wishing to apply should follow the guidance in this section.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "30/06/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/requesting-scientific-advice-or-protocol-assistance-ema" }, { "title": "Newsletter archive", "summary": "Archive of the European Medicines Agency (EMA)'s discontinued newsletters", "categories": "Human;Veterinary", "first_published_date": "04/07/2011", "last_updated_date": "26/06/2025", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/newsletters/newsletter-archive" }, { "title": "Regulatory science research", "summary": "The European Medicines Agency (EMA) plays an important role in the innovation and availability of medicines for human and veterinary use. It does so by supporting to research activities within the European Union (EU) and beyond. EMA also contributes to scientific debate by providing experience and expertise related to medicine development and medicine safety.", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/03/2013", "last_updated_date": "25/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research" }, { "title": "European Platform for Regulatory Science Research", "summary": "The European Platform for Regulatory Science Research brings together academia and regulators to advance research in regulatory science. Research in this field enhances the development and evaluation of medicines. It enables faster patient access to safe, effective, and high-quality medicines.", "categories": "Human;Veterinary", "first_published_date": "25/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/european-platform-regulatory-science-research" }, { "title": "Developing cancer medicines for children", "summary": "The European Medicines Agency (EMA) plays a central role in supporting research and development of innovative cancer medicines for children. We work together with international partners to advance treatment for childhood cancers.", "categories": "Human", "first_published_date": "25/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/developing-cancer-medicines-children" }, { "title": "Quality aspects of pharmaceutical veterinary medicines for administration via drinking water - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/04/2005", "last_updated_date": "20/06/2025", "general_url": "https://www.ema.europa.eu/en/quality-aspects-pharmaceutical-veterinary-medicines-administration-drinking-water-scientific-guideline" }, { "title": "Methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/methodology-environmental-risk-assessment-ectoparasiticidal-vmps-cats-dogs-scientific-guideline" }, { "title": "How we work", "summary": "To fulfill its mission, the European Medicines Agency (EMA) works closely with national competent authorities in a regulatory network. The Agency also implements policies and procedures to ensure it works independently, openly and transparently and upholds the highest standards in its scientific recommendations.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "19/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work" }, { "title": "Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis", "summary": "", "categories": "Human", "first_published_date": "18/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-new-reflection-paper-clinical-investigation-medicinal-products-treatment-systemic-sclerosis" }, { "title": "Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline", "summary": "This reflection paper discusses methodological aspects of non-interventional studies (NIS) using real-world data (RWD) in order to generate real-world evidence (RWE) for regulatory purposes.", "categories": "Human", "first_published_date": "03/05/2024", "last_updated_date": "17/06/2025", "general_url": "https://www.ema.europa.eu/en/reflection-paper-use-real-world-data-non-interventional-studies-generate-real-world-evidence-scientific-guideline" }, { "title": "Anti-fraud strategy", "summary": "The European Medicines Agency (EMA) is committed to ensuring the highest standards of honesty, propriety and integrity in its work. This applies to all our staff, members of committees and external contractors. We have a 'zero tolerance' approach to fraud. Our anti-fraud strategy is central to keeping this commitment.", "categories": "Corporate", "first_published_date": "08/12/2015", "last_updated_date": "17/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/anti-fraud-strategy" }, { "title": "Standard for exchange of non-clinical data (SEND): proof-of-concept study", "summary": "The European Medicines Agency (EMA) makes a Standard for Exchange of Non-clinical Data (SEND datasets) format available to marketing authorisation holders. The SEND proof-of-concept study provides the option to voluntarily submit non-clinical data as part of an initial centralised marketing authorisation.", "categories": "Human", "first_published_date": "16/06/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/standard-exchange-non-clinical-data-send-proof-concept-study" }, { "title": "Annual reports and work programmes", "summary": "The European Medicines Agency (EMA) publishes a full work programme and annual report, to provide an overview of the work of the Agency together with the European medicines regulatory network.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "10/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/annual-reports-work-programmes" }, { "title": "Healthcare professionals", "summary": "The European Medicines Agency (EMA) has been interacting with European healthcare professionals in various areas of its work since it was founded in 1995.", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "03/06/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/healthcare-professionals" }, { "title": "Class waivers", "summary": "The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the adult population.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "03/06/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/class-waivers" }, { "title": "Guidance documents", "summary": "This page lists the European Medicines Agency's general guidance documents relating to veterinary medicines", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "02/06/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/guidance-documents" }, { "title": "Advisory functions", "summary": "The European Medicines Agency has advisory functions and support services that support the Executive Director and the Agency on a range of operational, policy and scientific issues in their various fields of expertise.", "categories": "Corporate", "first_published_date": "16/09/2013", "last_updated_date": "02/06/2025", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/advisory-functions" }, { "title": "Nitrosamine impurities: guidance for marketing authorisation holders", "summary": "The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture and storage of human medicines. EMA has also provided guidance to marketing authorisation holders to avoid or minimise the presence of nitrosamine impurities. ", "categories": "Human", "first_published_date": "19/11/2024", "last_updated_date": "28/05/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities/nitrosamine-impurities-guidance-marketing-authorisation-holders" }, { "title": "COVID-19 medicines", "summary": "The European Medicines Agency (EMA) evaluates and recommends the authorisation of medicines marketed in the European Union (EU). This includes COVID-19 vaccines and treatments. Although COVID-19 in no longer defined as a public health emergency of international concern, EMA continues to monitor the safety of COVID-19 medicines.", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "26/05/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines" }, { "title": "ICH M12 on drug interaction studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/07/2022", "last_updated_date": "23/05/2025", "general_url": "https://www.ema.europa.eu/en/ich-m12-drug-interaction-studies-scientific-guideline" }, { "title": "ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/10/2022", "last_updated_date": "23/05/2025", "general_url": "https://www.ema.europa.eu/en/ich-m11-guideline-clinical-study-protocol-template-technical-specifications-scientific-guideline" }, { "title": "Consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/05/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/consumer-safety-active-substances-immunological-veterinary-medicinal-products-acting-against-endogenous-targets-scientific-guideline" }, { "title": "Careers", "summary": "A career at the European Medicines Agency (EMA) offers candidates interesting and challenging work that brings value to European citizens and a diverse and stimulating working environment, while enjoying attractive benefits and a healthy work-life balance.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "08/05/2025", "general_url": "https://www.ema.europa.eu/en/about-us/careers" }, { "title": "Who we are", "summary": "The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "08/05/2025", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are" }, { "title": "Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing", "summary": "New approach methodologies (NAMs) refer to novel methods that are compliant with the so-called 3Rs principles for the ethical use of animals in medicine testing across the European Union (EU). '3Rs' stands for replacement, reduction and refinement of animal use. The European Medicines Agency (EMA) supports the regulatory acceptance of these new approach methodologies. This ensures NAMs are scientifically sound and can be used in regulatory decision-making.", "categories": "Human;Veterinary", "first_published_date": "02/05/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/ethical-use-animals-medicine-testing/regulatory-acceptance-new-approach-methodologies-nams-reduce-animal-use-testing" }, { "title": "ICH Q1 guideline on stability testing of drug substances and drug products", "summary": "", "categories": "Human", "first_published_date": "30/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/ich-q1-guideline-stability-testing-drug-substances-drug-products" }, { "title": "Industry annual bilateral meetings", "summary": "The European Medicines Agency (EMA) organises annual bilateral meetings with pharmaceutical industry associations. The purpose of the meetings is to exchange views and promote dialogue on high level and strategic topics of common interest.", "categories": "Human", "first_published_date": "21/09/2023", "last_updated_date": "29/04/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry/industry-annual-bilateral-meetings" }, { "title": "Measles", "summary": "Measles is a highly contagious viral infection that can lead to severe complications and even death in rare cases. Children under 5 years of age are particularly at risk. Measles vaccination has had the biggest impact on reducing child mortality and illness over the past 50 years. The European Medicines Agency (EMA) evaluates, recommends and monitors vaccines against diseases such as measles in the European Union (EU).", "categories": "Human", "first_published_date": "28/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/vaccine-preventable-diseases-key-facts/measles" }, { "title": "Policies and procedures", "summary": "The European Medicines Agency's (EMA) policies and procedures ensure that our long-term vision and goals are translated into concrete steps. They set the boundaries for all major EMA decisions and actions.", "categories": "Corporate", "first_published_date": "06/09/2012", "last_updated_date": "22/04/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/policies-procedures" }, { "title": "Committee management", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committee-management" }, { "title": "Expert management", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/expert-management" }, { "title": "Inspection coordination", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/inspection-coordination" }, { "title": "Marketing authorisation", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/marketing-authorisation" }, { "title": "PSUSA and other related post-authorisation processes", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/psusa-other-related-post-authorisation-processes" }, { "title": "Scientific meeting management", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/scientific-meeting-management" }, { "title": "Orphan status management", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/orphan-status-management" }, { "title": "Paediatrics medicines development", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/paediatrics-medicines-development" }, { "title": "Pharmacovigilance", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/pharmacovigilance" }, { "title": "Medical devices", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/medical-devices" }, { "title": "Parallel distribution", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/parallel-distribution" }, { "title": "Certificates", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/certificates" }, { "title": "Quality defect and non-compliance", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/quality-defect-non-compliance" }, { "title": "Referral procedure", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/referral-procedure" }, { "title": "Sampling and testing of CAPs", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/sampling-testing-caps" }, { "title": "Scientific advice", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/scientific-advice" }, { "title": "Translations", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/translations" }, { "title": "Variations and other related processes", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/variations-other-related-processes" }, { "title": "Regulatory and Scientific Guidelines", "summary": "", "categories": "Corporate", "first_published_date": "22/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/regulatory-scientific-guidelines" }, { "title": "Variations requiring assessment (veterinary medicines)", "summary": "This page provides guidance on how to apply for a variation on centrally authorised veterinary medicines requiring assessment under the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6). This includes information on the documents that marketing authorisation holders will need to submit as part of the variation procedure.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "16/04/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-requiring-assessment-veterinary-medicines" }, { "title": "Assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/assessment-public-health-risks-related-antimicrobial-resistance-acquired-environment-resulting-use-veterinary-medicinal-product-scientific-guideline" }, { "title": "Getting involved in EMA activities as a healthcare professional", "summary": "Healthcare professionals are involved in a wide range of European Medicines Agency (EMA) activities.", "categories": "", "first_published_date": "29/02/2012", "last_updated_date": "15/04/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/healthcare-professionals/getting-involved-ema-activities-healthcare-professional" }, { "title": "Getting involved in EMA activities as a patient, consumer or carer", "summary": "Patients, consumers and carers are involved in a wide range of European Medicines Agency (EMA) activities.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "15/04/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers/getting-involved-ema-activities-patient-consumer-or-carer" }, { "title": "Non-clinical Working Party", "summary": "The Non-clinical Working Party (NcWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to provide advice and recommendations directly or indirectly related to non-clinical aspects.", "categories": "Human;Corporate", "first_published_date": "28/09/2023", "last_updated_date": "15/04/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/non-clinical-working-party" }, { "title": "Nitrosamines Safety Operational Expert Group", "summary": "The Nitrosamines Safety Operational Expert Group (NS OEG) supports the operational work of the Non-clinical Working Party related to the risk assessment of nitrosamines.", "categories": "Human;Corporate", "first_published_date": "02/10/2023", "last_updated_date": "15/04/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/nitrosamines-safety-operational-expert-group" }, { "title": "Evaluation of medicinal products indicated for treatment of bacterial infections - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/04/2004", "last_updated_date": "14/04/2025", "general_url": "https://www.ema.europa.eu/en/evaluation-medicinal-products-indicated-treatment-bacterial-infections-scientific-guideline" }, { "title": "Product-information (QRD) templates - Human", "summary": "The European Medicines Agency's (EMA) Working Group on Quality Review of Documents (QRD) develops, reviews and updates templates for product information for use by applicants and marketing authorisation holders for human medicines.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "14/04/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/product-information-qrd-templates-human" }, { "title": "Contacts at the European Medicines Agency", "summary": "On this page you can find several ways to contact the European Medicines Agency (EMA) depending on your need for assistance or type of request. ", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "14/04/2025", "general_url": "https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency" }, { "title": "Template for the qualified person's (QP) declaration concerning good manufacturing practice compliance of active substance manufacture \"The QP declaration template\" - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "17/06/2014", "last_updated_date": "11/04/2025", "general_url": "https://www.ema.europa.eu/en/template-qualified-persons-qp-declaration-concerning-good-manufacturing-practice-compliance-active-substance-manufacture-qp-declaration-template-scientific-guideline" }, { "title": "Clinical investigation of medicinal products in the treatment of depression - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/05/2013", "last_updated_date": "11/04/2025", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-depression-scientific-guideline" }, { "title": "Tolvaptan product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "02/04/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/tolvaptan-product-specific-bioequivalence-guidance" }, { "title": "Expert panel support for orphan medical devices", "summary": "Manufacturers of orphan medical devices and notified bodies can apply for the European Medicines Agency's (EMA) established process to support orphan medical devices.", "categories": "Human", "first_published_date": "28/11/2018", "last_updated_date": "01/04/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-orphan-medical-devices" }, { "title": "Scientific data requirements for plasma master file - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/11/2006", "last_updated_date": "31/03/2025", "general_url": "https://www.ema.europa.eu/en/scientific-data-requirements-plasma-master-file-scientific-guideline" }, { "title": "Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/06/2023", "last_updated_date": "31/03/2025", "general_url": "https://www.ema.europa.eu/en/development-guideline-quality-aspects-mrna-vaccines-scientific-guideline" }, { "title": "History of EMA", "summary": "Founded in 1995, the European Medicines Agency (EMA) is working across the European Union (EU) and globally to protect public and animal health. It is doing so by assessing medicines to rigorous scientific standards. EMA is also providing partners and stakeholders with independent, science-based information on medicines.", "categories": "Corporate", "first_published_date": "26/01/2015", "last_updated_date": "28/03/2025", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema" }, { "title": "EudraVigilance: how to register", "summary": "Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.", "categories": "", "first_published_date": "17/06/2016", "last_updated_date": "27/03/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/pharmacovigilance-research-and-development/eudravigilance/eudravigilance-how-register" }, { "title": "Notifying a change of marketing status", "summary": "This page lists questions relating to the notification of marketing and cessation, suspension, withdrawal of a medicinal product from the market and withdrawal of a marketing authorisation. It also covers 'sunset-clause' monitoring.", "categories": "Human", "first_published_date": "31/10/2013", "last_updated_date": "25/03/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/notifying-change-marketing-status" }, { "title": "Applying for marketing authorisation: orphan medicines", "summary": "", "categories": "Human", "first_published_date": "30/03/2010", "last_updated_date": "19/03/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/orphan-designation-marketing-authorisation/applying-marketing-authorisation-orphan-medicines" }, { "title": "Methylphenidate product-specific bioequivelance guidance", "summary": "", "categories": "Human", "first_published_date": "17/03/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/methylphenidate-product-specific-bioequivelance-guidance" }, { "title": "Network Portfolio", "summary": "The Network Portfolio is the collective term for information technology (IT) systems and services managed by the European Medicines Agency (EMA). These may be under development or in production and use by the European medicines regulatory network, EMA's stakeholders and EMA's staff.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "13/03/2025", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/information-management/network-portfolio" }, { "title": "Antimicrobial resistance in veterinary medicine", "summary": "Combatting the threat of antimicrobial resistance, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network. In veterinary medicine, EMA is promoting prudent use of antimicrobials in animals, collecting data on the use of veterinary antimicrobials in the European Union (EU), and providing scientific recommendations on the use of specific antimicrobials in animals.", "categories": "Veterinary", "first_published_date": "30/06/2016", "last_updated_date": "10/03/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine" }, { "title": "Veterinary product information (QRD) templates", "summary": "The European Medicines Agency's (EMA) provides templates for product information for use by applicants and marketing authorisation holders of veterinary medicines. EMA's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "10/03/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/product-information-requirements-veterinary-medicines/veterinary-product-information-qrd-templates" }, { "title": "Reliance for post-authorisation changes: pilots for the pharmaceutical industry", "summary": "The European Medicines Agency (EMA) collaborates with national authorities from countries outside of the European Union (EU), with the World Health Organization (WHO) and with the pharmaceutical industry to test a global model for handling major post-authorisation changes. This happens via pilot programmes that enable national authorities to use EMA's assessments to inform their own decision-making processes. This approach is based on the principle of reliance. It can help authorities streamline processes, make better use of resources and facilitate patient access to quality-assured medicines.", "categories": "Corporate", "first_published_date": "28/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-applied-post-autorisation-changes-pilots-pharmaceutical-industry" }, { "title": "Nitrosamine impurities in specific medicines", "summary": "Between 2018 and 2021, the European medicines regualtory network, in line with its international partners, has taken action to manage the risk of nitrosamine impurities in certain types of medicines on the European market within safe limits.", "categories": "Human", "first_published_date": "19/11/2024", "last_updated_date": "28/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities/nitrosamine-impurities-specific-medicines" }, { "title": "Investigation of bioequivalence - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "26/02/2025", "general_url": "https://www.ema.europa.eu/en/investigation-bioequivalence-scientific-guideline" }, { "title": "ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/02/2023", "last_updated_date": "26/02/2025", "general_url": "https://www.ema.europa.eu/en/ich-guideline-m13a-bioequivalence-immediate-release-solid-oral-dosage-forms-scientific-guideline" }, { "title": "Clinical evaluation of new vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/10/2006", "last_updated_date": "26/02/2025", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-new-vaccines-scientific-guideline" }, { "title": "Good manufacturing practice", "summary": "Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.", "categories": "Human;Veterinary", "first_published_date": "31/03/2017", "last_updated_date": "24/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice" }, { "title": "Good distribution practice", "summary": "Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain.", "categories": "Human", "first_published_date": "31/03/2017", "last_updated_date": "24/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/good-distribution-practice" }, { "title": "Biosimilar medicines: marketing authorisation", "summary": "A biosimilar is biological medicine highly similar to another already approved biological medicine in the European Union (EU), for which marketing exclusivity rights have expired. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilar medicines before they can be approved and marketed in the EU.", "categories": "Human", "first_published_date": "12/05/2016", "last_updated_date": "24/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/biosimilar-medicines-marketing-authorisation" }, { "title": "Infectious Diseases Working Party", "summary": "The European Medicines Agency's (EMA) Infectious Diseases Working Party (IDWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) in order to carry out specific tasks related to infectious diseases.", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "21/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/infectious-diseases-working-party" }, { "title": "Oncology Working Party", "summary": "The European Medicines Agency's (EMA) Oncology Working Party (ONCWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) in order to carry out specific tasks related to oncology (including haematological malignancies).", "categories": "Human;Corporate", "first_published_date": "03/10/2023", "last_updated_date": "21/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/oncology-working-party" }, { "title": "Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "03/02/2016", "last_updated_date": "21/02/2025", "general_url": "https://www.ema.europa.eu/en/demonstration-efficacy-veterinary-medicinal-products-containing-antimicrobial-substances-scientific-guideline" }, { "title": "Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "08/03/2000", "last_updated_date": "21/02/2025", "general_url": "https://www.ema.europa.eu/en/conduct-efficacy-studies-intramammary-products-use-cattle-scientific-guideline" }, { "title": "How to recognise scams using EMA credentials", "summary": "The European Medicines Agency (EMA) is aware of citizens being approached by illegal third parties who use EMA's credentials to ask for money. EMA does not ask citizens for payment of any sort. We interact with companies and individuals based on regulatory procedures we are responsible for.", "categories": "Corporate", "first_published_date": "20/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/how-recognise-scams-using-ema-credentials" }, { "title": "Generic and hybrid applications", "summary": "The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). To help applicants, EMA has published questions and answers (Q&As) on its position on issues applicants preparing to request marketing authorisation for generic or hybrid medicines typically raise.", "categories": "Human", "first_published_date": "12/05/2017", "last_updated_date": "19/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/generic-hybrid-medicines/generic-hybrid-applications" }, { "title": "Template for a European Union herbal monograph", "summary": "", "categories": "Herbal", "first_published_date": "11/03/2016", "last_updated_date": "17/02/2025", "general_url": "https://www.ema.europa.eu/en/template-european-union-herbal-monograph" }, { "title": "Template for assessment report for the development of European Union herbal monographs and list entries", "summary": "", "categories": "Herbal", "first_published_date": "24/06/2016", "last_updated_date": "17/02/2025", "general_url": "https://www.ema.europa.eu/en/template-assessment-report-development-european-union-herbal-monographs-list-entries" }, { "title": "Clinical pharmacology and pharmacokinetics guidelines", "summary": "", "categories": "Human", "first_published_date": "26/03/2010", "last_updated_date": "14/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics-guidelines" }, { "title": "Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development", "summary": "", "categories": "Human", "first_published_date": "14/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/guideline-assessment-reporting-mechanistic-models-used-context-model-informed-drug-development" }, { "title": "Overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "06/04/2018", "last_updated_date": "13/02/2025", "general_url": "https://www.ema.europa.eu/en/overview-current-regulatory-testing-requirements-veterinary-medicinal-products-opportunities-implementation-3rs-scientific-guideline" }, { "title": "Overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/04/2018", "last_updated_date": "13/02/2025", "general_url": "https://www.ema.europa.eu/en/overview-current-regulatory-testing-requirements-medicinal-products-human-use-opportunities-implementation-3rs-scientific-guideline" }, { "title": "Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "12/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/budesonide-gastro-resistant-hard-capsules-prolonged-release-properties-3-mg-product-specific-bioequivalence-guidance" }, { "title": "Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "12/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/budesonide-gastro-resistant-hard-capsules-3-mg-gastro-resistant-granules-9-mg-product-specific-bioequivalence-guidance" }, { "title": "Budesonide, prolonged release tablets, 9 mg product- specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "12/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/budesonide-prolonged-release-tablets-9-mg-product-specific-bioequivalence-guidance" }, { "title": "Nilotinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "12/02/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/nilotinib-product-specific-bioequivalence-guidance" }, { "title": "Linguistic review - Human", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "10/02/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/linguistic-review-human" }, { "title": "Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/02/2019", "last_updated_date": "06/02/2025", "general_url": "https://www.ema.europa.eu/en/guideline-quality-non-clinical-clinical-requirements-investigational-advanced-therapy-medicinal-products-clinical-trials-scientific-guideline" }, { "title": "ICH Q8, Q9 and Q10 - questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2009", "last_updated_date": "05/02/2025", "general_url": "https://www.ema.europa.eu/en/ich-q8-q9-q10-questions-answers-scientific-guideline" }, { "title": "Vaccines Working Party", "summary": "The European Medicines Agency's (EMA) Vaccines Working Party (VWP) was established by the Committee for Medicinal Products for Human Use (CHMP) to carry out specific tasks related to vaccines.", "categories": "Human;Corporate", "first_published_date": "03/10/2023", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/vaccines-working-party" }, { "title": "Methodology Working Party", "summary": "The Methodology Working Party (MWP) was established by the Committee for Medicinal Products for Human Use (CHMP) in order to pool and use expertise in key areas such as biostatistics, modelling and simulation, clinical pharmacology and pharmacokinetics, pharmacogenomics and diagnostics, artificial intelligence and data science, and real-world evidence.", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/methodology-working-party" }, { "title": "3Rs Working Party", "summary": "The 3Rs Working Party (3RsWP) is a joint working party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Veterinary Medicinal Products (CVMP). It advises these committees on all matters concerning the use of animals in the regulatory testing of medicines, with particular focus on the application of the so-called 3Rs principles - replace, reduce and refine.", "categories": "Human;Veterinary;Corporate", "first_published_date": "30/09/2022", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/3rs-working-party" }, { "title": "Quality Working Party", "summary": "The Quality Working Party (QWP) is a joint working party of the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Veterinary Medicinal Products (CVMP). The QWP provides recommendations to the European Medicines Agency's (EMA) scientific committees on all matters related to quality aspects of medicines with chemical active substances.", "categories": "Human;Veterinary", "first_published_date": "03/10/2023", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/quality-working-party" }, { "title": "Dosage Review and Adjustment of Established Veterinary Antibiotics temporary Working Party", "summary": "The Dosage Review and Adjustment of Established Veterinary Antibiotics (ADRA) temporary Working Party offers expertise to the European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP).", "categories": "Veterinary", "first_published_date": "30/09/2022", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp-working-parties-other-groups/dosage-review-adjustment-established-veterinary-antibiotics-temporary-working-party" }, { "title": "Haematology Working Party", "summary": "The European Medicines Agency's (EMA) Haematology Working Party (HAEMWP), formerly known as the Blood Products Working Party (BPWP), was set up by the Committee for Medicinal Products for Human Use (CHMP) to carry out specific tasks related to non-malignant haematology.", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-domains/chmp/haematology-working-party" }, { "title": "Biologics Working Party", "summary": "The Biologics Working Party (BWP) is a working party of the Committee for Medicinal Products for Human Use (CHMP). The BWP provides recommendations to the European Medicines Agency's (EMA) scientific committees on all matters related to the quality aspects of medicines with biological or biotechnological active substances.", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/biologics-working-party" }, { "title": "Biosimilar Medicinal Products Working Party", "summary": "The Biosimilar Medicinal Products Working Party (BMWP) provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) on clinical or non-clinical matters relating directly or indirectly to biosimilar medicines, and on the conduct of pharmaceutical tests on biosimilar medicinal products. These tests are needed to ensure the comparability of the old and new versions of biological medicinal products, when manufacturers make changes to such products during their lifecycle, or choose to develop new products which are biologically similar that could affect their quality, safety or efficacy.", "categories": "Human;Herbal", "first_published_date": "31/12/2009", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/biosimilar-medicinal-products-working-party" }, { "title": "Cardiovascular Working Party", "summary": "The European Medicines Agency's (EMA) Cardiovascular Working Party (CVSWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to carry out specific tasks related to the cardiovascular system, diabetes and obesity.", "categories": "Human;Corporate", "first_published_date": "25/10/2010", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/cardiovascular-working-party" }, { "title": "Central Nervous System Working Party", "summary": "The European Medicines Agency's (EMA) Central Nervous System Working Party (CNSWP) was set up by the Committee for Medicinal Products for Human Use (CHMP) to carry out specific tasks related to the central nervous system.", "categories": "Human;Corporate", "first_published_date": "25/10/2010", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-domains/chmp/central-nervous-system-working-party" }, { "title": "Biologics Working Party Vaccines Quality Operational Expert Group (BV OEG)", "summary": "The Vaccines Quality Operational Expert Group (BV OEG) advises the European Medicines Agency (EMA) on vaccine quality. The operational expert group also proposes recommendations for the annual influenza vaccine.", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "04/02/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/biologics-working-party-vaccines-quality-operational-expert-group-bv-oeg" }, { "title": "Falsified medicines: overview", "summary": "Falsified medicines are fake medicines that pass themselves off as real, authorised medicines. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet. The European Medicines Agency is working closely with its partners on the implementation of these laws.", "categories": "Human;Veterinary", "first_published_date": "23/11/2009", "last_updated_date": "30/01/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/falsified-medicines-overview" }, { "title": "Assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food-producing animal species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "04/03/2015", "last_updated_date": "24/01/2025", "general_url": "https://www.ema.europa.eu/en/assessment-risk-public-health-antimicrobial-resistance-due-use-antimicrobial-veterinary-medicinal-product-food-producing-animal-species-scientific-guideline" }, { "title": "Veterinary medicinal products for zootechnical purposes - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/03/1992", "last_updated_date": "24/01/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-medicinal-products-zootechnical-purposes-scientific-guideline" }, { "title": "(Invented) Name Review Group", "summary": "The (Invented) Name Review Group (NRG) was established by the Committee for Medicinal Products for Human Use (CHMP) to perform reviews of the (invented) names of medicinal products being assessed by the Agency.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "22/01/2025", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/invented-name-review-group" }, { "title": "Opening procedures at EMA to non-EU authorities (OPEN) framework", "summary": "The European Medicines Agency (EMA) collaborates with medicine regulators outside the European Union (EU) in the scientific evaluation of certain medicines, within a framework called OPEN (opening procedures at EMA to non-EU authorities).", "categories": "Corporate", "first_published_date": "03/07/2023", "last_updated_date": "21/01/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/opening-procedures-ema-non-eu-authorities-open-framework" }, { "title": "Financial advantages of SME status", "summary": "The European Medicines Agency (EMA) offers full or partial fee exemptions for its pre- and post-authorisation regulatory procedures for micro, small and medium-sized enterprises (SMEs) who want to develop and market medicines in the European Union (EU) and the European Economic Area (EEA).", "categories": "Human;Veterinary", "first_published_date": "07/12/2021", "last_updated_date": "15/01/2025", "general_url": "https://www.ema.europa.eu/en/about-us/support-smes/financial-advantages-sme-status" }, { "title": "Reform of the EU pharmaceutical legislation", "summary": "Information on the upcoming changes introduced by the European Union's (EU) comprehensive overhaul of its pharmaceutical legislation.", "categories": "Human;Veterinary", "first_published_date": "15/01/2025", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation" }, { "title": "Health technology assessment bodies", "summary": "The European Medicines Agency (EMA) is working closely with health technology assessment (HTA) bodies. HTA helps European Union (EU) Member States decide on the use, price and reimbursement level of a new health technology. It supports them in ensuring the quality, accessibility and sustainability of healthcare.", "categories": "Human", "first_published_date": "25/10/2010", "last_updated_date": "10/01/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/health-technology-assessment-bodies" }, { "title": "Pharmacovigilance Inspectors Working Group", "summary": "The Pharmacovigilance Inspectors Working Group (PhV IWG) was established by the European Medicines Agency with the remit to focus on harmonisation and co-ordination of PhV-related activities at the European Union (EU) level.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "07/01/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation/pharmacovigilance-inspections-veterinary-medicines/pharmacovigilance-inspectors-working-group" }, { "title": "Certification of medicinal products", "summary": "The purpose of the European Medicines Agency's (EMA) certification scheme for human and veterinary medicines is to confirm the medicine's marketing authorisation status and that it complies with good manufacturing practice (GMP) standards. This aims to support the work of health authorities outside the European Union (EU). ", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "06/01/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/certification-medicinal-products" }, { "title": "Trametinib product-specific bioequivalence guideline", "summary": "", "categories": "Human", "first_published_date": "19/12/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/trametinib-product-specific-bioequivalence-guideline" }, { "title": "Assessment templates and guidance (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "10/03/2022", "last_updated_date": "18/12/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/assessment-templates-guidance-veterinary-medicines" }, { "title": "Dexmedetomidine Accord", "summary": "", "categories": "Human", "first_published_date": "18/12/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/dexmedetomidine-accord" }, { "title": "ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2007", "last_updated_date": "18/12/2024", "general_url": "https://www.ema.europa.eu/en/ich-q4b-evaluation-recommendation-pharmacopoeial-texts-use-ich-regions-scientific-guideline" }, { "title": "HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (2016-2024)", "summary": "The Heads of Medicines Agencies (HMA) / European Medicines Agency (EMA) Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TF-AAM) provided strategic and structural solutions to tackle disruptions in the supply of medicines and ensure their continued availability in the European Union (EU). It focused on the availability of authorised human and veterinary medicines, irrespective of the authorisation route. It functioned between 2016 and end of 2024.", "categories": "Human;Veterinary", "first_published_date": "07/11/2023", "last_updated_date": "17/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/hma-ema-task-force-availability-authorised-medicines-human-veterinary-use-2016-2024" }, { "title": "Medicine shortages and availability issues: guidance for regulators", "summary": "Guidance is available from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to assist the national competent authorities in the European Union (EU) in effectively communicating to the public about issues related to the availability of human and veterinary medicines. Resources are also available to help them manage shortages caused by manufacturing or quality problems.", "categories": "Human;Veterinary", "first_published_date": "07/11/2023", "last_updated_date": "17/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-regulators" }, { "title": "Renewal and annual re-assessment of marketing authorisation", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on renewals of marketing authorisations, annual renewals of conditional marketing authorisations and annual re-assessments of marketing authorisations granted in exceptional circumstances.", "categories": "Human", "first_published_date": "11/05/2010", "last_updated_date": "17/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/renewal-annual-re-assessment-marketing-authorisation" }, { "title": "ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline", "summary": "This guidance describes non-clinical testing strategy for assessing the potential of a test substance to delay ventricular repolarization.", "categories": "Human", "first_published_date": "31/05/2005", "last_updated_date": "17/12/2024", "general_url": "https://www.ema.europa.eu/en/ich-s7b-non-clinical-evaluation-potential-delayed-ventricular-repolarization-qt-interval-prolongation-human-pharmaceuticals-scientific-guideline" }, { "title": "VICH GL8 Stability testing for medicated premixes - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1999", "last_updated_date": "16/12/2024", "general_url": "https://www.ema.europa.eu/en/vich-gl8-stability-testing-medicated-premixes-scientific-guideline" }, { "title": "Live recombinant vector vaccines for veterinary use - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/12/2004", "last_updated_date": "13/12/2024", "general_url": "https://www.ema.europa.eu/en/live-recombinant-vector-vaccines-veterinary-use-scientific-guideline" }, { "title": "Requesting certificates", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "13/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/certification-medicinal-products/requesting-certificates" }, { "title": "Antimicrobials Working Party", "summary": "The Antimicrobials Working Party (AWP) provides advice to the Committee for Veterinary Medicinal Products (CVMP) on matters concerning antimicrobials and antimicrobial resistance.", "categories": "Veterinary", "first_published_date": "14/01/2013", "last_updated_date": "13/12/2024", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-domains/cvmp/antimicrobials-working-party" }, { "title": "Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/02/2017", "last_updated_date": "13/12/2024", "general_url": "https://www.ema.europa.eu/en/assessing-toxicological-risk-human-health-groundwater-communities-veterinary-pharmaceuticals-groundwater-scientific-guideline" }, { "title": "Public-health advice on COVID-19 medicines", "summary": "Since the onset of the COVID-19 pandemic, the European Medicines Agency (EMA) has provided impartial advice to patients and healthcare professionals on the safe use of medicines, in particular in patients with or at risk of COVID-19 infection.", "categories": "Human", "first_published_date": "17/04/2020", "last_updated_date": "13/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/public-health-advice-covid-19-medicines" }, { "title": "Public information on medicine shortages", "summary": "The European Medicines Agency (EMA) publishes information on medicine shortages that affect or are likely to affect more than one European Union (EU) country, where it has assessed the shortage and provided recommendations to patients and healthcare professionals.", "categories": "Human", "first_published_date": "04/11/2013", "last_updated_date": "09/12/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/public-information-medicine-shortages" }, { "title": "How to pay", "summary": "The European Medicines Agency (EMA) provides guidance to marketing authorisation holders and applicants on how to pay fees levied by EMA.", "categories": "Human;Veterinary", "first_published_date": "02/05/2016", "last_updated_date": "04/12/2024", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/how-pay" }, { "title": "Clinical requirements for non replacement therapy in haemophilia A and B - Scientific guideline", "summary": "This guideline describes the main clinical data needed to support an application for a marketing authorisation for non-replacement therapy for use in prevention of bleeding in patients with haemophilia A and/or haemophilia B", "categories": "Human", "first_published_date": "31/10/2023", "last_updated_date": "04/12/2024", "general_url": "https://www.ema.europa.eu/en/clinical-requirements-non-replacement-therapy-haemophilia-b-scientific-guideline" }, { "title": "Clinical evaluation of medicinal products used in weight control - Scientific guideline", "summary": "This guideline provides medicine developers guidance on the clinical evaluation of new medicinal products for promoting weight loss in obese adult patients.", "categories": "Human", "first_published_date": "15/11/2007", "last_updated_date": "03/12/2024", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-medicinal-products-used-weight-control-scientific-guideline" }, { "title": "Services and databases", "summary": "The European Medicines Agency (EMA) hosts a number of websites and systems to support its work. You can browse a selection of these below, A-Z.", "categories": "Corporate", "first_published_date": "07/12/2023", "last_updated_date": "28/11/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/services-databases" }, { "title": "Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "13/10/2023", "last_updated_date": "25/11/2024", "general_url": "https://www.ema.europa.eu/en/stability-testing-applications-variations-marketing-authorisation-veterinary-medicinal-products-scientific-guideline" }, { "title": "Scientific review on the risk of nitrosamine impurities in human medicines", "summary": "The European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities.   ", "categories": "Human", "first_published_date": "19/11/2024", "last_updated_date": "26/02/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/nitrosamine-impurities/scientific-review-risk-nitrosamine-impurities-human-medicines" }, { "title": "Guideline on the evaluation of the benefit-risk balance of veterinary medicinal products", "summary": "", "categories": "Veterinary", "first_published_date": "07/12/2022", "last_updated_date": "15/11/2024", "general_url": "https://www.ema.europa.eu/en/guideline-evaluation-benefit-risk-balance-veterinary-medicinal-products" }, { "title": "Expert reports on big data related topics", "summary": "The European Medicines Agency (EMA) and the Heads of Medicine Agencies (EMA) publish expert reports on big data to support their regulatory decision-making work. These documents review latest information and trends, and make recommendations for future actions in the field of big data.", "categories": "Human;Veterinary", "first_published_date": "29/10/2024", "last_updated_date": "15/11/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/expert-reports-big-data-related-topics" }, { "title": "Variations including extensions of marketing authorisations", "summary": "A variation is a change to the terms of a marketing authorisation. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations.", "categories": "Human", "first_published_date": "01/12/2016", "last_updated_date": "12/11/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations" }, { "title": "Stakeholder participation in information management", "summary": "The European Medicines Agency (EMA) provides information for stakeholders such as national competent authorities and pharmaceutical industry associations on how they can participate in the Agency's Agile way of working and governance.", "categories": "", "first_published_date": "15/09/2023", "last_updated_date": "05/11/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/information-management/stakeholder-participation-information-management" }, { "title": "Questions and answers on Article 82 referral procedures", "summary": "This guidance addresses a number of questions relating to Article 82 referral procedures to the Committee for Veterinary Medicinal Products (CVMP).", "categories": "Veterinary", "first_published_date": "04/11/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines/questions-answers-article-82-referral-procedures" }, { "title": "Questions and answers on Article 82 referral procedures based on Article 129(3)", "summary": "This guidance addresses a number of questions related to Article 82 referral procedures based on Article 129(3) to the Committee for Veterinary Medicinal Products (CVMP).", "categories": "Veterinary", "first_published_date": "04/11/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines/questions-answers-article-82-referral-procedures-based-article-1293" }, { "title": "Parallel distribution: Regulatory and procedural guidance", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/10/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/parallel-distribution/parallel-distribution-regulatory-procedural-guidance" }, { "title": "Educational projects on cancer medicine regulation", "summary": "The European Medicines Agency (EMA) is running and supporting programmes enabling stakeholders such as scientists and patients to better understand and contribute to medicine regulation.", "categories": "Human", "first_published_date": "28/10/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines/educational-projects-cancer-medicine-regulation" }, { "title": "Cancer Medicines Pathfinder", "summary": "The European Medicines Agency (EMA) has launched the 'Cancer Medicines Pathfinder' project to address the increasing burden of cancer in the European Union (EU). This project aims to expedite and optimise the development and approval of cancer medicines.", "categories": "Human", "first_published_date": "28/10/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines/cancer-medicines-pathfinder" }, { "title": "Medical devices: expert panel advice at the request of the Medical Device Coordination Group and the European Commission", "summary": "The European Medicines Agency (EMA) publishes the advice of medical device expert panels on medical devices.", "categories": "", "first_published_date": "17/10/2024", "last_updated_date": "28/10/2024", "general_url": "https://www.ema.europa.eu/en/medical-devices-expert-panel-advice-request-medical-device-coordination-group-european-commission" }, { "title": "Patient engagement in oncology", "summary": "The European Medicines Agency (EMA) is working closely with partners in the European medicines regulatory network and at international level to improve engagement with people living with and affected by cancer. Europe accounts for a quarter of all cancer cases recorded worldwide.", "categories": "Human", "first_published_date": "25/10/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/cancer-medicines/patient-engagement-oncology" }, { "title": "Big data training curriculum", "summary": "The Big data training curriculum is a collection of training modules. It is meant to help European medicines regulatory network staff to develop expertise in integrating big data analysis into decision-making processes related to medicine regulation.", "categories": "Human", "first_published_date": "24/07/2024", "last_updated_date": "22/10/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/big-data-training-curriculum" }, { "title": "Quality Drafting Group", "summary": "", "categories": "Herbal", "first_published_date": "03/10/2023", "last_updated_date": "21/10/2024", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/hmpc/quality-drafting-group" }, { "title": "Quality data requirements for applications for biological veterinary medicinal products intended for limited markets - Scientific guideline", "summary": "The aim of this guidance is to define acceptable data requirements for the demonstration of the quality of biological veterinary medicinal products, including immunological veterinary medicinal (IVMPs) products, classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.", "categories": "Veterinary", "first_published_date": "15/09/2023", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/quality-data-requirements-applications-biological-veterinary-medicinal-products-intended-limited-markets-scientific-guideline" }, { "title": "Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline", "summary": "This guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.", "categories": "Veterinary", "first_published_date": "20/07/2006", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/efficacy-target-animal-safety-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-not-eligible-authorisation-under-article-23-regulation-eu-2019-6" }, { "title": "Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 - Scientific guideline", "summary": "This guideline clarifies the safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.", "categories": "Veterinary", "first_published_date": "15/09/2023", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/safety-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-not-eligible-authorisation-under-article-23-regulation-eu-2019-6-scientific" }, { "title": "Cookies", "summary": "This website uses cookies to improve its functionality and user experience. Users have full control over their cookie settings, with several ways to manage cookie preferences. This website does not collect personal data.", "categories": "Corporate", "first_published_date": "18/05/2017", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/cookies" }, { "title": "Safety and efficacy data requirements for applications for immunological VMPs intended for limited markets but not eligible for authorisation under Art 23 of Reg (EU) 2019-6 - Scientific guideline", "summary": "The aim of this guidance is to define acceptable data requirements for the demonstration of safety and efficacy of immunological veterinary medicinal products (IVMPs) classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6 but not eligible for authorisation under Article 23 of same Regulation.", "categories": "Human", "first_published_date": "15/09/2023", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/safety-efficacy-data-requirements-applications-immunological-vmps-intended-limited-markets-not-eligible-authorisation-under-art-23-reg-eu-2019-6-scientific-guideline" }, { "title": "User behaviour data: Europa Analytics", "summary": "The European Medicines Agency (EMA) uses Europa Analytics to monitor and evaluate this website. Europa Analytics uses cookies to collect anonymous data on user behavior. These data allow EMA to improve website functionality. Users can control their cookie preferences.", "categories": "Corporate", "first_published_date": "18/05/2017", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/user-behaviour-data-europa-analytics" }, { "title": "Use of clinical study data in medicine evaluation", "summary": "Clinical study data refer to individual patient data from clinical studies. The European Medicines Agency (EMA) aims to assess whether using clinical study data can help speed up and improve the medicine-evaluation process.", "categories": "Human", "first_published_date": "24/07/2024", "last_updated_date": "18/10/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/use-clinical-study-data-medicine-evaluation" }, { "title": "Class D in vitro diagnostic devices: expert panel views", "summary": "The European Medicines Agency (EMA) publishes the views of the in-vitro diagnostics expert panel on Class D in vitro diagnostic devices. It also publishes information on ongoing consultations.", "categories": "", "first_published_date": "17/10/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/class-d-vitro-diagnostic-devices-expert-panel-views" }, { "title": "Public health threats", "summary": "The European Medicines Agency (EMA) supports global efforts to respond to existing and emerging public health threats. These include antimicrobial resistance, biological and chemical threats and emergencies such as outbreaks or pandemics. EMA has a number of mechanisms in place to contribute to global responses to such challenges.", "categories": "Human", "first_published_date": "08/02/2016", "last_updated_date": "14/10/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats" }, { "title": "Clinical evaluation of therapeutic radiopharmaceuticals in oncology - Scientific guideline", "summary": "The objective of this concept paper is to identify aspects that are specific for tRPs that need to be addressed in the future guideline, to complement the more general guideline on the clinical evaluation of anticancer medicinal products (EMA/CHMP/205/95 Rev.6). The scope of the guideline is to provide specific guidance on how the key concepts from the two areas of legislation should be applied to the clinical development of tRPs for marketing authorisation application.", "categories": "Human", "first_published_date": "11/10/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-therapeutic-radiopharmaceuticals-oncology-scientific-guideline" }, { "title": "Website data protection notice", "summary": "The European Medicines Agency (EMA) collects and handles personal data when users visit this website. EMA treats personal data in line with EU law. Users have the right to object to the processing of personal data and can withdraw their consent.", "categories": "Corporate", "first_published_date": "26/01/2012", "last_updated_date": "04/10/2024", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/website-data-protection-notice" }, { "title": "Quality and equivalence of locally applied, locally acting cutaneous products - Scientific guideline", "summary": "The guideline relates to locally applied and locally acting medicinal products for cutaneous use but may be also relevant for other medicines e.g., preparations for auricular or ocular use, and locally acting vaginal products.", "categories": "Human", "first_published_date": "22/04/2015", "last_updated_date": "01/10/2024", "general_url": "https://www.ema.europa.eu/en/quality-equivalence-locally-applied-locally-acting-cutaneous-products-scientific-guideline" }, { "title": "Use of Artificial Intelligence (AI) in the medicinal product lifecycle - Scientific guideline", "summary": "The reflection paper on the use of artificial intelligence in the lifecycle of medicines outlines the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines.", "categories": "Human", "first_published_date": "19/07/2023", "last_updated_date": "30/09/2024", "general_url": "https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle-scientific-guideline" }, { "title": "Patient experience data (PED) reflection paper", "summary": "The reflection paper on the patient experience data (PED) encourages medicine developers and other stakeholders to include this type of data in medicine development and marketing authorisation applications for human medicines. These are data that directly reflect the patient experience, without doctors or other parties interpreting them.", "categories": "Human", "first_published_date": "19/07/2023", "last_updated_date": "30/09/2024", "general_url": "https://www.ema.europa.eu/en/patient-experience-data-ped-reflection-paper" }, { "title": "Compilation of Union procedures on inspections and exchange of information", "summary": "The European Medicines Agency (EMA) maintains a compilation of inspection-related procedures and templates used by the good manufacturing practice (GMP) and good distribution practice (GDP) inspectorates in the European Union (EU) and European Economic Area (EEA).", "categories": "Human;Veterinary", "first_published_date": "01/08/2024", "last_updated_date": "26/09/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/compilation-union-procedures-inspections-exchange-information" }, { "title": "Efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of the Regulation (EU) 2019/6 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2021", "last_updated_date": "20/09/2024", "general_url": "https://www.ema.europa.eu/en/efficacy-target-animal-safety-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6-scientific" }, { "title": "Data requirements for applications for immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2021", "last_updated_date": "20/09/2024", "general_url": "https://www.ema.europa.eu/en/data-requirements-applications-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6-scientific-guideline" }, { "title": "Safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2021", "last_updated_date": "20/09/2024", "general_url": "https://www.ema.europa.eu/en/safety-residue-data-requirements-applications-non-immunological-veterinary-medicinal-products-intended-limited-markets-submitted-under-article-23-regulation-eu-2019-6-scientific-guideline" }, { "title": "Product-information requirements", "summary": "The European Medicines Agency (EMA) makes guidance and templates available to provide marketing authorisation applicants with practical advice on how to draw up the product information for human medicines, which includes the summary of product characteristics, labelling and package leaflet.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "19/09/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements" }, { "title": "Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation", "summary": "", "categories": "Human", "first_published_date": "21/04/2023", "last_updated_date": "16/09/2024", "general_url": "https://www.ema.europa.eu/en/establishing-efficacy-based-single-arm-trials-submitted-pivotal-evidence-marketing-authorisation" }, { "title": "Environmental risk assessment of medicinal products for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "12/09/2024", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-medicinal-products-human-use-scientific-guideline" }, { "title": "Questions and answers on the guideline on the environmental risk assessment of medicinal products for human use", "summary": "", "categories": "Human", "first_published_date": "11/04/2011", "last_updated_date": "11/09/2024", "general_url": "https://www.ema.europa.eu/en/questions-answers-guideline-environmental-risk-assessment-medicinal-products-human-use" }, { "title": "Clinical development of medicinal products for the treatment and prevention of bipolar disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/04/2001", "last_updated_date": "09/09/2024", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-treatment-prevention-bipolar-disorder-scientific-guideline" }, { "title": "Name Review Group form", "summary": "", "categories": "", "first_published_date": "01/06/2016", "last_updated_date": "05/09/2024", "general_url": "https://www.ema.europa.eu/en/name-review-group-form" }, { "title": "Support services", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "04/09/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures/support-services" }, { "title": "ICH guideline E11A on pediatric extrapolation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "03/09/2024", "general_url": "https://www.ema.europa.eu/en/ich-guideline-e11a-pediatric-extrapolation-scientific-guideline" }, { "title": "Quality defects and recalls", "summary": "The European Medicines Agency (EMA) coordinates the assessment of reports of product quality defects of centrally authorised medicines.", "categories": "Human;Veterinary", "first_published_date": "03/05/2018", "last_updated_date": "28/08/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/quality-defects-recalls" }, { "title": "Plasma Master File (PMF) submissions", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "20/08/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-pmf-submissions" }, { "title": "Biological and chemical threats", "summary": "The European Medicines Agency (EMA) has developed guidance on the use of medicines for treatment and prevention in case of exposure to biological or chemical agents used for terrorism, crime or warfare. This guidance is meant to support the routine preparedness activities of public health authorities across the European Union (EU).", "categories": "Human", "first_published_date": "01/12/2016", "last_updated_date": "12/08/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/biological-chemical-threats" }, { "title": "Withdrawn applications and products", "summary": "", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "09/08/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/withdrawn-applications-products" }, { "title": "Environmental Risk Assessment European Specialised Expert Community", "summary": "", "categories": "Human;Veterinary", "first_published_date": "30/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-european-specialised-expert-community" }, { "title": "Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products", "summary": "The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.", "categories": "Human", "first_published_date": "26/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-development-guideline-demonstration-therapeutic-equivalence-nasal-products" }, { "title": "Dossier requirements for anticancer medicinal products for dogs and cats - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/04/2009", "last_updated_date": "26/07/2024", "general_url": "https://www.ema.europa.eu/en/dossier-requirements-anticancer-medicinal-products-dogs-cats-scientific-guideline" }, { "title": "Paliperidone palmitate depot suspension for injection (every 3 months) 175, 263, 350 and 525 mg product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "26/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/paliperidone-palmitate-depot-suspension-injection-every-3-months-175-263-350-525-mg-product-specific-bioequivalence-guidance" }, { "title": "Conduct of bioequivalence studies for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/04/2011", "last_updated_date": "26/07/2024", "general_url": "https://www.ema.europa.eu/en/conduct-bioequivalence-studies-veterinary-medicinal-products-scientific-guideline" }, { "title": "User safety for pharmaceutical veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/03/2010", "last_updated_date": "26/07/2024", "general_url": "https://www.ema.europa.eu/en/user-safety-pharmaceutical-veterinary-medicinal-products-scientific-guideline" }, { "title": "Poorly extractable and/or non- radiolabelled substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "29/03/2016", "last_updated_date": "26/07/2024", "general_url": "https://www.ema.europa.eu/en/poorly-extractable-or-non-radiolabelled-substances-scientific-guideline" }, { "title": "Determining the fate of veterinary medicinal products in manure - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/03/2011", "last_updated_date": "26/07/2024", "general_url": "https://www.ema.europa.eu/en/determining-fate-veterinary-medicinal-products-manure-scientific-guideline" }, { "title": "Multidisciplinary: Nasal products", "summary": "The European Medicines Agency's scientific guidelines on nasal products help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "25/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/multidisciplinary-nasal-products" }, { "title": "Multidisciplinary guidelines", "summary": "The European Medicines Agency's (EMA) multidisciplinary guidelines on the development of human medicines help applicants prepare marketing authorisation applications.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "25/07/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines" }, { "title": "Development and manufacture of oligonucleotides - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/development-manufacture-oligonucleotides-scientific-guideline" }, { "title": "European Union agencies", "summary": "The European Medicines Agency (EMA) works closely with other decentralised agencies of the European Union (EU), particularly those with similar areas of work.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "17/07/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/european-union-agencies" }, { "title": "China", "summary": "The European Medicines Agency (EMA) supports the European Commission's activities in China, India and Russia, by contributing to interactions on pharmaceuticals between the European Union (EU) and the regulatory authorities of these countries.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "16/07/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/china" }, { "title": "Post-authorisation measures (recommendations, conditions and specific obligations): veterinary medicines", "summary": "Guidance is available from the European Medicines Agency (EMA) on veterinary post-authorisation measures in the form of questions and asnwers (Q&As).", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "15/07/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/post-authorisation-measures-recommendations-conditions-specific-obligations-veterinary-medicines" }, { "title": "Meetings management procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "11/07/2024", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/meeting-management-procedures/meetings-management-procedures" }, { "title": "Scientific recommendations on classification of advanced therapy medicinal products", "summary": "The European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). ", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "10/07/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation/scientific-recommendations-classification-advanced-therapy-medicinal-products" }, { "title": "Veterinary big data", "summary": "The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) are jointly running a multi-year veterinary big data initiative, to help the European medicines regulatory network move towards a more data-driven culture in the regulation of veterinary medicines in the European Union (EU). ", "categories": "Veterinary", "first_published_date": "24/05/2023", "last_updated_date": "10/07/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-big-data" }, { "title": "International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)", "summary": "The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the medicines regulatory authorities and pharmaceutical industry around the world.", "categories": "Human", "first_published_date": "28/09/2017", "last_updated_date": "03/07/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-council-harmonisation-technical-requirements-registration-pharmaceuticals-human-use-ich" }, { "title": "Concept paper on the revision of the COVID-19 vaccines guidance documents", "summary": "", "categories": "Human", "first_published_date": "01/07/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-revision-covid-19-vaccines-guidance-documents" }, { "title": "Core summary of product characteristics for human plasma-derived and recombinant coagulation factor IX products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/12/2014", "last_updated_date": "28/06/2024", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-recombinant-coagulation-factor-ix-products-scientific-guideline" }, { "title": "Clinical investigation of recombinant and human plasma-derived factor IX products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2015", "last_updated_date": "28/06/2024", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-ix-products-scientific-guideline" }, { "title": "Scientific advice for veterinary medicines", "summary": "The European Medicines Agency can give scientific advice to companies on the appropriate tests and studies in the development of veterinary medicines. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "26/06/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-advice" }, { "title": "Contracts and grants archive", "summary": "The European Medicines Agency (EMA) keeps an archive of its contracts and grants from 2016-2024.", "categories": "Corporate", "first_published_date": "17/01/2013", "last_updated_date": "25/06/2024", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive" }, { "title": "Scientific Advice Working Party: veterinary medicines", "summary": "The Scientific Advice Working Party (SAWP-V) was set up to provide recommendations to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating directly or indirectly to veterinary medicinal products.", "categories": "Veterinary", "first_published_date": "21/06/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp-working-parties-other-groups/scientific-advice-working-party-veterinary-medicines" }, { "title": "Patient registries", "summary": "Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide an adequate source of post-authorisation data for regulatory decision-making.", "categories": "Human", "first_published_date": "12/10/2015", "last_updated_date": "20/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/patient-registries" }, { "title": "Variations guidelines: Proposed amendments to the European Commission guidelines on variations categories and procedures", "summary": "The proposed amendments aim to make the lifecycle management of medicinal products for human use more efficient and future-proof.", "categories": "Human", "first_published_date": "13/06/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/variations-guidelines-proposed-amendments-european-commission-guidelines-variations-categories-procedures" }, { "title": "Pharmacovigilance: Overview", "summary": "Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The European Medicines Agency (EMA) coordinates the European Union (EU) pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU.", "categories": "Human", "first_published_date": "28/03/2017", "last_updated_date": "06/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview" }, { "title": "Annual report on deferrals", "summary": "The European Medicines Agency grants deferrals for some medicines. These allow an applicant to delay development of the medicine in children until there is, for instance, enough information to demonstrate its effectiveness and safety in adults.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "03/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/annual-report-deferrals" }, { "title": "Paediatric medicines: Overview", "summary": "The European Medicines Agency has a number of important tasks and responsibilities relating to the development of paediatric medicines. These responsibilities, granted through the European Union (EU) Paediatric Regulation, enable the Agency to stimulate research into the uses of medicines in children and to lead to their authorisation in all age groups.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "03/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overview" }, { "title": "Paediatric medicines: Research and development", "summary": "This section provides information on the European Medicines Agency's activities relating to paediatric medicines during the research and development stage. This includes guidance on paediatric investigation plans (PIPs) and other paediatric applications.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "03/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development" }, { "title": "Information Management", "summary": "The European Medicines Agency's (EMA) Information Management Division enables the Agency, its staff, members of its committees, working parties and advisory groups, and other stakeholders, to make efficient and effective use of information technology in order to achieve its organisational and policy objectives.", "categories": "Corporate", "first_published_date": "29/02/2012", "last_updated_date": "03/06/2024", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/information-management" }, { "title": "Removing an orphan designation", "summary": "The sponsor of a designated orphan medicine can request removal of its orphan designation from the European Commission's Community register of orphan medicinal products at any time.", "categories": "Human", "first_published_date": "02/07/2014", "last_updated_date": "03/06/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/removing-orphan-designation" }, { "title": "Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/06/2011", "last_updated_date": "31/05/2024", "general_url": "https://www.ema.europa.eu/en/creutzfeldt-jakob-disease-plasma-derived-urine-derived-medicinal-products-scientific-guideline" }, { "title": "Patients and consumers: Key documents", "summary": "The European Medicines Agency (EMA) makes available documents on key areas of the EMA's work with patients and consumers and their organisations.", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "29/05/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers/patients-consumers-key-documents" }, { "title": "National registers of authorised medicines", "summary": "The national medicine registers in the different Member States of the European Union (EU) and European Economic Area (EEA) contain information on medicines authorised in those countries, including links for the summary of product characteristics (SmPC) and the package leaflet.", "categories": "Human;Veterinary", "first_published_date": "28/03/2019", "last_updated_date": "29/05/2024", "general_url": "https://www.ema.europa.eu/en/medicines/national-registers-authorised-medicines" }, { "title": "Support for industry on clinical data publication", "summary": "The European Medicines Agency (EMA) has developed detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data.", "categories": "", "first_published_date": "20/10/2016", "last_updated_date": "24/05/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication" }, { "title": "Hopveus", "summary": "", "categories": "Human", "first_published_date": "15/05/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/hopveus" }, { "title": "Environmental Risk Assessment Working Party", "summary": "The Environmental Risk Assessment Working Party (ERAWP) provides advice to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating directly or indirectly to the environmental risk assessment of veterinary medicines, including the preparation of guidelines.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "14/05/2024", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/environmental-risk-assessment-working-party" }, { "title": "Safety and residues guidelines", "summary": "The European Medicines Agency's scientific guidelines on the safety and residues of veterinary medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "07/05/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines" }, { "title": "Safety and residues guidelines: biological substances other than immunologicals", "summary": "The European Medicines Agency's scientific guidelines on the biological substances other than immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "20/12/2011", "last_updated_date": "07/05/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines/safety-residues-guidelines-biological-substances-other-immunologicals" }, { "title": "ICH M10 on bioanalytical method validation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/03/2019", "last_updated_date": "03/05/2024", "general_url": "https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation-scientific-guideline" }, { "title": "Clinical efficacy and safety guidelines", "summary": "The European Medicines Agency's scientific guidelines on the clinical efficacy and safety of human medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "03/05/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines" }, { "title": "Real-world evidence guidelines", "summary": "", "categories": "Human", "first_published_date": "03/05/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/real-world-evidence-guidelines" }, { "title": "How the committees work", "summary": "The European Medicines Agency (EMA) has seven scientific committees and a number of working parties and related groups which conduct the scientific work of the Agency.", "categories": "Human;Veterinary", "first_published_date": "19/12/2016", "last_updated_date": "02/05/2024", "general_url": "https://www.ema.europa.eu/en/committees/how-committees-work" }, { "title": "How EMA evaluates medicines for human use", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorisations in the European Union (EU). This authorisation procedure allows pharmaceutical companies to market the medicine and make it available to patients and healthcare professionals throughout the European Economic Area (EEA) on the basis of a single marketing authorisation. ", "categories": "Corporate", "first_published_date": "01/07/2019", "last_updated_date": "02/05/2024", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/how-ema-evaluates-medicines-human-use" }, { "title": "Risk assessment of medicinal products on human reproduction and lactation: from data to labelling - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "02/05/2024", "general_url": "https://www.ema.europa.eu/en/risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling-scientific-guideline" }, { "title": "Use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "05/06/2014", "last_updated_date": "02/05/2024", "general_url": "https://www.ema.europa.eu/en/use-near-infrared-spectroscopy-nirs-pharmaceutical-industry-data-requirements-new-submissions-variations-scientific-guideline" }, { "title": "Resources for healthcare professionals", "summary": "The European Medicines Agency (EMA) makes available resource materials including videos and links to workshops for healthcare professionals interested in learning more about EMA activities.", "categories": "Human", "first_published_date": "15/02/2016", "last_updated_date": "30/04/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/healthcare-professionals/resources-healthcare-professionals" }, { "title": "Development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/development-guideline-safety-nanoparticles-context-establishment-maximum-residue-limits-veterinary-marketing-authorisations" }, { "title": "Scientific guidelines for veterinary medicines", "summary": "The European Medicines Agency's Committee for Medicinal Products for Veterinary Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for veterinary medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "26/04/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines" }, { "title": "Bilateral interactions with non-EU regulators", "summary": "The European Medicines Agency cooperates with many of the world's largest regulatory bodies outside the European Union (EU) in areas such as inspections, safety of medicines and exchange of information on issues of mutual concern.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "26/04/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators" }, { "title": "Pharmacovigilance guidelines", "summary": "", "categories": "Veterinary", "first_published_date": "24/04/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/pharmacovigilance-guidelines" }, { "title": "Training and resources for patients and consumers", "summary": "The European Medicines Agency (EMA) provides support to patient and consumer representatives invited to participate in its activities as well as training sessions plus a collection of training videos and documents for anyone interested in learning more about EMA's activities.", "categories": "Human", "first_published_date": "20/12/2013", "last_updated_date": "23/04/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers/training-resources-patients-consumers" }, { "title": "Republic of Korea", "summary": "The European Commission's Directorate-General for Health and Food Safety (DG-SANTE) and the European Medicines Agency (EMA) have in place a confidentiality arrangement with the Ministry of Food and Drug Safety of the Republic of Korea since 2024.", "categories": "Corporate", "first_published_date": "23/04/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/republic-korea" }, { "title": "European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)", "summary": "The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is a network of research networks, investigators and centres with recognised expertise in performing clinical studies in children.", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "19/04/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema" }, { "title": "Requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)", "summary": "", "categories": "Human", "first_published_date": "12/04/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/requirements-demonstrating-therapeutic-equivalence-between-orally-inhaled-products-oip-asthma-chronic-obstructive-pulmonary-disease-copd" }, { "title": "Reflection papers on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2017", "last_updated_date": "04/04/2024", "general_url": "https://www.ema.europa.eu/en/reflection-papers-regulatory-requirements-development-medicinal-products-chronic-non-infectious-liver-diseases-pbc-psc-nash-scientific-guideline" }, { "title": "Marketing authorisation templates", "summary": "This page lists templates applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).", "categories": "Human", "first_published_date": "20/01/2017", "last_updated_date": "03/04/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/marketing-authorisation-templates" }, { "title": "Medical literature monitoring", "summary": "The European Medicines Agency (EMA) is responsible for monitoring a number of substances and selected medical literature, to help identify suspected adverse reactions to medicines authorised in the European Union (EU). EMA also enters relevant information into the EudraVigilance database.", "categories": "Human", "first_published_date": "12/05/2015", "last_updated_date": "26/03/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medical-literature-monitoring" }, { "title": "EudraVigilance system overview", "summary": "EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.", "categories": "Human", "first_published_date": "17/06/2016", "last_updated_date": "18/03/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-system-overview" }, { "title": "Proline - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2018", "last_updated_date": "13/03/2024", "general_url": "https://www.ema.europa.eu/en/proline-scientific-guideline" }, { "title": "Coordination of pharmacovigilance inspections", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "12/03/2024", "general_url": "https://www.ema.europa.eu/en/coordination-pharmacovigilance-inspections-0" }, { "title": "Contacting EMA: post-authorisation", "summary": "Marketing authorisation holders may need to contact the European Medicines Agency (EMA) in a range of post-authorisation settings. During post-authorisation evaluation procedures, the Product Lead for the medicinal product is the primary contact point, but in certain circumstances there are different ways of contacting EMA.", "categories": "Human", "first_published_date": "01/01/2015", "last_updated_date": "08/03/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/contacting-ema-post-authorisation" }, { "title": "Liposomal amphotericin B product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/12/2021", "last_updated_date": "08/03/2024", "general_url": "https://www.ema.europa.eu/en/liposomal-amphotericin-b-product-specific-bioequivalence-guidance" }, { "title": "Templates for assessors", "summary": "", "categories": "Human", "first_published_date": "26/10/2011", "last_updated_date": "05/03/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/templates-assessors" }, { "title": "Signal Management Review Technical (SMART) Working Group", "summary": "The Signal Management Review Technical (SMART) Working Group is responsible for leveraging expertise in the field of signal management to strengthen and simplify related processes in the European Union (EU). The group is a collaboration between EU Member States and the European Medicines Agency (EMA).", "categories": "Corporate", "first_published_date": "23/02/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/signal-management-review-technical-smart-working-group" }, { "title": "Pharmacovigilance-related recommendations to product information for centrally authorised veterinary medicines", "summary": "The European Medicines Agency's (EMA) Committee for Veterinary Medicinal Products (CVMP) issues recommendations on updating the product information for centrally authorised veterinary medicines, based on an evaluation of safety data. The marketing authorisation holder of the medicine is responsible for implementing these CVMP recommendations.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "23/02/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/pharmacovigilance-related-recommendations-product-information-centrally-authorised-veterinary-medicines" }, { "title": "Clinical efficacy and safety guidelines: anti-infectives for systemic use", "summary": "", "categories": "Human", "first_published_date": "31/03/2010", "last_updated_date": "22/02/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-anti-infectives-systemic-use" }, { "title": "Non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/02/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-evaluation-antiviral-medicinal-products-monoclonal-antibodies-prevention-treatment-covid-19-scientific-guideline" }, { "title": "Analysis of antimicrobial consumption and resistance ('JIACRA' reports)", "summary": "The European Medicines Agency (EMA) works closely with the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) to analyse the potential relationship between the consumption of antimicrobials by humans and animals and the occurrence of antimicrobial resistance.", "categories": "Veterinary", "first_published_date": "27/07/2017", "last_updated_date": "21/02/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/analysis-antimicrobial-consumption-resistance-jiacra-reports" }, { "title": "Biostatistics guidelines", "summary": "", "categories": "Human", "first_published_date": "16/05/2014", "last_updated_date": "16/02/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/biostatistics-guidelines" }, { "title": "Safety of COVID-19 vaccines", "summary": "The European Medicines Agency (EMA) monitors the safety of COVID-19 vaccines authorised in the European Union (EU) extremely carefully. With hundreds of millions of people already vaccinated in the EU, this enables the continued detection of any rare side effects.", "categories": "Human", "first_published_date": "08/09/2021", "last_updated_date": "15/02/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines" }, { "title": "Paediatric Formulation Operational Expert Group", "summary": "", "categories": "Human", "first_published_date": "27/07/2011", "last_updated_date": "15/02/2024", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/pdco-working-parties-other-groups/paediatric-formulation-operational-expert-group" }, { "title": "European Network of Centres for Pharmacoepidemiology and Pharmacovigilance", "summary": "​​​​​​​Coordinated by the European Medicines Agency (EMA), the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) brings together expertise and resources in pharmacoepidemiology and pharmacovigilance across Europe.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "15/02/2024", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks/european-network-centres-pharmacoepidemiology-pharmacovigilance" }, { "title": "Notifying EMA of changes to contact persons (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "15/02/2024", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/notifying-ema-changes-contact-persons-veterinary-medicines" }, { "title": "Methodology European Specialised Expert Community", "summary": "The Methodology European Specialised Expert Community (Methodology ESEC) is a platform for information-sharing among European experts on scientific and methodological topics relevant to the European medicines regulatory network.", "categories": "Human", "first_published_date": "07/02/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/methodology-european-specialised-expert-community" }, { "title": "Plasmid DNA vaccines for veterinary use – Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/03/2000", "last_updated_date": "26/01/2024", "general_url": "https://www.ema.europa.eu/en/plasmid-dna-vaccines-veterinary-use-scientific-guideline" }, { "title": "Clinical data publication", "summary": "As of October 2016, the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA's flagship policy on the publication of clinical data.", "categories": "Human", "first_published_date": "22/11/2012", "last_updated_date": "26/01/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication" }, { "title": "Support to SMEs", "summary": "The European Medicines Agency (EMA) provides incentives and support for micro, small and medium-sized enterprises (SMEs) that are developing medicines for human or veterinary use, in order to promote innovation and the development of new medicines.", "categories": "Human;Veterinary", "first_published_date": "01/01/2016", "last_updated_date": "23/01/2024", "general_url": "https://www.ema.europa.eu/en/about-us/support-smes" }, { "title": "ICH guideline S11 on nonclinical safety testing in support of development of paediatric pharmaceuticals - Step 5 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/01/2024", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/ich-guideline-s11-nonclinical-safety-testing-support-development-paediatric-pharmaceuticals-step-5-scientific-guideline" }, { "title": "Orphans: Regulatory and procedural guidance and forms", "summary": "The European Medicines Agency (EMA) makes guidance documents on orphan designation available to stakeholders.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "19/01/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation/orphans-regulatory-procedural-guidance-forms" }, { "title": "Q&A: Good clinical practice (GCP)", "summary": "The European Medicines Agency (EMA) provides guidance in forms of questions and answers (Q&As) on good clinical practice (GCP), as discussed and agreed by the GCP Inspectors Working Group.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "12/01/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice/qa-good-clinical-practice-gcp" }, { "title": "Brexit-related guidance for companies", "summary": "The European Medicines Agency (EMA) and the European Commission have been providing guidance to help pharmaceutical companies prepare for the consequences of Brexit since 2017. This includes companies responsible for human medicines and for veterinary medicines, both centrally and nationally authorised.", "categories": "Human;Veterinary;Corporate", "first_published_date": "15/12/2017", "last_updated_date": "05/01/2024", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/brexit-united-kingdoms-withdrawal-european-union/brexit-related-guidance-companies" }, { "title": "Send a question to the European Medicines Agency", "summary": "Use this form to send a request for information from the European Medicines Agency (EMA) or to make a formal request for access to EMA documents that are not already published on this website.", "categories": "Corporate", "first_published_date": "24/10/2023", "last_updated_date": "20/12/2023", "general_url": "https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/send-question-european-medicines-agency" }, { "title": "Quality guidelines: specific types of products", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "19/12/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-specific-types-products" }, { "title": "Biologicals: finished product", "summary": "The European Medicines Agency's scientific guidelines on biological medicinal products help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "24/03/2010", "last_updated_date": "19/12/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guidelines/biologicals-finished-product" }, { "title": "Assessment of SmPC section 5.1: A Guide for Assessors of Centralised Applications - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/assessment-smpc-section-51-guide-assessors-centralised-applications-scientific-guideline" }, { "title": "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "15/12/2023", "general_url": "https://www.ema.europa.eu/en/guideline-acceptability-names-human-medicinal-products-processed-through-centralised-procedure-scientific-guideline" }, { "title": "Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "13/10/2023", "last_updated_date": "15/12/2023", "general_url": "https://www.ema.europa.eu/en/calculation-dose-factor-be-submitted-union-product-database-upd-scientific-guideline" }, { "title": "Conduct of pharmacokinetic studies in target animal species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "08/03/2000", "last_updated_date": "15/12/2023", "general_url": "https://www.ema.europa.eu/en/conduct-pharmacokinetic-studies-target-animal-species-scientific-guideline" }, { "title": "Notifying a change of marketing status and sunset clause (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "16/12/2010", "last_updated_date": "14/12/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/notifying-change-marketing-status-sunset-clause-veterinary-medicines" }, { "title": "Marketing authorisation (veterinary medicines)", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "14/12/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines" }, { "title": "Industry stakeholder platform meetings", "summary": "The European Medicines Agency (EMA) hosts stakeholder platform meetings with representatives of the pharmaceutical industry to address operational aspects linked to research and development for medicines, the centralised marketing authorisation procedure and pharmacovigilance.", "categories": "Human", "first_published_date": "21/09/2023", "last_updated_date": "28/11/2023", "general_url": "https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry/industry-stakeholder-platform-meetings" }, { "title": "Bosutinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/06/2023", "last_updated_date": "28/11/2023", "general_url": "https://www.ema.europa.eu/en/bosutinib-product-specific-bioequivalence-guidance" }, { "title": "Pirfenidone product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/06/2023", "last_updated_date": "28/11/2023", "general_url": "https://www.ema.europa.eu/en/pirfenidone-product-specific-bioequivalence-guidance" }, { "title": "Questions and answers on data requirements when transitioning to low global warming potential (LGWP) propellants in oral pressurised metered dose inhalers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "05/04/2023", "last_updated_date": "23/11/2023", "general_url": "https://www.ema.europa.eu/en/questions-answers-data-requirements-when-transitioning-low-global-warming-potential-lgwp-propellants-oral-pressurised-metered-dose-inhalers-scientific-guideline" }, { "title": "Regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "19/02/1997", "last_updated_date": "23/11/2023", "general_url": "https://www.ema.europa.eu/en/regulatory-acceptance-3r-replacement-reduction-refinement-testing-approaches-scientific-guideline" }, { "title": "Fampridine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/06/2023", "last_updated_date": "22/11/2023", "general_url": "https://www.ema.europa.eu/en/fampridine-product-specific-bioequivalence-guidance" }, { "title": "Environmental risk assessment of ectoparasiticidal veterinary medicinal products used in cats and dogs", "summary": "", "categories": "Veterinary", "first_published_date": "16/12/2022", "last_updated_date": "21/11/2023", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-ectoparasiticidal-veterinary-medicinal-products-used-cats-and-dogs" }, { "title": "Multilateral coalitions and initiatives", "summary": "The European Medicines Agency (EMA) participates in multilateral coalitions and initiatives that bring together the medicines regulatory authorities and pharmaceutical industry from around the world. The aim of these activities is to promote convergence of global standards, increase sharing of information and address common challenges.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "13/11/2023", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives" }, { "title": "WHO collaborative procedure for registering medicines through reliance", "summary": "Marketing authorisation holders can apply to make centrally authorised products available in countries participating in the World Health Organization (WHO) collaborative registration procedure, which is based on the principle of reliance. The procedure involves sharing assessments carried out by the European Medicines Agency (EMA) with those countries to streamline the approval process of medicines.", "categories": "", "first_published_date": "13/11/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/who-collaborative-procedure-registering-medicines-through-reliance" }, { "title": "Research and development (veterinary medicines)", "summary": "The European Medicines Agency (EMA) provides guidance and support to companies researching and developing veterinary medicines. This includes scientific and regulatory information on how to design and run clinical trials, compliance standards, how to establish maximum residue limits for medicines and biocides, support to innovation, and support the development of veterinary medicines for limited markets.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "09/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines" }, { "title": "Compliance: post-authorisation (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "10/05/2017", "last_updated_date": "09/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/compliance-post-authorisation-veterinary-medicines" }, { "title": "Compliance: marketing authorisation", "summary": "Marketing authorisation holders must ensure compliance with EU standards. European Medicines Agency (EMA) harmonises these standards across the EU and coordinates inspections. EMA’s scientific committees may request medicine samples for analysis during the approval process.", "categories": "", "first_published_date": "10/05/2017", "last_updated_date": "09/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation" }, { "title": "Referral procedures: veterinary medicines", "summary": "A veterinary referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines for veterinary use. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU).", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines" }, { "title": "Former EMA policy on minor use / minor species  (MUMS) / limited markets", "summary": "", "categories": "Veterinary", "first_published_date": "27/01/2022", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/veterinary-limited-markets/former-ema-policy-minor-use-minor-species-mums-limited-markets" }, { "title": "Immunologicals: guidelines", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/immunologicals-guidelines" }, { "title": "Efficacy guidelines", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/efficacy-guidelines" }, { "title": "Quality guidelines", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines" }, { "title": "Availability of veterinary vaccines", "summary": "Vaccination is one of the most effective tools for preventing animal diseases and for promoting animal health and welfare, safe food production and public health. Despite their importance, there are often challenges to ensuring that suitable veterinary vaccines are available in a timely manner on the European Union (EU) market. The European Medicines Agency (EMA) and its partners in the European medicines regulatory network are implementing an action plan to help increase the availability of veterinary vaccines in the EU.", "categories": "Veterinary", "first_published_date": "04/08/2016", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/availability-veterinary-vaccines" }, { "title": "Advice on impacts of using antimicrobials in animals", "summary": "The European Medicines Agency (EMA) is involved in monitoring and evaluating the risks of using antibiotics in animals. It has looked in particular at the risk of the development of antimicrobial resistance in animals and of the possible transmission of resistance to humans.", "categories": "Veterinary", "first_published_date": "29/04/2015", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/advice-impacts-using-antimicrobials-animals" }, { "title": "Legal framework: Pharmacovigilance", "summary": "", "categories": "Human", "first_published_date": "20/04/2011", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-framework-pharmacovigilance" }, { "title": "Advanced therapy medicinal products: Overview", "summary": "Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells. They offer groundbreaking new opportunities for the treatment of disease and injury.", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "08/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview" }, { "title": "Compliance: research and development", "summary": "", "categories": "", "first_published_date": "10/05/2017", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/compliance-research-development" }, { "title": "Risk management", "summary": "", "categories": "Human", "first_published_date": "05/01/2016", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pharmacovigilance-marketing-authorisation/risk-management" }, { "title": "Pharmacovigilance: marketing authorisation", "summary": "Applicants are responsible for ensuring the safety profile of their medicine is adequately characterised at the time of submitting their marketing authorisation application.", "categories": "", "first_published_date": "28/03/2017", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pharmacovigilance-marketing-authorisation" }, { "title": "Paediatric medicines: marketing authorisation", "summary": "This section provides information on the European Medicines Agency's activities relating to paediatric medicines during the marketing-authorisation-application stage.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/paediatric-medicines-marketing-authorisation" }, { "title": "Medicines for use outside the European Union", "summary": "The European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU).", "categories": "Human", "first_published_date": "24/05/2018", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/medicines-use-outside-european-union" }, { "title": "VICH GL60 Good manufacturing practice for active ingredients used in veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/11/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/vich-gl60-good-manufacturing-practice-active-ingredients-used-veterinary-medicinal-products-scientific-guideline" }, { "title": "Orphan designation: marketing authorisation", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all orphan medicines in the European Economic Area (EEA), as they fall under the mandatory scope of the centralised procedure.", "categories": "", "first_published_date": "01/12/2016", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/orphan-designation-marketing-authorisation" }, { "title": "Medicine shortages and availability issues: guidance for patients and healthcare professionals", "summary": "Guidance is available from the European Medicines Agency (EMA) on the measures that patient and healthcare professional organisations can take to help prevent and manage shortages of human medicines in the EU.", "categories": "Human;Veterinary", "first_published_date": "07/11/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-patients-healthcare-professionals" }, { "title": "Sampling and testing", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation/sampling-testing" }, { "title": "Compliance: marketing authorisation", "summary": "", "categories": "Veterinary", "first_published_date": "31/03/2017", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/compliance-marketing-authorisation" }, { "title": "Advanced therapies: marketing authorisation", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of marketing authorisation applications for all advanced therapy medicinal products (ATMPs) in the European Economic Area, as they fall under the mandatory scope of the centralised procedure.", "categories": "Human", "first_published_date": "09/02/2017", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation" }, { "title": "Marketing authorisation", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA). Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein.", "categories": "Human", "first_published_date": "03/05/2016", "last_updated_date": "07/11/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation" }, { "title": "Influenza vaccines - non-clinical and clinical module - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/07/2014", "last_updated_date": "31/10/2023", "general_url": "https://www.ema.europa.eu/en/influenza-vaccines-non-clinical-clinical-module-scientific-guideline" }, { "title": "DNA and host cell protein impurities, routine testing versus validation studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/06/1997", "last_updated_date": "19/10/2023", "general_url": "https://www.ema.europa.eu/en/dna-host-cell-protein-impurities-routine-testing-versus-validation-studies-scientific-guideline" }, { "title": "Quality guidelines: non-immunologicals", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "18/10/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines/quality-guidelines-non-immunologicals" }, { "title": "COVID-19 guidance: research and development", "summary": "", "categories": "Human", "first_published_date": "15/12/2020", "last_updated_date": "16/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/guidance-medicine-developers-and-other-stakeholders-covid-19/covid-19-guidance-research-development" }, { "title": "Quality, safety and efficacy of bacteriophages as veterinary medicines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "28/01/2022", "last_updated_date": "13/10/2023", "general_url": "https://www.ema.europa.eu/en/quality-safety-and-efficacy-bacteriophages-veterinary-medicines-scientific-guideline" }, { "title": "Buying medicines online", "summary": "In the European Union (EU), it is possible to buy medicines online. Patients should only buy medicines from online retailers registered with the national competent authorities in the EU Member States, to reduce the risk of buying sub-standard or falsified medicines. The European Commission has introduced a common logo that appears on the websites of these registered retailers.", "categories": "Human;Veterinary", "first_published_date": "01/07/2015", "last_updated_date": "13/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/falsified-medicines-overview/buying-medicines-online" }, { "title": "Medical Device Shortages SPOC Working Party meetings", "summary": "", "categories": "Human;Corporate", "first_published_date": "06/09/2023", "last_updated_date": "12/10/2023", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/medical-device-shortages-single-point-contact-spoc-working-party/medical-device-shortages-spoc-working-party-meetings" }, { "title": "Public data from Article 57 database", "summary": "", "categories": "Human", "first_published_date": "30/07/2018", "last_updated_date": "09/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database" }, { "title": "Modelling and simulation: questions and answers", "summary": "", "categories": "Human", "first_published_date": "21/11/2018", "last_updated_date": "06/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/clinical-pharmacology-pharmacokinetics/modelling-simulation-questions-answers" }, { "title": "ICH guideline E19 on a selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials - Scientific guideline", "summary": "This guideline provides internationally harmonised guidance on the use of selective safety data collection that may be applied in specific late-stage interventional clinical trials that may be pre-approval or post-approval.", "categories": "Human", "first_published_date": "29/03/2019", "last_updated_date": "06/10/2023", "general_url": "https://www.ema.europa.eu/en/ich-guideline-e19-selective-approach-safety-data-collection-specific-late-stage-pre-approval-or-post-approval-clinical-trials-scientific-guideline" }, { "title": "PRAC members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Pharmacovigilance Risk Assessment Committee (PRAC).", "categories": "Human", "first_published_date": "05/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac/prac-members" }, { "title": "PDCO members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Paediatric Committee (PDCO).", "categories": "Human", "first_published_date": "05/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/paediatric-committee-pdco/pdco-members" }, { "title": "Qualification of novel methodologies for medicine development", "summary": "The European Medicines Agency (EMA) offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals.", "categories": "Human", "first_published_date": "27/05/2020", "last_updated_date": "04/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/qualification-novel-methodologies-medicine-development" }, { "title": "HMPC members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee on Herbal Medicinal Products (HMPC).", "categories": "Herbal", "first_published_date": "04/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/committee-herbal-medicinal-products-hmpc/hmpc-members" }, { "title": "Pharmacogenomics Working Party", "summary": "", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/pharmacogenomics-working-party" }, { "title": "Pharmacokinetics Working Party", "summary": "", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/pharmacokinetics-working-party" }, { "title": "Safety Working Party", "summary": "", "categories": "Human;Corporate", "first_published_date": "04/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/safety-working-party" }, { "title": "Safety Working Party (SWP-V)", "summary": "The Safety Working Party (SWP-V) provides scientific expertise to the Committee for Veterinary Medicinal Products (CVMP) on all issues regarding the safety of veterinary medicinal products in the context of user and consumer safety, except for environmental risk assessment and target-animal safety.", "categories": "Veterinary", "first_published_date": "04/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/safety-working-party" }, { "title": "Inter-Committee Scientific Advisory Group on Oncology", "summary": "The Inter-Committee Scientific Advisory Group on Oncology (IC-SAG) is convened at the request of any of the European Medicines Agency (EMA) committees to provide independent recommendations on scientific or technical matters. These relate to paediatric and adult clinical oncology and haematology, or to any other scientific issue relevant to the work of EMA that relates to this area.", "categories": "Human;Herbal", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/inter-committee-scientific-advisory-group-oncology" }, { "title": "Working Party on European Union Monographs and European Union List", "summary": "", "categories": "Herbal", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/hmpc/working-party-european-union-monographs-european-union-list" }, { "title": "Organisational Matters Drafting Group", "summary": "", "categories": "Herbal", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/hmpc/organisational-matters-drafting-group" }, { "title": "Immunologicals Working Party", "summary": "The Immunologicals Working Party (IWP) provides recommendations to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating directly or indirectly to immunological veterinary medicinal products (IVMPs).", "categories": "Veterinary", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/immunologicals-working-party" }, { "title": "Novel Therapies and Technologies Working Party", "summary": "The Novel Therapies and Technologies Working Party (NTWP) provides recommendations to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating to veterinary novel therapies and technologies.", "categories": "Veterinary", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/novel-therapies-technologies-working-party" }, { "title": "Pharmacovigilance Working Party", "summary": "The Pharmacovigilance Working Party (PhVWP-V) provides advice to the Committee for Veterinary Medicinal Products (CVMP) on the co-ordination and supervision of the pharmacovigilance of centrally authorised veterinary medicines. It also provides advice on medicines authorised nationally and through the mutual recognition/decentralised procedure.", "categories": "Veterinary", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/pharmacovigilance-working-party" }, { "title": "Working Group on Quality Review of Documents", "summary": "The Working Group on Quality Review of Documents (QRD) provides assistance to the European Medicines Agency's scientific committees and to companies on linguistic aspects of the product information for medicines. This includes summaries of product characteristics, labelling and package leaflets.", "categories": "Human;Veterinary", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/working-group-quality-review-documents" }, { "title": "Geriatric Expert Group", "summary": "The Geriatric Expert Group (GEG) provides scientific advice to the Committee for Medicinal Products for Human Use (CHMP) and the European Medicines Agency secretariat on issues related to the elderly.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/geriatric-expert-group" }, { "title": "Scientific Advisory Group on Cardiovascular Issues", "summary": "The Scientific Advisory Group on Cardiovascular Issues (SAG-CVS) is convened at the request of the Committee for Medicinal Products for Human Use (CHMP) to provide independent recommendations on scientific or technical matters relating to cardiovascular products under evaluation by the CHMP, or on any other scientific issue relevant to the work of the CHMP that relates to this area.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advisory-group-cardiovascular-issues" }, { "title": "Scientific Advisory Group on Neurology", "summary": "The Scientific Advisory Group on Neurology (SAG-N) is convened at the request of EMA's Committee for Medicinal Products for Human Use (CHMP) to provide independent recommendations. They are related to scientific or technical matters on neurology products under evaluation by the CHMP, or on any other scientific issue relevant to the work of the CHMP that relates to this area.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advisory-group-neurology" }, { "title": "Biostatistics Operational Expert Group", "summary": "The Biostatistics Operational Expert Group (BSOEG) provides regular product-related support to the European Medicines Agency's (EMA) Scientific Advice Working Party on clinical trial methodology and statistical topics.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/biostatistics-operational-expert-group" }, { "title": "Modelling and Simulation Operational Expert Group", "summary": "The Modelling and Simulation Operational Expert Group (MSOEG) provides product-related support to the European Medicines Agency's (EMA) scientific committees and to its Scientific Advice Working Party.", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/modelling-simulation-operational-expert-group" }, { "title": "Summary of Product Characteristics Advisory Group", "summary": "The Summary of Product Characteristics Advisory Group (SmPC AG) promotes and facilitates the application of the guideline on summary of product characteristics (SmPC).", "categories": "Human", "first_published_date": "03/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/summary-product-characteristics-advisory-group" }, { "title": "Haematology European Specialised Expert Community", "summary": "The Haematology European Specialised Expert Community (ESEC) is a platform for information-sharing among European experts on scientific and regulatory topics related to haematology (non-malignant).", "categories": "Human", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/haematology-european-specialised-expert-community" }, { "title": "Scientific Advice Working Party", "summary": "The Scientific Advice Working Party (SAWP) is a standing working party with the sole remit of providing scientific advice and protocol assistance. It was established by the Committee for Medicinal Products for Human Use (CHMP).", "categories": "Human", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/scientific-advice-working-party" }, { "title": "Non-Clinical and New Approach Methodologies European Specialised Expert Community", "summary": "", "categories": "Human;Veterinary", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/non-clinical-new-approach-methodologies-european-specialised-expert-community" }, { "title": "Oncology European Specialised Expert Community", "summary": "The Oncology European Specialised Expert Community (ESEC) is a platform for information-sharing among European experts on scientific and regulatory topics related to oncology. ", "categories": "Human", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/oncology-european-specialised-expert-community" }, { "title": "Cardiovascular Diseases European Specialised Expert Community", "summary": "The Cardiovascular Diseases European Specialised Expert Community (ESEC) is a platform for information-sharing among European experts on scientific and regulatory topics related to cardiovascular diseases, obesity and diabetes.", "categories": "Human", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/cardiovascular-diseases-european-specialised-expert-community" }, { "title": "Management Board members", "summary": "The European Medicines Agency (EMA) publishes details of the members of its Management Board.", "categories": "Corporate", "first_published_date": "02/10/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/management-board/members" }, { "title": "Risk management plans", "summary": "Companies are required submit a risk-management plan (RMP) to the European Medicines Agency (EMA) when applying for a marketing authorisation. To help applicants, guidance is available on how to submit RMPs.", "categories": "Human", "first_published_date": "17/04/2013", "last_updated_date": "02/10/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pharmacovigilance-marketing-authorisation/risk-management/risk-management-plans" }, { "title": "Medical Device Shortages SPOC Working Party meetings", "summary": "", "categories": "Human;Corporate", "first_published_date": "28/09/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/medical-device-shortages-single-point-contact-spoc-working-party/meetings" }, { "title": "Medical Device Shortages Single Point of Contact (SPOC) Working Party", "summary": "The Medical Device Shortages Single Point of Contact (SPOC) Working Party is responsible for monitoring and reporting events that could affect the supply of medical devices in the European Union (EU) during a public health emergency.", "categories": "Human", "first_published_date": "28/09/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/medical-device-shortages-single-point-contact-spoc-working-party" }, { "title": "How to find us", "summary": "The European Medicines Agency's office is located in Amsterdam. Find guidance on how to get to the building and plan your visit to our office and information on the building's accessibility. For post and deliveries, we have two separate addresses.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "26/09/2023", "general_url": "https://www.ema.europa.eu/en/about-us/contacts-european-medicines-agency/how-find-us" }, { "title": "RSS feeds", "summary": "The European Medicines Agency's (EMA) RSS feeds allow you to stay up to date with the latest news and features you are interested in from this website.", "categories": "", "first_published_date": "25/09/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/news-events/rss-feeds" }, { "title": "Good clinical practice (GCP) inspection procedures", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "22/09/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice/good-clinical-practice-gcp-inspection-procedures" }, { "title": "User safety of topically administered products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/03/2014", "last_updated_date": "15/09/2023", "general_url": "https://www.ema.europa.eu/en/user-safety-topically-administered-products-scientific-guideline" }, { "title": "United States", "summary": "The European Commission, the European Medicines Agency (EMA) and the United States of America (USA) Food and Drug Administration (FDA) work together in many areas, streamlining efforts, sharing best practices and aiming to avoid duplication to promote human and animal health. Confidentiality arrangements facilitate this collaboration.", "categories": "Corporate", "first_published_date": "12/08/2015", "last_updated_date": "12/09/2023", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/united-states" }, { "title": "COVID-19 public health emergency of international concern (2020-23)", "summary": "During the COVID-19 public health emergency, between 2020 and 2023, the European Medicines Agency (EMA) enabled the development and authorisation of safe and effective treatments and vaccines in the European Union (EU). The Agency monitored the safety of these medicines, worked on the response with regulators across the world, and provided reliable, timely and openly-accessible information.", "categories": "Human", "first_published_date": "30/08/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23" }, { "title": "How to prepare and review a summary of product characteristics", "summary": "This page includes guidance for pharmaceutical companies and regulators on how to prepare and review summaries of product characteristics (SmPCs) for human medicines.", "categories": "Human", "first_published_date": "21/01/2013", "last_updated_date": "30/08/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/how-prepare-review-summary-product-characteristics" }, { "title": "10 years of the Healthcare Professionals' Working Party", "summary": "", "categories": "Human;Corporate", "first_published_date": "18/08/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/working-parties-and-other-groups/chmp-working-parties-and-other-groups/healthcare-professionals-working-party/10-years-healthcare-professionals-working-party" }, { "title": "Pharmacovigilance (veterinary medicines)", "summary": "Veterinary pharmacovigilance involves closely monitoring the safety and efficacy of veterinary medicines on the European Union (EU) market. The European Medicines Agency (EMA) has a coordinating role in the EU pharmacovigilance system and operates services and processes to support veterinary pharmacovigilance activities. EMA also provides guidance and recommendations to stakeholders on the safe and effective use of veterinary medicines.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "17/08/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines" }, { "title": "Development of a reflection paper on modern manufacturing techniques used for herbal preparations - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "17/08/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/development-reflection-paper-modern-manufacturing-techniques-used-herbal-preparations-scientific-guideline" }, { "title": "Certification procedures for advanced therapies under development by micro-, small- and medium-sized enterprises (SMEs)", "summary": "The European Medicines Agency's Committee for Advanced Therapies (CAT) provides a certification procedure for advanced therapy medicinal products (ATMPs) under development by micro-, small- and medium-sized enterprises (SMEs). This is an opportunity for SMEs to get an assessment of the data they have generated and check that they are on the right track for successful development.", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "31/07/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/certification-procedures-advanced-therapies-under-development-micro-small-medium-sized-enterprises-smes" }, { "title": "Accelerated assessment", "summary": "Accelerated assessment reduces the timeframe for the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to review a marketing-authorisation application. Applications may be eligible for accelerated assessment if the CHMP decides the product is of major interest for public health and therapeutic innovation.", "categories": "Human", "first_published_date": "01/03/2016", "last_updated_date": "31/07/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/accelerated-assessment" }, { "title": "Obtaining an EU marketing authorisation, step-by-step", "summary": "The European Medicines Agency (EMA) is responsible for the scientific evaluation of applications for centralised marketing authorisations in the European Union (EU). This authorisation procedure allows pharmaceutical companies to submit a single marketing authorisation application to EMA and to market the medicine and make it available to patients and healthcare professionals throughout the European Economic Area on the basis of a single marketing authorisation.", "categories": "", "first_published_date": "03/07/2019", "last_updated_date": "31/07/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/obtaining-eu-marketing-authorisation-step-step" }, { "title": "Medicines for older people", "summary": "The European Medicines Agency (EMA) plays an important role in ensuring that the needs of older people are taken into account in the development, approval and use of medicines in the European Union (EU). This includes developing guidelines on how to address the specific requirements of older patients in medicine development programmes and improving the provision of information for those patients.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/07/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/medicines-older-people" }, { "title": "Procedural timetables", "summary": "This page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures.", "categories": "Human", "first_published_date": "11/07/2011", "last_updated_date": "25/07/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/submission-dates/procedural-timetables" }, { "title": "Requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/09/2015", "last_updated_date": "21/07/2023", "general_url": "https://www.ema.europa.eu/en/requirements-quality-production-control-safety-efficacy-allergen-products-use-horses-dogs-cats-scientific-guideline" }, { "title": "Quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/07/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/quality-data-requirements-applications-veterinary-medicinal-products-other-biologicals-intended-limited-markets-scientific-guideline" }, { "title": "Development, production, characterisation and specifications for monoclonal antibodies and related products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2008", "last_updated_date": "21/07/2023", "general_url": "https://www.ema.europa.eu/en/development-production-characterisation-specifications-monoclonal-antibodies-related-products-scientific-guideline" }, { "title": "Availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/07/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/availability-characteristics-diagnostic-tests-improve-responsible-use-antibiotics-animals-scientific-guideline" }, { "title": "Stability testing of existing active substances and related finished products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "05/08/2008", "last_updated_date": "21/07/2023", "general_url": "https://www.ema.europa.eu/en/stability-testing-existing-active-substances-related-finished-products-scientific-guideline" }, { "title": "Excipients in the dossier for application for marketing authorisation for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/02/1999", "last_updated_date": "21/07/2023", "general_url": "https://www.ema.europa.eu/en/excipients-dossier-application-marketing-authorisation-veterinary-medicinal-products-scientific-guideline" }, { "title": "ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/09/2014", "last_updated_date": "19/07/2023", "general_url": "https://www.ema.europa.eu/en/ich-m7-assessment-control-dna-reactive-mutagenic-impurities-pharmaceuticals-limit-potential-carcinogenic-risk-scientific-guideline" }, { "title": "Multidisciplinary guidelines: artificial intelligence (AI)", "summary": "The European Medicines Agency's scientific guidelines on artificial intelligence help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "19/07/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-artificial-intelligence-ai" }, { "title": "Multidisciplinary guidelines: patient experience data (PED)", "summary": "The European Medicines Agency's (EMA) multidisciplinary guidelines on patient experience data (PED) provide guidance to medicine developers and other stakeholders.", "categories": "Human", "first_published_date": "19/07/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-patient-experience-data-ped" }, { "title": "Incident management plan (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "15/07/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/incident-management-plan-veterinary-medicines" }, { "title": "Veterinary Medicinal Products Regulation", "summary": "The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) updated the rules on the authorisation and use of veterinary medicines in the European Union (EU) when it became applicable on 28 January 2022. The European Medicines Agency (EMA) works with the European Commission and other EU partners in implementing the Regulation.", "categories": "Veterinary", "first_published_date": "23/09/2019", "last_updated_date": "07/07/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation" }, { "title": "Procurement activities 2022", "summary": "This page is an archive of the European Medicines Agency's tenders from 2022 with a value over the threshold of the Public Procurement Directive 2014/24/EU whose application deadline has passed.", "categories": "Corporate", "first_published_date": "03/05/2022", "last_updated_date": "30/06/2023", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2022" }, { "title": "EU Network Training Centre (EU NTC)", "summary": "The European Union Network Training Centre (EU NTC) is a platform offering training opportunities to the staff of medicines regulatory authorities in the European medicines regulatory network, in the fields of human and veterinary medicines. It is overseen by the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA).", "categories": "Corporate", "first_published_date": "26/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network/eu-network-training-centre-eu-ntc" }, { "title": "Procurement activities 2023", "summary": "This page is an archive of the European Medicines Agency's tenders from 2023 with a value over the threshold of the Public Procurement Directive 2014/24/EU whose application deadline has passed.", "categories": "Corporate", "first_published_date": "25/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2023" }, { "title": "Procurement and grant activities 2024", "summary": "This page is an archive of the European Medicines Agency's tenders from 2024 with a value over the threshold of the Public Procurement Directive 2014/24/EU whose application deadline has passed.", "categories": "Corporate", "first_published_date": "25/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-grant-activities-2024" }, { "title": "Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/04/2018", "last_updated_date": "23/06/2023", "general_url": "https://www.ema.europa.eu/en/guideline-summary-product-characteristics-spc-veterinary-medicinal-products-containing-antimicrobial-substances-scientific-guideline" }, { "title": "Implementation of the pharmacovigilance legislation", "summary": "", "categories": "Human", "first_published_date": "21/02/2012", "last_updated_date": "22/06/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-framework-pharmacovigilance/implementation-pharmacovigilance-legislation" }, { "title": "Article 5(3) opinions on any scientific matter: human medicines", "summary": "This page lists the opinions drawn up by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) under Article 5(3) of the Regulation establishing the EMA, concerning any scientific matter related to the evaluation of medicines for use in humans.", "categories": "Human", "first_published_date": "14/10/2010", "last_updated_date": "22/06/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/article-53-opinions-any-scientific-matter-human-medicines" }, { "title": "Executive Steering Group on Shortages of Medical Devices (MDSSG) meetings", "summary": "", "categories": "Human;Corporate", "first_published_date": "15/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steering-group-shortages-medical-devices/executive-steering-group-shortages-medical-devices-mdssg-meetings" }, { "title": "Use of herbal medicinal products containing estragole - Scientific guideline", "summary": "", "categories": "Herbal", "first_published_date": "23/11/2005", "last_updated_date": "09/06/2023", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-estragole-scientific-guideline" }, { "title": "Medicine Shortages SPOC Working Party meetings", "summary": "The Medicine Shortages Single Point of Contact (SPOC) Working Party meets once a month. It shares information on shortages and availability issues of human and veterinary medicines and coordinates actions to prevent and manage shortages.", "categories": "Human;Corporate", "first_published_date": "30/03/2023", "last_updated_date": "07/06/2023", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/medicines-shortages-single-point-contact-spoc-working-party/medicine-shortages-spoc-working-party-meetings" }, { "title": "COVID-19 medicines that received EMA advice", "summary": "During the COVID-19 pandemic, the European Medicines Agency (EMA) interacted with developers of potential COVID-19 vaccines and treatments to enable their distribution in the European Union (EU) as soon as possible.\r\n\r\nThe outcome of any consultation or advice from EMA was not binding on developers.", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-medicines-received-ema-advice" }, { "title": "Press briefings and stakeholder meetings", "summary": "", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/press-briefings-and-stakeholder-meetings" }, { "title": "COVID-19 medicines: Article 18 and Article 5(3) reviews", "summary": "The European Medicines Agency (EMA) may review COVID-19 vaccines and treatments under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-medicines-article-18-article-53-reviews" }, { "title": "COVID-19 medicines under evaluation", "summary": "The European Medicines Agency (EMA) is evaluating potential COVID-19 vaccines and treatments to enable promising medicines to reach patients in the European Union (EU) as soon as possible.", "categories": "Human", "first_published_date": "06/06/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-medicines-under-evaluation" }, { "title": "COVID-19: latest updates (archive)", "summary": "", "categories": "Human;Corporate", "first_published_date": "11/04/2020", "last_updated_date": "05/06/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-latest-updates-archive" }, { "title": "Article 5 procedure: Regulatory and procedural guidance", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/06/2010", "last_updated_date": "31/05/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/article-5-procedure-regulatory-procedural-guidance" }, { "title": "Archived versions of the European Medicines Agency's website", "summary": "It is possible to access earlier versions of the European Medicines Agency's (EMA) website via an online archive maintained by the Publications Office of the European Union. Website versions go back to December 2009. ", "categories": "Corporate", "first_published_date": "23/05/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/archived-versions-european-medicines-agencys-website" }, { "title": "ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for human pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/09/1993", "last_updated_date": "22/05/2023", "general_url": "https://www.ema.europa.eu/en/ich-s5-r3-guideline-detection-reproductive-developmental-toxicity-human-pharmaceuticals-scientific-guideline" }, { "title": "Buying veterinary medicines online", "summary": "It is possible to buy veterinary medicines online in the European Union (EU). Veterinarians, farmers and pet owners should only buy from online retailers registered with the national competent authorities in the EU Member States, to reduce the risk of buying sub-standard medicines. The European Commission has introduced a common logo that appears on the websites of these registered retailers.", "categories": "Veterinary", "first_published_date": "28/01/2022", "last_updated_date": "12/05/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/buying-veterinary-medicines-online" }, { "title": "Patients' and Consumers' Working Party meetings", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "10/05/2023", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers/patients-consumers-working-party-meetings" }, { "title": "Healthcare Professionals' Working Party meetings", "summary": "", "categories": "Human", "first_published_date": "09/07/2013", "last_updated_date": "10/05/2023", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/healthcare-professionals-working-party/healthcare-professionals-working-party-meetings" }, { "title": "Good clinical practice", "summary": "Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "04/05/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-clinical-practice" }, { "title": "Legal framework: orphan designation", "summary": "This page summarises the legal background to the procedure for orphan designation in the European Union (EU). It includes the key milestones in EU legislation adopted since the Orphan Regulation was first adopted in 1999.", "categories": "Human", "first_published_date": "18/12/2012", "last_updated_date": "24/04/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/orphan-designation-overview/legal-framework-orphan-designation" }, { "title": "Regulatory science strategy", "summary": "The European Medicines Agency's (EMA) 'Regulatory Science to 2025' strategy is a plan for advancing EMA's engagement with regulatory science over the next five to ten years, covering both human and veterinary medicines. The strategy aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine. EMA consulted with stakeholders on the draft strategy via a public consultation and dedicated workshops.", "categories": "Human;Veterinary;Corporate", "first_published_date": "11/12/2018", "last_updated_date": "24/04/2023", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-strategy" }, { "title": "ICH guideline S12 on nonclinical biodistribution considerations for gene therapy products - Step 2b - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/06/2021", "last_updated_date": "20/04/2023", "general_url": "https://www.ema.europa.eu/en/ich-guideline-s12-nonclinical-biodistribution-considerations-gene-therapy-products-step-2b-scientific-guideline" }, { "title": "Exemptions to labelling and package-leaflet obligations", "summary": "", "categories": "Human", "first_published_date": "19/08/2014", "last_updated_date": "19/04/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/exemptions-labelling-package-leaflet-obligations" }, { "title": "Availability of medicines during COVID-19", "summary": "The European Medicines Agency (EMA) and its partners in the European medicines regulatory network put measures in place to help prevent and mitigate possible disruptions to the supply of medicines in the European Union (EU) caused by COVID-19. Extraordinarily, EMA has acted as central coordinator in supporting Member States' activities in this area during the pandemic.", "categories": "Human", "first_published_date": "17/04/2020", "last_updated_date": "19/04/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/availability-medicines-during-covid-19" }, { "title": "Non-clinical Working Party documents", "summary": "", "categories": "Human", "first_published_date": "24/11/2009", "last_updated_date": "05/04/2023", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/non-clinical-working-party/non-clinical-working-party-documents" }, { "title": "Events", "summary": "Search EMA's events", "categories": "", "first_published_date": "27/01/2023", "last_updated_date": "28/03/2023", "general_url": "https://www.ema.europa.eu/en/events/upcoming-events" }, { "title": "ICH Q5A(R2) Guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/10/1997", "last_updated_date": "27/03/2023", "general_url": "https://www.ema.europa.eu/en/ich-q5ar2-guideline-viral-safety-evaluation-biotechnology-products-derived-cell-lines-human-or-animal-origin-scientific-guideline" }, { "title": "Referral procedures: human medicines", "summary": "A referral is a procedure used to resolve issues such as concerns over the safety or benefit-risk balance of a medicine or a class of medicines. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union (EU).", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "24/03/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines" }, { "title": "Joint Audit Programme", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "14/03/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/joint-audit-programme" }, { "title": "Authenticity verification electronic certificates", "summary": "", "categories": "", "first_published_date": "27/02/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/authenticity-verification-electronic-certificates" }, { "title": "Veterinary medicine shortages and availability issues", "summary": "", "categories": "Veterinary", "first_published_date": "23/08/2018", "last_updated_date": "23/02/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/veterinary-medicine-shortages-availability-issues" }, { "title": "Quality of modified release dosage forms for veterinary use - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/07/2003", "last_updated_date": "20/02/2023", "general_url": "https://www.ema.europa.eu/en/quality-modified-release-dosage-forms-veterinary-use-scientific-guideline" }, { "title": "Declaration of storage conditions: 1. in the product information of pharmaceutical veterinary medicinal products, 2. for active substances (Annex) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2007", "last_updated_date": "20/02/2023", "general_url": "https://www.ema.europa.eu/en/declaration-storage-conditions-1-product-information-pharmaceutical-veterinary-medicinal-products-2-active-substances-annex-scientific-guideline" }, { "title": "Quality aspects of single-dose veterinary spot-on products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "11/02/2009", "last_updated_date": "20/02/2023", "general_url": "https://www.ema.europa.eu/en/quality-aspects-single-dose-veterinary-spot-products-scientific-guideline" }, { "title": "Additional quality requirements for products intended for incorporation into animal feeding-stuffs (medicated premixes) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/12/1996", "last_updated_date": "20/02/2023", "general_url": "https://www.ema.europa.eu/en/additional-quality-requirements-products-intended-incorporation-animal-feeding-stuffs-medicated-premixes-scientific-guideline" }, { "title": "Parametric release - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/07/2016", "last_updated_date": "17/02/2023", "general_url": "https://www.ema.europa.eu/en/parametric-release-scientific-guideline" }, { "title": "Control of impurities of pharmacopoeial substances: compliance with the European Pharmacopoeia general monograph “Substances for Pharmaceutical Use” and general chapter “Control of Impurities in Substances for Pharmaceutical Use” - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/03/2004", "last_updated_date": "17/02/2023", "general_url": "https://www.ema.europa.eu/en/control-impurities-pharmacopoeial-substances-compliance-european-pharmacopoeia-general-monograph-substances-pharmaceutical-use-general-chapter-control-impurities-substances-pharmaceutical-use" }, { "title": "Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Veterinary - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/11/2016", "last_updated_date": "17/02/2023", "general_url": "https://www.ema.europa.eu/en/chemical-structure-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances-veterinary-scientific-guideline" }, { "title": "Development pharmaceutics for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/08/1999", "last_updated_date": "17/02/2023", "general_url": "https://www.ema.europa.eu/en/development-pharmaceutics-veterinary-medicinal-products-scientific-guideline" }, { "title": "Chemistry of active substances for veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/10/2015", "last_updated_date": "17/02/2023", "general_url": "https://www.ema.europa.eu/en/chemistry-active-substances-veterinary-medicinal-products-scientific-guideline" }, { "title": "Adjuvants in vaccines for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/01/2005", "last_updated_date": "16/02/2023", "general_url": "https://www.ema.europa.eu/en/adjuvants-vaccines-human-use-scientific-guideline" }, { "title": "Herbal medicinal products: questions and answers", "summary": "This page addresses questions that have previously been submitted by pharmaceutical companies seeking market access to a European Union Member State for their herbal medicinal product.", "categories": "Herbal", "first_published_date": "01/12/2016", "last_updated_date": "15/02/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/herbal-medicinal-products-questions-answers" }, { "title": "Need for a paediatric addendum of the guideline on clinical investigation of medicinal products for the treatment and prophylaxis of venous thromboembolic disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/10/2017", "last_updated_date": "14/02/2023", "general_url": "https://www.ema.europa.eu/en/need-paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-prophylaxis-venous-thromboembolic-disease-scientific-guideline" }, { "title": "ICH Q9 Quality risk management - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/01/2006", "last_updated_date": "06/02/2023", "general_url": "https://www.ema.europa.eu/en/ich-q9-quality-risk-management-scientific-guideline" }, { "title": "Crisis preparedness and management", "summary": "The European Medicines Agency (EMA) has a formal role in preparing for and managing crisis situations affecting the European Union (EU) single market for medicines and medical devices, based on legislation that took effect on 1 March 2022.", "categories": "Human", "first_published_date": "01/03/2022", "last_updated_date": "02/02/2023", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management" }, { "title": "International collaboration on GMP inspections", "summary": "", "categories": "Human", "first_published_date": "28/09/2017", "last_updated_date": "01/02/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice/international-collaboration-gmp-inspections" }, { "title": "Open consultations", "summary": "The list below includes the European Medicines Agency's (EMA) open public consultations.", "categories": "Human;Veterinary;Herbal", "first_published_date": "27/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/news-events/open-consultations" }, { "title": "Safety and residues: pharmaceutical guidelines", "summary": "EMA's scientific guidelines on the safety and residues of veterinary medicinal products help medicine developers prepare marketing authorisation applications.", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "27/01/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines/safety-residues-pharmaceutical-guidelines" }, { "title": "Guidance for the application of Article 34 of Regulation (EU) 2019/6 - prescription status", "summary": "", "categories": "Veterinary", "first_published_date": "25/03/2022", "last_updated_date": "27/01/2023", "general_url": "https://www.ema.europa.eu/en/guidance-application-article-34-regulation-eu-2019-6-prescription-status" }, { "title": "Events", "summary": "", "categories": "", "first_published_date": "27/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/events/past-events" }, { "title": "Glossary of regulatory terms", "summary": "EMA's glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in EMA documents.", "categories": "", "first_published_date": "20/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/glossaries/glossary-regulatory-terms" }, { "title": "Medical terms simplifier", "summary": "EMA’s medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for material prepared for the public.", "categories": "", "first_published_date": "20/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/glossaries/medical-terms-simplifier" }, { "title": "Glossaries", "summary": "The medical terms simplifier gives plain-language descriptions of medical terms commonly used in information about medicines. The glossary of regulatory terms gives definitions for the main regulatory terms used on this website and in EMA documents.", "categories": "", "first_published_date": "20/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/glossaries" }, { "title": "Changing the name or address of a sponsor", "summary": "", "categories": "Human", "first_published_date": "19/05/2015", "last_updated_date": "20/01/2023", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/orphan-designation-research-and-development/changing-name-or-address-sponsor" }, { "title": "Changing the (invented) name of a veterinary medicine", "summary": "", "categories": "Veterinary", "first_published_date": "16/12/2010", "last_updated_date": "12/01/2023", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/changing-invented-name-veterinary-medicine" }, { "title": "Page or document not found", "summary": "We are sorry, but the content you tried to access is unavailable at the link you used, which was either incorrect or out-of-date. To help you find what you are looking for, we have included some useful tips.", "categories": "", "first_published_date": "11/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/error-404" }, { "title": "Page or document unavailable", "summary": "We are sorry, but the page or document you tried to access is unavailable at the link you used.", "categories": "", "first_published_date": "11/01/2023", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/error-403" }, { "title": "ICH guideline Q13 on continuous manufacturing of drug substances and drug products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/2021", "last_updated_date": "06/01/2023", "general_url": "https://www.ema.europa.eu/en/ich-guideline-q13-continuous-manufacturing-drug-substances-and-drug-products-scientific-guideline" }, { "title": "Efficacy: pharmaceuticals", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "16/12/2022", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/efficacy-guidelines/efficacy-pharmaceuticals" }, { "title": "Summary of product characteristics for antiparasitic veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/12/2017", "last_updated_date": "16/12/2022", "general_url": "https://www.ema.europa.eu/en/summary-product-characteristics-antiparasitic-veterinary-medicinal-products-scientific-guideline" }, { "title": "Lanreotide acetate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/05/2022", "last_updated_date": "16/12/2022", "general_url": "https://www.ema.europa.eu/en/lanreotide-acetate-product-specific-bioequivalence-guidance" }, { "title": "ICH E8 General considerations for clinical studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/1998", "last_updated_date": "02/12/2022", "general_url": "https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline" }, { "title": "Pharmacovigilance inspection procedures: human", "summary": "European Union pharmacovigilance inspectors have developed Union procedures and guidance on pharmacovigilance inspections of marketing-authorisation holders of human and veterinary medicines.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "29/11/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation/pharmacovigilance-inspections-veterinary-medicines/pharmacovigilance-inspection-procedures-human" }, { "title": "Reflection paper on the application of Regulation (EU) 2019/6 for certain categories of variations", "summary": "", "categories": "Veterinary", "first_published_date": "20/07/2020", "last_updated_date": "24/11/2022", "general_url": "https://www.ema.europa.eu/en/reflection-paper-application-regulation-eu-2019-6-certain-categories-variations" }, { "title": "Guidance for medicine developers and other stakeholders on COVID-19", "summary": "During the 2020-23 COVID-19 public health emergency, the European Medicines Agency (EMA) provided guidance for medicine developers and pharmaceutical companies to help speed up development and approval for COVID-19 medicines and address regulatory challenges arising from the pandemic.", "categories": "Human", "first_published_date": "17/04/2020", "last_updated_date": "21/11/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/guidance-medicine-developers-other-stakeholders-covid-19" }, { "title": "Development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "28/01/2022", "last_updated_date": "18/11/2022", "general_url": "https://www.ema.europa.eu/en/development-data-requirements-potency-tests-cell-based-therapy-products-relation-clinical-efficacy" }, { "title": "Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances", "summary": "", "categories": "Human", "first_published_date": "18/11/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/criteria-be-considered-evaluation-new-active-substance-nas-status-biological-substances" }, { "title": "Platform trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/11/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/platform-trials-scientific-guideline" }, { "title": "Marketing-authorisation procedures for advanced-therapy medicinal products", "summary": "", "categories": "Human", "first_published_date": "05/05/2015", "last_updated_date": "10/11/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/advanced-therapies-marketing-authorisation/marketing-authorisation-procedures-advanced-therapy-medicinal-products" }, { "title": "Assessment of genotoxicity of herbal substances/preparations - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "11/05/2008", "last_updated_date": "31/10/2022", "general_url": "https://www.ema.europa.eu/en/assessment-genotoxicity-herbal-substances-preparations-scientific-guideline" }, { "title": "Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/07/2021", "last_updated_date": "26/10/2022", "general_url": "https://www.ema.europa.eu/en/guideline-core-smpc-labelling-and-package-leaflet-advanced-therapy-medicinal-products-atmps-containing-genetically-modified-cells-scientific-guideline" }, { "title": "Bioanalytical method validation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/08/2011", "last_updated_date": "25/10/2022", "general_url": "https://www.ema.europa.eu/en/bioanalytical-method-validation-scientific-guideline" }, { "title": "ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/09/1997", "last_updated_date": "10/10/2022", "general_url": "https://www.ema.europa.eu/en/ich-guideline-s1br1-testing-carcinogenicity-pharmaceuticals-scientific-guideline" }, { "title": "COVID-19 vaccines: studies for approval", "summary": "The European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA only recommends approval of a vaccine for COVID-19 after a thorough evaluation demonstrating the same high standards of quality, safety and efficacy required for any other vaccine approved in the EU.", "categories": "Human", "first_published_date": "11/12/2020", "last_updated_date": "06/10/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-studies-approval" }, { "title": "Antimicrobial-resistance surveillance as post-marketing authorisation commitment - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/10/2008", "last_updated_date": "16/09/2022", "general_url": "https://www.ema.europa.eu/en/antimicrobial-resistance-surveillance-post-marketing-authorisation-commitment-scientific-guideline" }, { "title": "Mpox (monkeypox)", "summary": "", "categories": "Human", "first_published_date": "28/06/2022", "last_updated_date": "22/08/2022", "general_url": "https://www.ema.europa.eu/en/mpox-monkeypox" }, { "title": "Direct animal healthcare professional communications", "summary": "", "categories": "Veterinary", "first_published_date": "11/08/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/direct-animal-healthcare-professional-communications" }, { "title": "Boric acid and borates - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/08/2015", "last_updated_date": "28/07/2022", "general_url": "https://www.ema.europa.eu/en/boric-acid-borates-scientific-guideline" }, { "title": "Management Board meetings", "summary": "The Management Board generally meets four times a year. The European Medicines Agency publishes the agendas and minutes of the meetings of the Management Board as well as related meeting documents, when available, on the meeting pages.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "21/07/2022", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/management-board-meetings" }, { "title": "Guidance documents related to data submission for authorised medicines", "summary": "", "categories": "Human", "first_published_date": "01/09/2011", "last_updated_date": "19/07/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/reporting-requirements-marketing-authorisation-holders/guidance-documents-related-data-submission-authorised-medicines" }, { "title": "EudraVigilance: security principles and responsibilities", "summary": "The EudraVigilance system contains multiple components using a range of technologies. While the European Medicines Agency (EMA) has put in place adequate measures to prevent, detect and address any potential security incidents, including personal data breaches, all authorised users need to cooperate in ensuring the security of EudraVigilance, in line with their legal obligations.", "categories": "Human", "first_published_date": "19/04/2017", "last_updated_date": "18/07/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/eudravigilance-security-principles-responsibilities" }, { "title": "Reflection paper on the use of measurable residual disease as a clinical endpoint in multiple myeloma studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/08/2018", "last_updated_date": "12/07/2022", "general_url": "https://www.ema.europa.eu/en/reflection-paper-use-measurable-residual-disease-clinical-endpoint-multiple-myeloma-studies-scientific-guideline" }, { "title": "Mock-ups and specimens", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "12/07/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/mock-ups-specimens" }, { "title": "Public consultation: Draft report on the development of a harmonised approach to exposure assessment methodologies for residues from veterinary medicinal products, feed additives and pesticides in food of animal origin", "summary": "", "categories": "Veterinary", "first_published_date": "30/06/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/public-consultation-draft-report-development-harmonised-approach-exposure-assessment-methodologies-residues-veterinary-medicinal-products-feed-additives-and-pesticides-food-animal-origin" }, { "title": "Procurement activities 2021", "summary": "This page is an archive of the European Medicines Agency's tenders from 2021 with a value over the threshold of the Public Procurement Directive 2014/24/EU whose application deadline has passed.", "categories": "Corporate", "first_published_date": "30/06/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2021" }, { "title": "Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/06/2012", "last_updated_date": "28/06/2022", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-or-prevention-diabetes-mellitus-scientific-guideline" }, { "title": "Olaparib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "16/12/2021", "last_updated_date": "27/06/2022", "general_url": "https://www.ema.europa.eu/en/olaparib-product-specific-bioequivalence-guidance" }, { "title": "Ibrutinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "16/12/2021", "last_updated_date": "27/06/2022", "general_url": "https://www.ema.europa.eu/en/ibrutinib-product-specific-bioequivalence-guidance" }, { "title": "Enzalutamide product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "15/12/2021", "last_updated_date": "27/06/2022", "general_url": "https://www.ema.europa.eu/en/enzalutamide-product-specific-bioequivalence-guidance" }, { "title": "VICH GL20 Efficacy of anthelmintics: specific recommendations for felines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/07/2001", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl20-efficacy-anthelmintics-specific-recommendations-felines-scientific-guideline" }, { "title": "VICH GL12 Efficacy of anthelmintics: specific recommendations for bovines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1999", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl12-efficacy-anthelmintics-specific-recommendations-bovines-scientific-guideline" }, { "title": "VICH GL21 Efficacy of anthelmintics: specific recommendations for chickens - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/07/2001", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl21-efficacy-anthelmintics-specific-recommendations-chickens-scientific-guideline" }, { "title": "VICH GL15 Efficacy of anthelmintics: specific recommendations for equines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/07/2001", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl15-efficacy-anthelmintics-specific-recommendations-equines-scientific-guideline" }, { "title": "VICH GL14 Efficacy of anthelmintics: specific requirements for caprines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1999", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl14-efficacy-anthelmintics-specific-requirements-caprines-scientific-guideline" }, { "title": "VICH GL19 Efficacy of anthelmintics: specific recommendations for canines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/07/2001", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl19-efficacy-anthelmintics-specific-recommendations-canines-scientific-guideline" }, { "title": "VICH GL13 Efficacy of anthelmintics: specific requirements for ovines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1999", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl13-efficacy-anthelmintics-specific-requirements-ovines-scientific-guideline" }, { "title": "VICH GL16 Efficacy of anthelmintics: specific requirements for porcines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/07/2001", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl16-efficacy-anthelmintics-specific-requirements-porcines-scientific-guideline" }, { "title": "VICH GL7 Efficacy of anthelmintics: general requirements - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/12/2000", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/vich-gl7-efficacy-anthelmintics-general-requirements-scientific-guideline" }, { "title": "Data requirements for veterinary medicinal products intended to reduce the risk of transmission of vector-borne pathogens in dogs and cats - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/11/2014", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/data-requirements-veterinary-medicinal-products-intended-reduce-risk-transmission-vector-borne-pathogens-dogs-cats-scientific-guideline" }, { "title": "Requirements for the production and control of immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/06/2012", "last_updated_date": "24/06/2022", "general_url": "https://www.ema.europa.eu/en/requirements-production-control-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "CAT: meeting archive 2017-2019", "summary": "", "categories": "Human", "first_published_date": "15/06/2016", "last_updated_date": "23/06/2022", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/committee-advanced-therapies-cat/cat-meeting-archive-2017-2019" }, { "title": "PDCO: meeting archive 2018-2020", "summary": "This is an archive of the meeting agendas, minutes and reports from the Paediatric Committee (PDCO) from 2018 to 2020.", "categories": "Human", "first_published_date": "14/06/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/paediatric-committee-pdco/pdco-meeting-archive-2018-2020" }, { "title": "EMA event supporting materials", "summary": "EMA has selected this series of key materials for attendees of DIA and BIO to have quick access to information about how EMA works and its recent initiatives.", "categories": "", "first_published_date": "07/02/2022", "last_updated_date": "14/06/2022", "general_url": "https://www.ema.europa.eu/en/ema-event-supporting-materials" }, { "title": "EMA supporting materials", "summary": "The European Medicines Agency (EMA) has put together key materials providing stakeholders with quick access to information about EMA's work and its recent initiatives.", "categories": "Corporate", "first_published_date": "07/02/2022", "last_updated_date": "14/06/2022", "general_url": "https://www.ema.europa.eu/en/ema-supporting-materials" }, { "title": "Submitting annual reports on medicine development", "summary": "", "categories": "Human", "first_published_date": "09/12/2011", "last_updated_date": "09/06/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/submitting-annual-reports-medicine-development" }, { "title": "Transferring an orphan designation", "summary": "", "categories": "Human", "first_published_date": "17/11/2011", "last_updated_date": "09/06/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/orphan-designation-research-and-development/transferring-orphan-designation" }, { "title": "Evaluation of anticancer medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/01/2013", "last_updated_date": "24/05/2022", "general_url": "https://www.ema.europa.eu/en/evaluation-anticancer-medicinal-products-scientific-guideline" }, { "title": "Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/04/2016", "last_updated_date": "24/05/2022", "general_url": "https://www.ema.europa.eu/en/addendum-guideline-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address-paediatric-specific-clinical-data-requirements-scientific-guideline" }, { "title": "Data requirements for multi-strain dossiers for inactivated veterinary vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/03/2010", "last_updated_date": "20/05/2022", "general_url": "https://www.ema.europa.eu/en/data-requirements-multi-strain-dossiers-inactivated-veterinary-vaccines-scientific-guideline" }, { "title": "Environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/11/2008", "last_updated_date": "20/05/2022", "general_url": "https://www.ema.europa.eu/en/environmental-impact-assessment-veterinary-medicinal-products-support-vich-guidelines-gl6-gl38-scientific-guideline" }, { "title": "External whistleblowing policy", "summary": "The European Medicines Agency (EMA) has put in place a policy for handling alledged breaches within its remit received from external persons, also known as whistleblowers. Such breaches may include allegations of non-compliance with standards of good practices that could have an impact on the evaluation and supervision of human and veterinary medicines. This policy enables EMA to protect the confidentiality of whistleblowers.", "categories": "Corporate", "first_published_date": "10/04/2017", "last_updated_date": "19/05/2022", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/external-whistleblowing-policy" }, { "title": "EMA-hosted virtual meetings", "summary": "", "categories": "Corporate", "first_published_date": "01/02/2021", "last_updated_date": "17/05/2022", "general_url": "https://www.ema.europa.eu/en/ema-hosted-virtual-meetings" }, { "title": "Specifications: test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary;Herbal", "first_published_date": "28/09/2011", "last_updated_date": "12/05/2022", "general_url": "https://www.ema.europa.eu/en/specifications-test-procedures-acceptance-criteria-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Quality of herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary;Herbal", "first_published_date": "27/01/2012", "last_updated_date": "12/05/2022", "general_url": "https://www.ema.europa.eu/en/quality-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "EMA’s governance during the COVID-19 public health emergency", "summary": "During the COVID-19 public health emergency, between 2020 and 2023, the European Medicines Agency (EMA) established dedicated task forces to deal with the scientific, regulatory and operational challenges it created, and initiated its business continuity plan.", "categories": "Human;Corporate", "first_published_date": "17/04/2020", "last_updated_date": "10/05/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/emas-governance-during-covid-19-public-health-emergency" }, { "title": "ICH Q3D Elemental impurities - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/01/2015", "last_updated_date": "03/05/2022", "general_url": "https://www.ema.europa.eu/en/ich-q3d-elemental-impurities-scientific-guideline" }, { "title": "Orphan medicines procedures", "summary": "", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "26/04/2022", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures/orphan-medicines-procedures" }, { "title": "PDCO: meeting archive 2015-2017", "summary": "This is an archive of the meeting agendas, minutes and reports from the Paediatric Committee (PDCO) from 2015 to 2017.", "categories": "Human", "first_published_date": "03/06/2016", "last_updated_date": "19/04/2022", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/paediatric-committee-pdco/pdco-meeting-archive-2015-2017" }, { "title": "Impact of the war in Ukraine on methodological aspects of ongoing clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/04/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/impact-war-ukraine-methodological-aspects-ongoing-clinical-trials-scientific-guideline" }, { "title": "ICH guidelines: Quality", "summary": "", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "01/04/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines/ich-guidelines-quality" }, { "title": "Interpretation of Article 72 of Regulation (EU) 2019/6 - Environmental safety documentation and environmental risk assessment of certain veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/10/2021", "last_updated_date": "25/03/2022", "general_url": "https://www.ema.europa.eu/en/interpretation-article-72-regulation-eu-2019-6-environmental-safety-documentation-and-environmental-risk-assessment-certain-veterinary-medicinal-products-scientific-guideline" }, { "title": "Injection-site residues - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/10/2004", "last_updated_date": "25/03/2022", "general_url": "https://www.ema.europa.eu/en/injection-site-residues-scientific-guideline" }, { "title": "Safety and residue data requirements for veterinary medicinal products intended for minor use or minor species (MUMS)/limited market - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/07/2006", "last_updated_date": "25/03/2022", "general_url": "https://www.ema.europa.eu/en/safety-residue-data-requirements-veterinary-medicinal-products-intended-minor-use-or-minor-species-mums-limited-market-scientific-guideline" }, { "title": "Determination of withdrawal periods for milk - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/03/2000", "last_updated_date": "25/03/2022", "general_url": "https://www.ema.europa.eu/en/determination-withdrawal-periods-milk-scientific-guideline" }, { "title": "Determination of withdrawal periods for edible tissue - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/04/1996", "last_updated_date": "25/03/2022", "general_url": "https://www.ema.europa.eu/en/determination-withdrawal-periods-edible-tissue-scientific-guideline" }, { "title": "ICH guideline E14/S7B: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Scientific guideline", "summary": "The ICH E14 and ICH S7B guidelines concern the multidisciplinary evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products and are complemented by a questions and answers (Q&A) document.", "categories": "Human", "first_published_date": "01/02/2016", "last_updated_date": "24/03/2022", "general_url": "https://www.ema.europa.eu/en/ich-guideline-e14-s7b-clinical-nonclinical-evaluation-qt-qtc-interval-prolongation-proarrhythmic-potential-questions-answers-scientific-guideline" }, { "title": "Submission dates (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "10/03/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/submission-dates-veterinary-medicines" }, { "title": "Application guidance (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "10/03/2022", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/application-guidance-veterinary-medicines" }, { "title": "Interpretation of Article 18(7) of Regulation (EU) 2019/6 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2021", "last_updated_date": "25/02/2022", "general_url": "https://www.ema.europa.eu/en/interpretation-article-187-regulation-eu-2019-6-scientific-guideline" }, { "title": "Criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation 2019/6", "summary": "", "categories": "Veterinary", "first_published_date": "25/02/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/criteria-determining-active-substance-essential-when-considered-context-article-372j-regulation-2019-6" }, { "title": "Patients and consumers", "summary": "The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the Agency in 1995. This cooperation was extended to include consumer groups with an interest in medicines.", "categories": "Human;Corporate", "first_published_date": "08/05/2017", "last_updated_date": "08/02/2022", "general_url": "https://www.ema.europa.eu/en/partners-networks/patients-consumers" }, { "title": "Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/08/2010", "last_updated_date": "04/02/2022", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-human-normal-immunoglobulin-intravenous-administration-ivig-scientific-guideline" }, { "title": "Core summary of product characteristics for human normal immunoglobulin for intravenous administration (IVIg) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2012", "last_updated_date": "04/02/2022", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-normal-immunoglobulin-intravenous-administration-ivig-scientific-guideline" }, { "title": "Change management for the EudraVigilance system", "summary": "The European Medicines Agency (EMA) launched an enhanced EudraVigilance system in November 2017, to support the changes to electronic reporting requirements for suspected adverse reactions brought about by the European Union (EU) pharmacovigilance legislation.", "categories": "Human", "first_published_date": "17/06/2016", "last_updated_date": "03/02/2022", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/change-management-eudravigilance-system" }, { "title": "Ethanol - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/02/2014", "last_updated_date": "31/01/2022", "general_url": "https://www.ema.europa.eu/en/ethanol-scientific-guideline" }, { "title": "Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "29/01/2021", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/guideline-data-requirements-authorisation-immunological-veterinary-medicinal-products-exceptional-circumstances-scientific-guideline" }, { "title": "Guideline on clinical trials with immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/06/2001", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/guideline-clinical-trials-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/03/2006", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/requirements-chemical-pharmaceutical-quality-documentation-concerning-investigational-medicinal-products-clinical-trials-scientific-guideline" }, { "title": "Questions and answers on requirements for pre-clinical studies submitted in support of a marketing authorisation application for a veterinary medicinal product - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/12/2021", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/questions-and-answers-requirements-pre-clinical-studies-submitted-support-marketing-authorisation-application-veterinary-medicinal-product-scientific-guideline" }, { "title": "Data requirements for vaccine antigen master files (VAMF) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "29/01/2021", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/data-requirements-vaccine-antigen-master-files-vamf-scientific-guideline" }, { "title": "Data requirements for vaccine platform technology master files (PTMF) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "28/01/2021", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/data-requirements-vaccine-platform-technology-master-files-ptmf-scientific-guideline" }, { "title": "Requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/05/2012", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/requirements-quality-documentation-concerning-biological-investigational-medicinal-products-clinical-trials-scientific-guideline" }, { "title": "Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)", "summary": "The Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv) was set up in 2005. It replaced the informal Veterinary Mutual Recognition Facilitation Group.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/coordination-group-mutual-recognition-decentralised-procedures-veterinary-medicinal-products-cmdv" }, { "title": "International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)", "summary": "The European Medicines Agency (EMA) applies relevant guidelines of the Veterinary International Conference on Harmonisation (VICH) in the field of veterinary pharmacovigilance. These guidelines are available below.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "28/01/2022", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/international-cooperation-harmonisation-technical-requirements-registration-veterinary-medicinal-products-vich" }, { "title": "Variations: guidance under Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012", "summary": "A variation is a change to the terms of a marketing authorisation. This section provides guidance for marketing authorisation holders on the regulatory requirements and procedures for the different types of variations submitted on or before 27 January 2022 to be concluded in accordance with Regulation (EC) No 1234/2008 and Regulation (EU) No 712/2012.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "20/01/2022", "general_url": "https://www.ema.europa.eu/en/variations-guidance-under-regulation-ec-no-1234-2008-regulation-eu-no-712-2012" }, { "title": "Variations for veterinary medicines", "summary": "A variation is a change to the terms of a marketing authorisation. Guidance is available from the European Medicines Agency (EMA) for marketing authorisation holders for centrally authorised veterinary medicines on the different types of variation procedure.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "20/01/2022", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-veterinary-medicines" }, { "title": "Variations not already listed (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "20/01/2022", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-veterinary-medicines/variations-not-already-listed-veterinary-medicines" }, { "title": "Transparency (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "10/01/2022", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/transparency-veterinary-medicines" }, { "title": "EudraVigilance access policy for medicines for veterinary use", "summary": "", "categories": "Veterinary", "first_published_date": "14/12/2018", "last_updated_date": "04/01/2022", "general_url": "https://www.ema.europa.eu/en/eudravigilance-access-policy-medicines-veterinary-use" }, { "title": "Open letters", "summary": "", "categories": "Corporate", "first_published_date": "15/07/2016", "last_updated_date": "22/12/2021", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/open-letters" }, { "title": "Quality documentation for medicinal products when used with a medical device - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/06/2019", "last_updated_date": "08/12/2021", "general_url": "https://www.ema.europa.eu/en/quality-documentation-medicinal-products-when-used-medical-device-scientific-guideline" }, { "title": "Applying for SME status", "summary": "Companies can apply to be registered as a micro, small and medium-sized enterprise (SME) by the European Medicines Agency (EMA) if they meet the definition of an SME (SME criteria). This enables them to benefit from fee incentives and other support from EMA.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "07/12/2021", "general_url": "https://www.ema.europa.eu/en/about-us/support-smes/applying-sme-status" }, { "title": "Classifications as minor-use-minor-species and limited-market according to former EMA policy", "summary": "", "categories": "Veterinary", "first_published_date": "15/07/2011", "last_updated_date": "06/12/2021", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/veterinary-limited-markets/former-ema-policy-minor-use-minor-species-mums-limited-markets/classifications-minor-use-minor-species-limited-market-according-former-ema-policy" }, { "title": "EudraGMDP database", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "01/12/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/eudragmdp-database" }, { "title": "Guideline on registry-based studies - Scientific guideline", "summary": "This guideline addresses the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making.", "categories": "Human", "first_published_date": "26/10/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/guideline-registry-based-studies-scientific-guideline" }, { "title": "Data submission on investigational medicines: guidance for clinical trial sponsors", "summary": "Researchers and companies wishing to carry out a clinical trial for medicines for human use in the European Union (EU) and European Economic Area (EEA), need to submit information on the investigational medicine involved to the European Medicines Agency (EMA).", "categories": "Human", "first_published_date": "21/10/2021", "last_updated_date": "21/10/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/clinical-trials-human-medicines/data-submission-investigational-medicines-guidance-clinical-trial-sponsors" }, { "title": "Scientific guidelines for limited market products deemed not eligible for authorisation under Article 23 of Regulation 2019/6", "summary": "", "categories": "Veterinary", "first_published_date": "15/10/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/scientific-guidelines-limited-market-products-deemed-not-eligible-authorisation-under-article-23-regulation-2019-6" }, { "title": "Dasatinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/07/2015", "last_updated_date": "07/10/2021", "general_url": "https://www.ema.europa.eu/en/dasatinib-product-specific-bioequivalence-guidance" }, { "title": "Use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) - Scientific guideline", "summary": "", "categories": "Herbal", "first_published_date": "22/12/2014", "last_updated_date": "01/10/2021", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas-scientific-guideline" }, { "title": "Lapatinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/06/2018", "last_updated_date": "22/09/2021", "general_url": "https://www.ema.europa.eu/en/lapatinib-product-specific-bioequivalence-guidance" }, { "title": "Palbociclib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "08/02/2019", "last_updated_date": "22/09/2021", "general_url": "https://www.ema.europa.eu/en/palbociclib-product-specific-bioequivalence-guidance" }, { "title": "Methods found suitable within the European Union for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/07/2015", "last_updated_date": "17/09/2021", "general_url": "https://www.ema.europa.eu/en/methods-found-suitable-within-european-union-demonstrating-freedom-extraneous-agents-seeds-used-production-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Higher tier testing to investigate the effects of parasiticidal veterinary medicinal products on dung fauna - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/higher-tier-testing-investigate-effects-parasiticidal-veterinary-medicinal-products-dung-fauna-scientific-guideline" }, { "title": "Statistical methodology for the comparative assessment of quality attributes in drug development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/06/2013", "last_updated_date": "27/07/2021", "general_url": "https://www.ema.europa.eu/en/statistical-methodology-comparative-assessment-quality-attributes-drug-development-scientific-guideline" }, { "title": "Fixed combination products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/12/2006", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/fixed-combination-products-scientific-guideline" }, { "title": "COVID-19 guidance: evaluation and marketing authorisation", "summary": "During the COVID-19 public health emergency, the European Medicines Agency (EMA) assessed applications for COVID-19 medicines under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. ", "categories": "Human", "first_published_date": "15/12/2020", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/guidance-medicine-developers-other-stakeholders-covid-19/covid-19-guidance-evaluation-marketing-authorisation" }, { "title": "Specific efficacy requirements for ectoparasiticides in cattle - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/07/2004", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/specific-efficacy-requirements-ectoparasiticides-cattle-scientific-guideline" }, { "title": "Specific efficacy requirements for ectoparasiticides in sheep - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/07/2002", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/specific-efficacy-requirements-ectoparasiticides-sheep-scientific-guideline" }, { "title": "Demonstration of palatability of veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/07/2014", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/demonstration-palatability-veterinary-medicinal-products-scientific-guideline" }, { "title": "Demonstration of target animal safety and efficacy of veterinary medicinal products intended for use in farmed finfish - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/05/2011", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/demonstration-target-animal-safety-efficacy-veterinary-medicinal-products-intended-use-farmed-finfish-scientific-guideline" }, { "title": "Promoting the authorisation of alternatives to antimicrobial veterinary medicinal products in the EU - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/10/2019", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/promoting-authorisation-alternatives-antimicrobial-veterinary-medicinal-products-eu-scientific-guideline" }, { "title": "Statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/01/2012", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/statistical-principles-clinical-trials-veterinary-medicinal-products-pharmaceuticals-scientific-guideline" }, { "title": "Conduct of efficacy studies for non-steroidal anti-inflammatory drugs (NSAIDs) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/01/2014", "last_updated_date": "26/07/2021", "general_url": "https://www.ema.europa.eu/en/conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs-nsaids-scientific-guideline" }, { "title": "Manufacture of the finished dosage form (veterinary) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/12/1995", "last_updated_date": "23/07/2021", "general_url": "https://www.ema.europa.eu/en/manufacture-finished-dosage-form-veterinary-scientific-guideline" }, { "title": "Environmental risk assessment of veterinary medicinal products intended to be used in aquaculture - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/07/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-veterinary-medicinal-products-intended-be-used-aquaculture-scientific-guideline" }, { "title": "Data requirements for adjuvants in vaccines for veterinary use - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/11/1996", "last_updated_date": "23/07/2021", "general_url": "https://www.ema.europa.eu/en/data-requirements-adjuvants-vaccines-veterinary-use-scientific-guideline" }, { "title": "Validity of a marketing authorisation (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "13/07/2021", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/validity-marketing-authorisation-veterinary-medicines" }, { "title": "Executive Director", "summary": "The European Medicines Agency's (EMA) Executive Director is Ms Emer Cooke.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "09/07/2021", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/executive-director" }, { "title": "COVID-19 guidance: post-authorisation", "summary": "Duing the COVID-19 public health emergency, the European medicines Agency (EMA) mobilised extra resources to monitor safety and manage risk, particularly with COVID-19 vaccines. EMA provided guidance on pharmacovigilance, risk management and other topics.", "categories": "Human", "first_published_date": "15/12/2020", "last_updated_date": "09/07/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/guidance-medicine-developers-other-stakeholders-covid-19/covid-19-guidance-post-authorisation" }, { "title": "Procurement activities 2020", "summary": "", "categories": "Corporate", "first_published_date": "12/10/2020", "last_updated_date": "30/06/2021", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2020" }, { "title": "Concept paper for the revision of residues guidelines to align with the definitions for withdrawal periods provided in Regulation (EU) 2019/6 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/06/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-revision-residues-guidelines-align-definitions-withdrawal-periods-provided-regulation-eu-2019-6-scientific-guideline" }, { "title": "Medicines for human use under evaluation 2020–2018", "summary": "", "categories": "Human", "first_published_date": "02/06/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation/medicines-human-use-under-evaluation-2020-2018" }, { "title": "Medicines for human use under evaluation 2017–2015", "summary": "", "categories": "Human", "first_published_date": "02/06/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation/medicines-human-use-under-evaluation-2017-2015" }, { "title": "Medicines for human use under evaluation 2014–2012", "summary": "", "categories": "Human", "first_published_date": "02/06/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation/medicines-human-use-under-evaluation-2014-2012" }, { "title": "ICH S1 Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/2012", "last_updated_date": "20/05/2021", "general_url": "https://www.ema.europa.eu/en/ich-s1-regulatory-notice-changes-core-guideline-rodent-carcinogenicity-testing-pharmaceuticals-scientific-guideline" }, { "title": "COVID-19 vaccines: development, evaluation, approval and monitoring", "summary": "The European Medicines Agency (EMA) plays an important role in enabling the development, scientific evaluation, approval and monitoring of COVID-19 vaccines in the European Union (EU). ", "categories": "Human", "first_published_date": "05/11/2020", "last_updated_date": "18/05/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-development-evaluation-approval-monitoring" }, { "title": "Brazil", "summary": "The European Commission, European Medicines Agency (EMA) and the Brazilian Health Regulatory Agency (ANVISA) have a confidentiality arrangement in place since 2021, allowing the exchange of confidential information as part of their regulatory and scientific processes.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "06/05/2021", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/brazil" }, { "title": "Monitoring of COVID-19 medicines", "summary": "The European Medicines Agency (EMA) makes use of real-world data to monitor the safety and effectiveness of authorised COVID-19 treatments and vaccines and other medicines used in patients with COVID-19 in the European Union (EU).", "categories": "Human", "first_published_date": "17/04/2020", "last_updated_date": "26/04/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergency-international-concern-2020-23/monitoring-covid-19-medicines" }, { "title": "Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/07/2008", "last_updated_date": "22/04/2021", "general_url": "https://www.ema.europa.eu/en/toolbox-guidance-scientific-elements-and-regulatory-tools-support-quality-data-packages-prime-and-certain-marketing-authorisation-applications-targeting-unmet-medical-need-scientific-guideline" }, { "title": "Compliance: Overview", "summary": "All organisations involved in the development, marketing, manufacture and distribution of medicines are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals. The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify compliance.", "categories": "Human;Veterinary", "first_published_date": "31/03/2017", "last_updated_date": "09/04/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/compliance-overview" }, { "title": "Authenticity verification for electronic certificates", "summary": "Health authorities outside the European Union (EU) and any interested party can verify the authenticity of an electronic certificate issued by the European Medicines Agency (EMA). The certificate confirms the marketing authorisation status of a medicine and compliance of manufacturing sites with good manufacturing practice (GMP).", "categories": "Human;Veterinary", "first_published_date": "06/04/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/certification-medicinal-products/authenticity-verification-electronic-certificates" }, { "title": "Biologics Working Party documents", "summary": "This page lists the documents published by the European Medicines Agency's Biologics Working Party.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "30/03/2021", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/biologics-working-party/biologics-working-party-documents" }, { "title": "Consultation procedure for ancillary medicinal substances in medical devices", "summary": "Regulation EU 2017/745 requires notified bodies to seek an opinion from a competent authority on the quality and safety of medicinal substances incorporated in medical devices that have an action that is ancillary (i.e supports) to the action of the device.", "categories": "Human", "first_published_date": "15/03/2016", "last_updated_date": "30/03/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices" }, { "title": "ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2004", "last_updated_date": "19/03/2021", "general_url": "https://www.ema.europa.eu/en/ich-m4-common-technical-document-ctd-registration-pharmaceuticals-human-use-organisation-ctd-scientific-guideline" }, { "title": "Brexit: the United Kingdom's withdrawal from the European Union", "summary": "The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. During a transition period from 1 February to 31 December 2020, EU pharmaceutical law continued to apply to the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only.", "categories": "Corporate", "first_published_date": "06/07/2016", "last_updated_date": "09/03/2021", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/brexit-united-kingdoms-withdrawal-european-union" }, { "title": "Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/11/2018", "last_updated_date": "01/03/2021", "general_url": "https://www.ema.europa.eu/en/antimicrobial-resistance-environment-considerations-current-and-future-risk-assessment-veterinary-medicinal-products-scientific-guideline" }, { "title": "Use of aminopenicillins and their beta-lactamase inhibitor combinations in animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/09/2018", "last_updated_date": "01/03/2021", "general_url": "https://www.ema.europa.eu/en/use-aminopenicillins-their-beta-lactamase-inhibitor-combinations-animals-european-union-development-resistance-impact-human-animal-health-scientific-guideline" }, { "title": "Quality and safety assessment for the plasma master file (PMF) certification with regard to donor deferral criteria for sexual risk behaviour - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/02/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/quality-and-safety-assessment-plasma-master-file-pmf-certification-regard-donor-deferral-criteria-sexual-risk-behaviour-scientific-guideline" }, { "title": "Regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/02/2021", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/regulatory-requirements-vaccines-intended-provide-protection-against-variant-strains-sars-cov-2-scientific-guideline" }, { "title": "Linguistic review - Veterinary", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "08/02/2021", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/product-information-requirements-veterinary-medicines/linguistic-review-veterinary" }, { "title": "Sorafenib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/07/2015", "last_updated_date": "05/02/2021", "general_url": "https://www.ema.europa.eu/en/sorafenib-product-specific-bioequivalence-guidance" }, { "title": "CVMP strategy on antimicrobials 2021-2025", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "02/02/2021", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/cvmp-strategy-antimicrobials-2021-2025" }, { "title": "Quality of water for pharmaceutical use - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/05/2002", "last_updated_date": "01/02/2021", "general_url": "https://www.ema.europa.eu/en/quality-water-pharmaceutical-use-scientific-guideline" }, { "title": "Data Monitoring Committees issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/08/2018", "last_updated_date": "29/01/2021", "general_url": "https://www.ema.europa.eu/en/data-monitoring-committees-issues-scientific-guideline" }, { "title": "Immunologicals: guidelines - General", "summary": "The European Medicines Agency's scientific guidelines on immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "28/01/2021", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/immunological-guidelines/immunologicals-guidelines-general" }, { "title": "Coronavirus disease (COVID-19)", "summary": "The European Medicines Agency (EMA) contributes to global efforts to protect people from COVID-19. EMA enables the development and approval of safe and effective treatments and vaccines and provides reliable information to patients and healthcare professionals in the European Union (EU).", "categories": "Human", "first_published_date": "04/02/2020", "last_updated_date": "14/01/2021", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19" }, { "title": "Dose review and adjustment of established veterinary antibiotics in the context summary of product characteristic (SPC) harmonisation - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "27/07/2018", "last_updated_date": "13/01/2021", "general_url": "https://www.ema.europa.eu/en/dose-review-adjustment-established-veterinary-antibiotics-context-summary-product-characteristic-spc-harmonisation-scientific-guideline" }, { "title": "Product information: Reference documents and guidelines", "summary": "This page lists the reference documents and guidelines on the quality of product information for centrally authorised human medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/product-information-reference-documents-guidelines-0" }, { "title": "Conditional marketing authorisation", "summary": "The European Medicines Agency (EMA) supports the development of medicines that address unmet medical needs. In the interest of public health, applicants may be granted a conditional marketing authorisation for such medicines on less comprehensive clinical data than normally required, where the benefit of immediate availability of the medicine outweighs the risk inherent in the fact that additional data are still required.", "categories": "Human", "first_published_date": "15/02/2016", "last_updated_date": "21/12/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/conditional-marketing-authorisation" }, { "title": "Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/05/2012", "last_updated_date": "17/12/2020", "general_url": "https://www.ema.europa.eu/en/quality-non-clinical-clinical-aspects-medicinal-products-containing-genetically-modified-cells-scientific-guideline" }, { "title": "Enpr-EMA governance and meetings", "summary": "The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is governed by a coordinating group which sets the network's long- and short-term strategy. It also sets up ad-hoc working groups to work on priority tasks set by the coordinating group following Enpr-EMA's annual workshops.", "categories": "Human;Corporate", "first_published_date": "25/07/2019", "last_updated_date": "16/12/2020", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema/enpr-ema-governance-meetings" }, { "title": "Excipients labelling", "summary": "Marketing authorisation holders and applicants need to identify the excipients included in any human medicine authorised in the European Union (EU) in its product information. Guidance is available from the European Commission and European Medicines Agency (EMA) on what needs including in the labelling and package leaflet.", "categories": "Human", "first_published_date": "30/06/2016", "last_updated_date": "11/12/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/excipients-labelling" }, { "title": "ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs - Scientific guideline", "summary": "This guideline provides recommendations on the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. Read together with questions and answers.", "categories": "Human", "first_published_date": "01/11/2005", "last_updated_date": "08/12/2020", "general_url": "https://www.ema.europa.eu/en/ich-e14-clinical-evaluation-qt-qtc-interval-prolongation-proarrhythmic-potential-non-antiarrhythmic-drugs-scientific-guideline" }, { "title": "Abiraterone acetate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/08/2016", "last_updated_date": "23/11/2020", "general_url": "https://www.ema.europa.eu/en/abiraterone-acetate-product-specific-bioequivalence-guidance" }, { "title": "Multidisciplinary guidelines: vaccines", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "19/11/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-vaccines" }, { "title": "EMA considerations on COVID-19 vaccine approval - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/ema-considerations-covid-19-vaccine-approval-scientific-guideline" }, { "title": "Compassionate use", "summary": "Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "26/10/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compassionate-use" }, { "title": "Pharmaceutical development of medicines for use in the older population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "05/04/2013", "last_updated_date": "22/10/2020", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-development-medicines-use-older-population-scientific-guideline" }, { "title": "Guideline on registry-based studies", "summary": "", "categories": "Human", "first_published_date": "24/09/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/guideline-registry-based-studies" }, { "title": "Paediatric Regulation", "summary": "The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "28/08/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overview/paediatric-regulation" }, { "title": "Stem cell-based products for veterinary use: Specific question on target animal safety addressed by CVMP/ADVENT - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/07/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-question-target-animal-safety-addressed-cvmp-advent-scientific-guideline" }, { "title": "Pharmacovigilance training materials", "summary": "", "categories": "Human", "first_published_date": "01/07/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/pharmacovigilance-overview/pharmacovigilance-training-materials" }, { "title": "Reporting of physiologically based pharmacokinetic (PBPK) modelling and simulation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/2016", "last_updated_date": "01/07/2020", "general_url": "https://www.ema.europa.eu/en/reporting-physiologically-based-pharmacokinetic-pbpk-modelling-simulation-scientific-guideline" }, { "title": "Procurement activities 2019", "summary": "", "categories": "Corporate", "first_published_date": "05/02/2019", "last_updated_date": "30/06/2020", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2019" }, { "title": "Implications of coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/03/2020", "last_updated_date": "29/06/2020", "general_url": "https://www.ema.europa.eu/en/implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials-scientific-guideline" }, { "title": "Questions and answers on management of extraneous agents in immunological veterinary medicinal products (IVMPs) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/06/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/questions-answers-management-extraneous-agents-immunological-veterinary-medicinal-products-ivmps-scientific-guideline" }, { "title": "Canada", "summary": "The European Commission, the European Medicines Agency (EMA) and Health Canada have had confidentiality arrangements in place since 2007, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European union (EU) and Canada also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "16/06/2020", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/canada" }, { "title": "Environmental risk assessment of veterinary medicines", "summary": "", "categories": "Veterinary", "first_published_date": "02/06/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/environmental-risk-assessment-veterinary-medicines" }, { "title": "Environmental risk assessment for parasiticide veterinary medicinal products used in companion animals - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/05/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-parasiticide-veterinary-medicinal-products-used-companion-animals-scientific-guideline" }, { "title": "COVID-19: information on veterinary medicines", "summary": "The European Medicines Agency (EMA) and its partners in the European medicines regulatory network have monitored the potential impact of the COVID-19 pandemic on the veterinary medicine supply chain in the European Union (EU).", "categories": "Veterinary", "first_published_date": "04/05/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/covid-19-information-veterinary-medicines" }, { "title": "Procedure on management of proposals from interested parties for Community list entries or Community herbal monographs", "summary": "", "categories": "Herbal", "first_published_date": "11/03/2016", "last_updated_date": "15/04/2020", "general_url": "https://www.ema.europa.eu/en/procedure-management-proposals-interested-parties-community-list-entries-or-community-herbal-monographs" }, { "title": "Etonogestrel and ethinylestradiol vaginal delivery system product-specific bioequivalence", "summary": "", "categories": "Human", "first_published_date": "27/05/2019", "last_updated_date": "01/04/2020", "general_url": "https://www.ema.europa.eu/en/etonogestrel-and-ethinylestradiol-vaginal-delivery-system-product-specific-bioequivalence" }, { "title": "EudraVigilance", "summary": "EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.", "categories": "Human", "first_published_date": "17/06/2016", "last_updated_date": "25/03/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance" }, { "title": "ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2017", "last_updated_date": "04/03/2020", "general_url": "https://www.ema.europa.eu/en/ich-q12-technical-regulatory-considerations-pharmaceutical-product-lifecycle-management-scientific-guideline" }, { "title": "CHMP: meeting archive 2016-2018", "summary": "This is an archive of the meeting highlights, agendas and minutes from the Committee for Medicinal Products for Human Use (CHMP) in 2016 to 2018.", "categories": "Human", "first_published_date": "26/02/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/committee-medicinal-products-human-use-chmp/chmp-meeting-archive-2016-2018" }, { "title": "ICH E9 statistical principles for clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/09/1998", "last_updated_date": "18/02/2020", "general_url": "https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials-scientific-guideline" }, { "title": "Direct healthcare professional communications (DHPC)", "summary": "A marketing authorisation holder may send a direct healthcare professional communication (DHPC) to healthcare professionals to inform them of important new safety information about a medicine and any actions they should take. The European Medicines Agency (EMA) publishes direct healthcare professional communications on this website.  ", "categories": "Human", "first_published_date": "14/02/2020", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/direct-healthcare-professional-communications-dhpc" }, { "title": "ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/08/2018", "last_updated_date": "11/02/2020", "general_url": "https://www.ema.europa.eu/en/ich-m9-biopharmaceutics-classification-system-based-biowaivers-scientific-guideline" }, { "title": "Rewards and incentives for paediatric medicines", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "11/02/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/rewards-incentives-paediatric-medicines" }, { "title": "Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2015", "last_updated_date": "31/01/2020", "general_url": "https://www.ema.europa.eu/en/assessment-persistent-bioaccumulative-toxic-pbt-or-very-persistent-very-bioaccumulative-vpvb-substances-veterinary-medicinal-products-scientific-guideline" }, { "title": "Electronic product information for human medicines in the European Union – key principles", "summary": "", "categories": "Human", "first_published_date": "31/01/2019", "last_updated_date": "29/01/2020", "general_url": "https://www.ema.europa.eu/en/electronic-product-information-human-medicines-european-union-key-principles" }, { "title": "Activities after orphan designation", "summary": "", "categories": "Human", "first_published_date": "18/12/2012", "last_updated_date": "16/01/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/orphan-designation-research-and-development/activities-after-orphan-designation" }, { "title": "Orphan incentives", "summary": "", "categories": "Human", "first_published_date": "30/03/2010", "last_updated_date": "16/01/2020", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/orphan-incentives" }, { "title": "Q&A: Worksharing of variations", "summary": "", "categories": "Veterinary", "first_published_date": "16/12/2010", "last_updated_date": "20/12/2019", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/worksharing-variations-veterinary-medicines/qa-worksharing-variations" }, { "title": "Alectinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "08/02/2019", "last_updated_date": "19/12/2019", "general_url": "https://www.ema.europa.eu/en/alectinib-product-specific-bioequivalence-guidance" }, { "title": "VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "27/07/2018", "last_updated_date": "17/12/2019", "general_url": "https://www.ema.europa.eu/en/vich-gl58-stability-testing-new-veterinary-drug-substances-medicinal-products-climatic-zones-iii-iv-scientific-guideline" }, { "title": "Questions and answers on comparability considerations for advanced therapy medicinal products (ATMP) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/questions-and-answers-comparability-considerations-advanced-therapy-medicinal-products-atmp-scientific-guideline" }, { "title": "Authorisation of medicines", "summary": "All medicines must be authorised before they can be marketed and made available to patients. In the European Union (EU), there are two main routes for authorising medicines: a centralised route and a national route.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "05/12/2019", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines" }, { "title": "Concept paper for the revision of scientific guidelines on limited market for veterinary medicinal products", "summary": "", "categories": "Veterinary", "first_published_date": "21/11/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-revision-scientific-guidelines-limited-market-veterinary-medicinal-products" }, { "title": "Medicines under additional monitoring", "summary": "", "categories": "Human", "first_published_date": "25/04/2013", "last_updated_date": "21/11/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring" }, { "title": "Relocation to Amsterdam", "summary": "On 20 November 2017, European Union (EU) Member States decided to relocate the European Medicines Agency (EMA) to Amsterdam, the Netherlands, as a result of the United Kingdom's (UK) withdrawal from the EU. The Agency immediately began working with the Dutch authorities to prepare for the move and take up its operations in Amsterdam by 30 March 2019.", "categories": "Corporate", "first_published_date": "15/12/2017", "last_updated_date": "15/11/2019", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/relocation-amsterdam" }, { "title": "Clinical investigation of medicinal products for the treatment of gout - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/06/2012", "last_updated_date": "14/11/2019", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-gout-scientific-guideline" }, { "title": "Pharmacokinetic and clinical evaluation of modified-release dosage forms - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/11/2014", "last_updated_date": "29/10/2019", "general_url": "https://www.ema.europa.eu/en/pharmacokinetic-clinical-evaluation-modified-release-dosage-forms-scientific-guideline" }, { "title": "Gefitinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/06/2018", "last_updated_date": "15/10/2019", "general_url": "https://www.ema.europa.eu/en/gefitinib-product-specific-bioequivalence-guidance" }, { "title": "Ezetimibe product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/12/2018", "last_updated_date": "15/10/2019", "general_url": "https://www.ema.europa.eu/en/ezetimibe-product-specific-bioequivalence-guidance" }, { "title": "Cabozantinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "17/12/2018", "last_updated_date": "15/10/2019", "general_url": "https://www.ema.europa.eu/en/cabozantinib-product-specific-bioequivalence-guidance" }, { "title": "Training opportunities for non-EU regulators", "summary": "", "categories": "Human;Veterinary;Corporate", "first_published_date": "03/10/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/training-opportunities-non-eu-regulators" }, { "title": "Enpr-EMA meeting documents archive", "summary": "", "categories": "", "first_published_date": "25/07/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks/european-network-paediatric-research-european-medicines-agency-enpr-ema/enpr-ema-governance-and-meetings/enpr-ema-meeting-documents-archive" }, { "title": "Investigation of medicinal products in the term and preterm neonate - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/06/2009", "last_updated_date": "01/07/2019", "general_url": "https://www.ema.europa.eu/en/investigation-medicinal-products-term-preterm-neonate-scientific-guideline" }, { "title": "Stem cell-based products for veterinary use: Specific questions on extraneous agents to be addressed by Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "27/06/2016", "last_updated_date": "28/06/2019", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-questions-extraneous-agents-be-addressed-ad-hoc" }, { "title": "Procurement activities 2018", "summary": "", "categories": "Corporate", "first_published_date": "16/02/2018", "last_updated_date": "28/06/2019", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2018" }, { "title": "Stem cell-based products for veterinary use: specific questions on sterility to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/02/2016", "last_updated_date": "28/06/2019", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-questions-sterility-be-addressed-ad-hoc-expert" }, { "title": "The evaluation of medicines, step-by-step", "summary": "The assessment of a marketing authorisation application for a new medicine takes up to 210 ‘active’ days. This active evaluation time is the time spent by EMA experts to evaluate the evidence provided by the applicant in support of a marketing authorisation application.", "categories": "Human", "first_published_date": "27/06/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/evaluation-medicines-step-step" }, { "title": "Support for advanced-therapy developers", "summary": "", "categories": "Human", "first_published_date": "04/05/2015", "last_updated_date": "25/06/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/support-advanced-therapy-developers" }, { "title": "Q&A: Type II variations vs Extension applications", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "18/06/2019", "general_url": "https://www.ema.europa.eu/en/qa-type-ii-variations-vs-extension-applications" }, { "title": "Parallel distribution", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "02/05/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/parallel-distribution" }, { "title": "European Directorate for the Quality of Medicines and HealthCare (EDQM) of the Council of Europe", "summary": "", "categories": "", "first_published_date": "20/01/2014", "last_updated_date": "09/04/2019", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/european-directorate-quality-medicines-healthcare-edqm-council-europe" }, { "title": "VICH GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/07/2012", "last_updated_date": "03/04/2019", "general_url": "https://www.ema.europa.eu/en/vich-gl36-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-microbiological-adi-scientific-guideline" }, { "title": "VICH GL57 on studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: marker residue depletion studies to establish product withdrawal periods in aquatic species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/01/2018", "last_updated_date": "03/04/2019", "general_url": "https://www.ema.europa.eu/en/vich-gl57-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-species-marker-residue-depletion-studies-establish-product-withdrawal-periods-aquatic-species-scientific" }, { "title": "Investigation of subgroups in confirmatory clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/02/2014", "last_updated_date": "14/03/2019", "general_url": "https://www.ema.europa.eu/en/investigation-subgroups-confirmatory-clinical-trials-scientific-guideline" }, { "title": "Sterilisation of the medicinal product, active substance, excipient and primary container - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/04/2016", "last_updated_date": "08/03/2019", "general_url": "https://www.ema.europa.eu/en/sterilisation-medicinal-product-active-substance-excipient-primary-container-scientific-guideline" }, { "title": "EMA in London (1995-2019)", "summary": "", "categories": "Corporate", "first_published_date": "01/03/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/ema-london-1995-2019" }, { "title": "Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry", "summary": "", "categories": "Human", "first_published_date": "28/02/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/cellular-therapy-module-european-society-blood-marrow-transplantation-ebmt-registry" }, { "title": "Veterinary pharmacovigilance inspections: Q&As", "summary": "The European Medicines Agency (EMA) and the Pharmacovigilance Inspectors Working Group provides guidance on veterinary pharmacovigilance obligations in the form of questions and answers (Q&As).", "categories": "Veterinary", "first_published_date": "28/02/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation/veterinary-pharmacovigilance-inspections-qas" }, { "title": "Adjustment for cross-over in estimating effects in oncology trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/adjustment-cross-over-estimating-effects-oncology-trials-scientific-guideline" }, { "title": "Public statement on the use of herbal medicinal products containing toxic, unsaturated pyrrolizidine alkaloids (PAs) including recommendations regarding contamination of herbal medicinal products with PAs", "summary": "", "categories": "Human;Herbal", "first_published_date": "09/06/2016", "last_updated_date": "28/02/2019", "general_url": "https://www.ema.europa.eu/en/public-statement-use-herbal-medicinal-products-containing-toxic-unsaturated-pyrrolizidine-alkaloids-pas-including-recommendations-regarding-contamination-herbal-medicinal-products-pas" }, { "title": "Template for information exchange for the preparation of the assessment report supporting the establishment of European Union monographs and European Union list entries", "summary": "", "categories": "Herbal", "first_published_date": "16/03/2016", "last_updated_date": "25/02/2019", "general_url": "https://www.ema.europa.eu/en/template-information-exchange-preparation-assessment-report-supporting-establishment-european-union-monographs-european-union-list-entries" }, { "title": "Non-clinical documentation in applications for marketing authorisation / registration of well-established and traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Herbal", "first_published_date": "07/09/2006", "last_updated_date": "25/02/2019", "general_url": "https://www.ema.europa.eu/en/non-clinical-documentation-applications-marketing-authorisation-registration-well-established-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Post-authorisation", "summary": "The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle. The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.", "categories": "Human", "first_published_date": "01/12/2016", "last_updated_date": "08/02/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation" }, { "title": "Reporting a falsified product to EMA", "summary": "", "categories": "Human", "first_published_date": "08/02/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/falsified-medicines-reporting-obligations/reporting-falsified-product-ema" }, { "title": "Falsified medicines: reporting obligations", "summary": "", "categories": "Human", "first_published_date": "08/02/2019", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/falsified-medicines-reporting-obligations" }, { "title": "Octreotide acetate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/06/2018", "last_updated_date": "08/02/2019", "general_url": "https://www.ema.europa.eu/en/octreotide-acetate-product-specific-bioequivalence-guidance" }, { "title": "Questions and answers: Urgent Union procedures (Article 107i)", "summary": "", "categories": "Human", "first_published_date": "19/12/2012", "last_updated_date": "05/02/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-urgent-union-procedures-article-107i" }, { "title": "Questions and answers: Article 31 pharmacovigilance referrals", "summary": "", "categories": "Human", "first_published_date": "22/01/2014", "last_updated_date": "04/02/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-31-pharmacovigilance-referrals" }, { "title": "Questions and answers: Article 20 pharmacovigilance procedures", "summary": "This page lists questions that stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 20 procedure resulting from the evaluation of data from pharmacovigilance activities.", "categories": "Human", "first_published_date": "28/04/2015", "last_updated_date": "04/02/2019", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-20-pharmacovigilance-procedures" }, { "title": "Antimicrobial Advice Ad Hoc Expert Group", "summary": "", "categories": "Human;Veterinary", "first_published_date": "17/07/2018", "last_updated_date": "01/02/2019", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/working-parties-and-other-groups/cvmp-working-parties-and-other-groups/antimicrobial-advice-ad-hoc-expert-group" }, { "title": "Assessment and control of DNA reactive (mutagenic) impurities in veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/02/2017", "last_updated_date": "09/01/2019", "general_url": "https://www.ema.europa.eu/en/assessment-control-dna-reactive-mutagenic-impurities-veterinary-medicinal-products-scientific-guideline" }, { "title": "Concept paper on a guideline for allergen products development in moderate to low-sized study populations - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/12/2018", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/concept-paper-guideline-allergen-products-development-moderate-low-sized-study-populations-scientific-guideline" }, { "title": "Clinical development of fixed combination medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/02/2009", "last_updated_date": "17/12/2018", "general_url": "https://www.ema.europa.eu/en/clinical-development-fixed-combination-medicinal-products-scientific-guideline" }, { "title": "Access to documents", "summary": "In accordance with European Union (EU) law, the European Medicines Agency (EMA) is committed to ensuring the widest possible access to its documents following requests from the public. It is also committed to increasing its level of openness and transparency over its decision-making processes. ", "categories": "Corporate", "first_published_date": "06/10/2010", "last_updated_date": "23/11/2018", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/access-documents" }, { "title": "Non-clinical requirements for radiopharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/08/2017", "last_updated_date": "22/11/2018", "general_url": "https://www.ema.europa.eu/en/non-clinical-requirements-radiopharmaceuticals-scientific-guideline" }, { "title": "Off-label use of antimicrobials in veterinary medicine in the European Union - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/07/2017", "last_updated_date": "21/11/2018", "general_url": "https://www.ema.europa.eu/en/label-use-antimicrobials-veterinary-medicine-european-union-scientific-guideline" }, { "title": "Sodium laurilsulfate - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/08/2015", "last_updated_date": "19/11/2018", "general_url": "https://www.ema.europa.eu/en/sodium-laurilsulfate-scientific-guideline" }, { "title": "Aspartame and phenylalanine - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/05/2016", "last_updated_date": "19/11/2018", "general_url": "https://www.ema.europa.eu/en/aspartame-phenylalanine-scientific-guideline" }, { "title": "Polysorbates - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2018", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/polysorbates-scientific-guideline" }, { "title": "Lactose - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2018", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/lactose-scientific-guideline" }, { "title": "CVMP: meeting archive 2016-2018", "summary": "This is an archive of the meeting highlights and monthly reports from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) in 2016 to 2018.", "categories": "Veterinary", "first_published_date": "17/12/2009", "last_updated_date": "09/11/2018", "general_url": "https://www.ema.europa.eu/en/committees-working-parties-and-other-groups/committee-veterinary-medicinal-products-cvmp/cvmp-meeting-archive-2016-2018" }, { "title": "Questions and answers on bovine spongiform encephalopathies (BSE) and vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/04/2001", "last_updated_date": "08/11/2018", "general_url": "https://www.ema.europa.eu/en/questions-answers-bovine-spongiform-encephalopathies-bse-vaccines-scientific-guideline" }, { "title": "Questions and answers on the Haemagglutination Inhibition (HI) test for qualification of influenza vaccine (inactivated) seed preparations - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2018", "last_updated_date": "08/11/2018", "general_url": "https://www.ema.europa.eu/en/questions-answers-haemagglutination-inhibition-hi-test-qualification-influenza-vaccine-inactivated-seed-preparations-scientific-guideline" }, { "title": "Quality aspects included in the product information for vaccines for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/11/2003", "last_updated_date": "07/11/2018", "general_url": "https://www.ema.europa.eu/en/quality-aspects-included-product-information-vaccines-human-use-scientific-guideline" }, { "title": "Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/1995", "last_updated_date": "07/11/2018", "general_url": "https://www.ema.europa.eu/en/equivalence-studies-demonstration-therapeutic-equivalence-locally-applied-locally-acting-products-gastrointestinal-tract-scientific-guideline" }, { "title": "Treatment and prophylaxis of respiratory syncytial virus (RSV) disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/10/2016", "last_updated_date": "07/11/2018", "general_url": "https://www.ema.europa.eu/en/treatment-prophylaxis-respiratory-syncytial-virus-rsv-disease-scientific-guideline" }, { "title": "Extrapolation of efficacy and safety in paediatric medicine development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/04/2016", "last_updated_date": "30/10/2018", "general_url": "https://www.ema.europa.eu/en/extrapolation-efficacy-safety-paediatric-medicine-development-scientific-guideline" }, { "title": "ICH guidelines: safety", "summary": "", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "27/09/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines/ich-guidelines-safety" }, { "title": "Remote connection to EMA IT Systems", "summary": "The European Medicines Agency (EMA) provides instructions to staff members unable to connect to its networks while teleworking.", "categories": "", "first_published_date": "24/09/2018", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/remote-connection-ema-it-systems" }, { "title": "Reflection paper on resistance in ectoparasites - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/09/2018", "last_updated_date": "21/09/2018", "general_url": "https://www.ema.europa.eu/en/reflection-paper-resistance-ectoparasites-scientific-guideline" }, { "title": "Questions and answers: Article 31 non-pharmacovigilance referrals", "summary": "", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "21/09/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-31-non-pharmacovigilance-referrals" }, { "title": "RSS feeds", "summary": "", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "20/09/2018", "general_url": "https://www.ema.europa.eu/en/rss-feeds" }, { "title": "The adequacy of the Mahalanobis distance to assess the comparability of drug dissolution profiles - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/09/2018", "last_updated_date": "19/09/2018", "general_url": "https://www.ema.europa.eu/en/adequacy-mahalanobis-distance-assess-comparability-drug-dissolution-profiles-scientific-guideline" }, { "title": "Heads of Medicines Agencies", "summary": "The Heads of Medicines Agencies (HMA) is a network of the heads of the 'national competent authorities', the agencies responsible for the regulation of human and veterinary medicines in the individual countries of the European Economic Area (EEA).", "categories": "Corporate", "first_published_date": "01/12/2009", "last_updated_date": "28/08/2018", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states/heads-medicines-agencies" }, { "title": "Biosimilar medicinal products containing recombinant granulocyte-colony stimulating factor (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues)", "summary": "", "categories": "Human", "first_published_date": "22/02/2006", "last_updated_date": "15/08/2018", "general_url": "https://www.ema.europa.eu/en/biosimilar-medicinal-products-containing-recombinant-granulocyte-colony-stimulating-factor-annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active" }, { "title": "Procedure for the review and revision of European Union herbal monographs and European Union list entries", "summary": "", "categories": "Human;Herbal", "first_published_date": "14/08/2018", "last_updated_date": "14/08/2018", "general_url": "https://www.ema.europa.eu/en/procedure-review-revision-european-union-herbal-monographs-european-union-list-entries" }, { "title": "Core summary for product characteristics for human albumin solution - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/11/2005", "last_updated_date": "13/08/2018", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-albumin-solution-scientific-guideline" }, { "title": "Clinical investigation of recombinant and human plasma-derived factor VIII products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2016", "last_updated_date": "13/08/2018", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-recombinant-human-plasma-derived-factor-viii-products-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma-derived and recombinant coagulation factor VIII products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2016", "last_updated_date": "13/08/2018", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-recombinant-coagulation-factor-viii-products-scientific-guideline" }, { "title": "Vismodegib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "31/01/2018", "last_updated_date": "03/08/2018", "general_url": "https://www.ema.europa.eu/en/vismodegib-product-specific-bioequivalence-guidance" }, { "title": "Access to EudraVigilance data", "summary": "Stakeholders including marketing authorisation holders, regulatory authorities, academia, healthcare professionals and patients can access data held in the EudraVigilance database, based on the European Medicines Agency's (EMA) EudraVigilance access policy. The policy is designed to provide as much information as possible while meeting data protection obligations.", "categories": "Human", "first_published_date": "17/06/2016", "last_updated_date": "23/07/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development/eudravigilance/access-eudravigilance-data" }, { "title": "Similar biological medicinal products containing recombinant erythropoietins - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/04/2010", "last_updated_date": "23/07/2018", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-recombinant-erythropoietins-scientific-guideline" }, { "title": "Similar medicinal products containing somatropin (Annex to guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/02/2006", "last_updated_date": "20/07/2018", "general_url": "https://www.ema.europa.eu/en/similar-medicinal-products-containing-somatropin-annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-clinical-issues" }, { "title": "Reducing the use of antimicrobial agents in animal husbandry", "summary": "", "categories": "Human", "first_published_date": "17/07/2018", "last_updated_date": "17/07/2018", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/advice-impacts-using-antimicrobials-animals/reducing-use-antimicrobial-agents-animal-husbandry" }, { "title": "Clinical investigation of medicinal products for the treatment of axial spondyloarthritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/04/2009", "last_updated_date": "13/07/2018", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-axial-spondyloarthritis-scientific-guideline" }, { "title": "Quality, preclinical and clinical aspects of gene therapy medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/04/2001", "last_updated_date": "13/07/2018", "general_url": "https://www.ema.europa.eu/en/quality-preclinical-clinical-aspects-gene-therapy-medicinal-products-scientific-guideline" }, { "title": "Regulatory requirements for the development of medicinal products for Acute Kidney Injury (AKI) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/07/2018", "last_updated_date": "09/07/2018", "general_url": "https://www.ema.europa.eu/en/regulatory-requirements-development-medicinal-products-acute-kidney-injury-aki-scientific-guideline" }, { "title": "Use of aminoglycosides in animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/07/2014", "last_updated_date": "05/07/2018", "general_url": "https://www.ema.europa.eu/en/use-aminoglycosides-animals-european-union-development-resistance-impact-human-animal-health-scientific-guideline" }, { "title": "Pegylated liposomal doxorubicin hydrochloride product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "05/07/2018", "last_updated_date": "05/07/2018", "general_url": "https://www.ema.europa.eu/en/pegylated-liposomal-doxorubicin-hydrochloride-product-specific-bioequivalence-guidance" }, { "title": "Procurement activities 2017", "summary": "", "categories": "Corporate", "first_published_date": "03/02/2017", "last_updated_date": "28/06/2018", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2017" }, { "title": "Paliperidone product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "26/06/2018", "general_url": "https://www.ema.europa.eu/en/paliperidone-product-specific-bioequivalence-guidance" }, { "title": "Dimethyl fumarate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "03/08/2017", "last_updated_date": "26/06/2018", "general_url": "https://www.ema.europa.eu/en/dimethyl-fumarate-product-specific-bioequivalence-guidance" }, { "title": "Public hearings", "summary": "Public hearings enable the European Medicines Agency (EMA) to engage EU citizens in medicine safety reviews. The Pharmacovigilance Risk Assessment Committee (PRAC) holds these hearings, gathering public insights to aid decision-making. PRAC decides on hearings case-by-case, and citizens can register to participate. Hearings, held in English and broadcast live, enhance transparency and public confidence in EMA’s regulatory decisions by addressing benefit-risk considerations and safety measures.", "categories": "Corporate", "first_published_date": "15/04/2016", "last_updated_date": "20/06/2018", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/public-hearings" }, { "title": "Benefit-risk methodology", "summary": "The European Medicines Agency's opinions are based on balancing the desired effects or 'benefits' of a medicine against its undesired effects or 'risks'. The Agency can recommend the authorisation of a medicine whose benefits are judged to be greater than its risks. In contrast, a medicine whose risks outweigh its benefits cannot be recommended for marketing.", "categories": "Human", "first_published_date": "13/10/2010", "last_updated_date": "18/06/2018", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/benefit-risk-methodology" }, { "title": "Availability of veterinary medicinal products - extrapolation of maximum residue limits - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/06/2018", "last_updated_date": "18/06/2018", "general_url": "https://www.ema.europa.eu/en/availability-veterinary-medicinal-products-extrapolation-maximum-residue-limits-scientific-guideline" }, { "title": "ICH guideline E17 on general principles for planning and design of multi-regional clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/07/2016", "last_updated_date": "14/06/2018", "general_url": "https://www.ema.europa.eu/en/ich-guideline-e17-general-principles-planning-design-multi-regional-clinical-trials-scientific-guideline" }, { "title": "SPOR user registration", "summary": "Users can access the European Medicines Agency's (EMA) available master data services via the substance, product, organisation and referential (SPOR) portal. All users have read-only access. However, users need to register to carry out actions via the portal such as requesting changes to the master data held by EMA.", "categories": "Human;Veterinary", "first_published_date": "08/06/2018", "last_updated_date": "08/06/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/spor-user-registration" }, { "title": "ICH S9 Non-clinical evaluation for anticancer pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "16/05/2018", "general_url": "https://www.ema.europa.eu/en/ich-s9-non-clinical-evaluation-anticancer-pharmaceuticals-scientific-guideline" }, { "title": "Market exclusivity: orphan medicines", "summary": "", "categories": "Human", "first_published_date": "14/05/2018", "last_updated_date": "14/05/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/orphan-designation-post-authorisation/market-exclusivity-orphan-medicines" }, { "title": "Reporting a quality defect to EMA", "summary": "Marketing and manufacturing authorisation holders should report a quality defect of a centrally authorised medicine, including suspected defects, to EMA following the instructions provided.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "03/05/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation/quality-defects-recalls/reporting-quality-defect-ema" }, { "title": "Ethical use of animals in medicine testing", "summary": "", "categories": "", "first_published_date": "20/04/2018", "last_updated_date": "20/04/2018", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/ethical-use-animals-medicine-testing" }, { "title": "Indications for veterinary vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/04/2018", "last_updated_date": "16/04/2018", "general_url": "https://www.ema.europa.eu/en/indications-veterinary-vaccines-scientific-guideline" }, { "title": "Guidance for individual laboratories for transfer of quality control methods validated in collaborative trials with a view to implementing 3Rs - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/04/2018", "last_updated_date": "06/04/2018", "general_url": "https://www.ema.europa.eu/en/guidance-individual-laboratories-transfer-quality-control-methods-validated-collaborative-trials-view-implementing-3rs-scientific-guideline" }, { "title": "Public consultation concerning the European Union template for good manufacturing practice (GMP) non-compliance statement", "summary": "", "categories": "Human", "first_published_date": "03/04/2018", "last_updated_date": "03/04/2018", "general_url": "https://www.ema.europa.eu/en/public-consultation-concerning-european-union-template-good-manufacturing-practice-gmp-non-compliance-statement" }, { "title": "Core SmPC and package leaflet for sodium iodide (131 I) for therapeutic use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/03/2018", "last_updated_date": "22/03/2018", "general_url": "https://www.ema.europa.eu/en/core-smpc-package-leaflet-sodium-iodide-131-i-therapeutic-use-scientific-guideline" }, { "title": "Clinical investigation of medicinal products in the treatment of chronic heart failure - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/12/1999", "last_updated_date": "01/03/2018", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-chronic-heart-failure-scientific-guideline" }, { "title": "Clinical investigation of new medicinal products for the treatment of acute coronary syndrome - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/02/2000", "last_updated_date": "01/03/2018", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-new-medicinal-products-treatment-acute-coronary-syndrome-scientific-guideline" }, { "title": "Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/12/2015", "last_updated_date": "22/02/2018", "general_url": "https://www.ema.europa.eu/en/physical-frailty-instruments-baseline-characterisation-older-populations-clinical-trials-scientific-guideline" }, { "title": "International Pharmaceutical Regulators Programme (IPRP)", "summary": "", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "12/02/2018", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-and-initiatives/international-pharmaceutical-regulators-programme-iprp" }, { "title": "Pharmacovigilance for advanced therapies", "summary": "", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/advanced-therapies-post-authorisation/pharmacovigilance-advanced-therapies" }, { "title": "Guideline on safety and efficacy follow-up and risk management of advanced therapy medicinal products - Scientific guideline", "summary": "The guideline describes specific aspects of pharmacovigilance, risk management planning, safety and efficacy follow-up of authorised ATMPs, as well as some aspects of clinical follow-up of patients treated with such products.", "categories": "Human", "first_published_date": "01/02/2018", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/guideline-safety-efficacy-follow-risk-management-advanced-therapy-medicinal-products-scientific-guideline" }, { "title": "Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2018", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/reflection-paper-investigation-pharmacokinetics-obese-population-scientific-guideline" }, { "title": "Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacterium Tuberculosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-specifically-address-clinical-development-new-agents-treat-disease-due-mycobacterium-tuberculosis" }, { "title": "Influenza vaccines - quality module - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/06/2014", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/influenza-vaccines-quality-module-scientific-guideline" }, { "title": "Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/07/2007", "last_updated_date": "01/02/2018", "general_url": "https://www.ema.europa.eu/en/strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational-medicinal-products-scientific-guideline" }, { "title": "Paediatric medicines: Workshops", "summary": "", "categories": "Human", "first_published_date": "08/04/2010", "last_updated_date": "31/01/2018", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/paediatric-medicines-overview/paediatric-medicines-workshops" }, { "title": "Agomelatine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "31/01/2018", "last_updated_date": "31/01/2018", "general_url": "https://www.ema.europa.eu/en/agomelatine-product-specific-bioequivalence-guidance" }, { "title": "Posaconazole product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "31/01/2018", "last_updated_date": "31/01/2018", "general_url": "https://www.ema.europa.eu/en/posaconazole-product-specific-bioequivalence-guidance-0" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) macrosalb - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2018", "last_updated_date": "24/01/2018", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-technetium-99mtc-macrosalb-scientific-guideline" }, { "title": "Use of methyl- and propylparaben as excipients in human medicinal products for oral use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/01/2018", "last_updated_date": "23/01/2018", "general_url": "https://www.ema.europa.eu/en/use-methyl-propylparaben-excipients-human-medicinal-products-oral-use-scientific-guideline" }, { "title": "Classification of changes for veterinary medicines", "summary": "", "categories": "", "first_published_date": "21/12/2017", "last_updated_date": "21/12/2017", "general_url": "https://www.ema.europa.eu/en/classification-changes-veterinary-medicines" }, { "title": "Questions and answers: Article 35 veterinary referral procedures", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2017", "last_updated_date": "20/12/2017", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/referral-procedures-veterinary-medicines/questions-answers-article-35-veterinary-referral-procedures" }, { "title": "European medicines regulatory network", "summary": "The system for regulating medicines in Europe is unique in the world. It is based on a closely-coordinated regulatory network of national competent authorities in the Member States of the European Economic Area (EEA) working together with the European Medicines Agency (EMA) and the European Commission.", "categories": "Human;Veterinary;Corporate", "first_published_date": "07/03/2016", "last_updated_date": "19/12/2017", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/european-medicines-regulatory-network" }, { "title": "Improving quality of submissions", "summary": "To assist applicants preparing their submissions, the European Medicines Agency (EMA) has published pre-submission checklists for certain procedure types.", "categories": "Human", "first_published_date": "18/03/2011", "last_updated_date": "11/12/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/improving-quality-submissions" }, { "title": "Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/02/2016", "last_updated_date": "11/12/2017", "general_url": "https://www.ema.europa.eu/en/monoclonal-antibodies-veterinary-use-specific-questions-be-addressed-ad-hoc-expert-group-veterinary" }, { "title": "Horizon 2020 research funding", "summary": "", "categories": "", "first_published_date": "06/12/2017", "last_updated_date": "06/12/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/academia/horizon-2020-research-funding" }, { "title": "Juvenile animal studies (JAS) and impact on anti-cancer medicine development and use in children - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/2017", "last_updated_date": "30/11/2017", "general_url": "https://www.ema.europa.eu/en/juvenile-animal-studies-jas-impact-anti-cancer-medicine-development-use-children-scientific-guideline" }, { "title": "Assessment of clinical safety and efficacy in the preparation of EU herbal monographs for well-established and traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "07/09/2006", "last_updated_date": "28/11/2017", "general_url": "https://www.ema.europa.eu/en/assessment-clinical-safety-efficacy-preparation-eu-herbal-monographs-well-established-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Data submission on authorised medicines (Article 57)", "summary": "All holders of marketing authorisations for medicines in the European Union (EU) and the European Economic Area (EEA) must submit information to the European Medicines Agency (EMA) on authorised medicines and keep this information up-to-date. This is a legally binding requirement from the EU pharmaceutical legislation. The Agency uses this information to support the analysis of data, regulatory activities and communication.", "categories": "Human", "first_published_date": "01/07/2011", "last_updated_date": "22/11/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/data-submission-authorised-medicines-article-57" }, { "title": "Allogenic mesenchymal stem cell-based products for veterinary use: specific questions on tumorigenicity - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "21/11/2017", "last_updated_date": "21/11/2017", "general_url": "https://www.ema.europa.eu/en/allogenic-mesenchymal-stem-cell-based-products-veterinary-use-specific-questions-tumorigenicity" }, { "title": "Clinical development of medicinal products for the treatment of autism spectrum disorder (ASD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/03/2016", "last_updated_date": "21/11/2017", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-treatment-autism-spectrum-disorder-asd-scientific-guideline" }, { "title": "Manufacture of the finished dosage form (human) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/04/1996", "last_updated_date": "17/11/2017", "general_url": "https://www.ema.europa.eu/en/manufacture-finished-dosage-form-human-scientific-guideline" }, { "title": "Technical anonymisation group", "summary": "", "categories": "Human", "first_published_date": "31/10/2017", "last_updated_date": "31/10/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/technical-anonymisation-group" }, { "title": "Development of a reflection paper on new analytical methods/technologies in the quality control of herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "31/10/2017", "last_updated_date": "31/10/2017", "general_url": "https://www.ema.europa.eu/en/development-reflection-paper-new-analytical-methods-technologies-quality-control-herbal-medicinal-products-scientific-guideline" }, { "title": "Innovation in veterinary medicines", "summary": "One of the European Medicines Agency's (EMA) strategic goals is to promote development of innovative veterinary medicines and new technologies. Technologies that are new to veterinary medicine present particular challenges due to a lack of regulatory guidance and, in some cases, the fact that the existing regulatory framework does not specifically cater for them.", "categories": "Veterinary", "first_published_date": "21/07/2016", "last_updated_date": "25/10/2017", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/innovation-veterinary-medicines" }, { "title": "Clinical investigation of medicinal products for treatment of migraine - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2007", "last_updated_date": "21/10/2017", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-migraine-scientific-guideline" }, { "title": "Advanced therapies: research and development", "summary": "", "categories": "", "first_published_date": "09/02/2017", "last_updated_date": "20/10/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/advanced-therapies-research-development" }, { "title": "Sodium used as an excipient in medicinal products for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/06/2015", "last_updated_date": "10/10/2017", "general_url": "https://www.ema.europa.eu/en/sodium-used-excipient-medicinal-products-human-use-scientific-guideline" }, { "title": "Cyclodextrins - Scientific guideline", "summary": "", "categories": "", "first_published_date": "01/12/2014", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/cyclodextrins-scientific-guideline" }, { "title": "Benzoic acid and benzoates - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/02/2014", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/benzoic-acid-benzoates-scientific-guideline" }, { "title": "Fragrances containing allergens - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/05/2016", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/fragrances-containing-allergens-scientific-guideline" }, { "title": "Fructose and sorbitol - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/05/2016", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/fructose-sorbitol-scientific-guideline" }, { "title": "Benzyl alcohol - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/02/2014", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/benzyl-alcohol-scientific-guideline" }, { "title": "Propylene glycol and esters - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2014", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/propylene-glycol-esters-scientific-guideline" }, { "title": "Wheat starch containing gluten - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/08/2014", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/wheat-starch-containing-gluten-scientific-guideline" }, { "title": "Phosphates - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/10/2017", "last_updated_date": "09/10/2017", "general_url": "https://www.ema.europa.eu/en/phosphates-scientific-guideline" }, { "title": "Japan", "summary": "The European Commission and European Medicines Agency (EMA) have had confidentiality arrangements with the Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) since 2007, to allow the exchange of information between the parties as part of their regulatory and scientific processes. The European Union (EU) and Japan also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "06/10/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/japan" }, { "title": "Fellowships", "summary": "", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "06/10/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/fellowships" }, { "title": "ICH E18 Guideline on genomic sampling and management of genomic data - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2016", "last_updated_date": "06/10/2017", "general_url": "https://www.ema.europa.eu/en/ich-e18-guideline-genomic-sampling-management-genomic-data-scientific-guideline" }, { "title": "ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/01/2001", "last_updated_date": "06/10/2017", "general_url": "https://www.ema.europa.eu/en/ich-e11r1-guideline-clinical-investigation-medicinal-products-pediatric-population-scientific-guideline" }, { "title": "ICH Q11 Development and manufacture of drug substances (chemical entities and biotechnological/biological entities) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "06/10/2017", "general_url": "https://www.ema.europa.eu/en/ich-q11-development-manufacture-drug-substances-chemical-entities-biotechnological-biological-entities-scientific-guideline" }, { "title": "Medicines assessed under the ‘EU-M4all’ procedure", "summary": "The European Medicines Agency (EMA), in cooperation with the World Health Organization (WHO), can provide scientific opinions on high priority human medicines, including vaccines, that are intended for markets outside of the European Union (EU).", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/medicines-assessed-under-eu-m4all-procedure" }, { "title": "International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)", "summary": "", "categories": "Veterinary", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-cooperation-harmonisation-technical-requirements-registration-veterinary-medicinal-products-vich" }, { "title": "Russia", "summary": "", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/russia" }, { "title": "Australia", "summary": "The European Medicines Agency and the European Commission have had confidentiality arrangements with the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Aged Care since 2012, to allow the exchange of information between the parties as part of their regulatory and scientific processes. The European Union (EU) and Australia also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/australia" }, { "title": "The Pharmaceutical Inspection Co-operation Scheme", "summary": "", "categories": "", "first_published_date": "10/09/2010", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-and-initiatives/pharmaceutical-inspection-co-operation-scheme" }, { "title": "Codex Alimentarius", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-and-initiatives/codex-alimentarius" }, { "title": "New Zealand", "summary": "The European Union (EU) and the New Zealand Ministry of Health and Ministry for Primary Industries put in place a mutual recognition agreement (MRA) in 2002 on good manufacturing practice (GMP) compliance.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/new-zealand" }, { "title": "International agreements", "summary": "The European Medicines Agency (EMA) cooperates with a number of countries and organisations outside the European Union (EU) based on specific types of agreement, which enable the signatories to share confidential information or facilitate market access and achieve greater international harmonisation while protecting consumer safety.", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "26/04/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/international-agreements" }, { "title": "World Organisation for Animal Health (OIE)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-and-initiatives/world-organisation-animal-health-oie" }, { "title": "Switzerland", "summary": "The European Commission, European Medicines Agency (EMA), Swiss Federal Department of Home Affairs (FDHA) and the Swiss Agency for Therapeutic Products (Swissmedic) have had confidentiality arrangements in place since 2015, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European Union (EU) and Switzerland also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/switzerland" }, { "title": "India", "summary": "The European Medicines Agency (EMA) supports the European Commission's activities in India, by contributing to interactions on pharmaceuticals between the European Union (EU) and the regulatory authorities of India.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/india" }, { "title": "International activities", "summary": "A central pillar in the European Medicines Agency's (EMA) strategy to protect public health is the strengthening of collaboration at international level to promote harmonisation of regulatory requirements, sharing of information and addressing common challenges.", "categories": "", "first_published_date": "09/06/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities" }, { "title": "Israel", "summary": "The European Union (EU) has an agreement on conformity assessment and acceptance of industrial products in place with Israel. This agreement recognises Israel's industrial standards as being equivalent to European standards.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "28/09/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/israel" }, { "title": "Research and development", "summary": "The European Medicines Agency (EMA) provides guidance and support to medicine developers. This includes scientific and regulatory information on how to design and run clinical trials, compliance standards, and obligations and incentives for developers of specialised medicines.", "categories": "Human", "first_published_date": "22/11/2016", "last_updated_date": "26/09/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development" }, { "title": "External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use", "summary": "", "categories": "Human", "first_published_date": "21/12/2016", "last_updated_date": "22/09/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/support-industry-clinical-data-publication/external-guidance-implementation-european-medicines-agency-policy-publication-clinical-data-medicinal-products-human-use" }, { "title": "Core summary of product characteristics and package leaflet for (68Ge/68Ga) generator - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "08/09/2017", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-package-leaflet-68ge-68ga-generator-scientific-guideline" }, { "title": "Dissolution specification for generic oral immediate release products - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/05/2016", "last_updated_date": "15/08/2017", "general_url": "https://www.ema.europa.eu/en/dissolution-specification-generic-oral-immediate-release-products-scientific-guideline" }, { "title": "Predictive biomarker-based assay development in the context of drug development and lifecycle", "summary": "", "categories": "Human", "first_published_date": "28/07/2017", "last_updated_date": "28/07/2017", "general_url": "https://www.ema.europa.eu/en/predictive-biomarker-based-assay-development-context-drug-development-lifecycle" }, { "title": "Co-development of pharmacogenomic biomarkers and assays in the context of drug development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/07/2011", "last_updated_date": "28/07/2017", "general_url": "https://www.ema.europa.eu/en/co-development-pharmacogenomic-biomarkers-assays-context-drug-development-scientific-guideline" }, { "title": "Logo and visual identity", "summary": "The European Medicines Agency (EMA) launched its current visual identity on 8 December 2009. This supports EMA's communication activities by visually representing the Agency's role and character.", "categories": "Corporate", "first_published_date": "08/12/2009", "last_updated_date": "28/07/2017", "general_url": "https://www.ema.europa.eu/en/about-us/legal/logo-visual-identity" }, { "title": "ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide - Scientific guideline", "summary": "This document provides guidance on the implementation of the standard adopted by the ICH for electronic transmission of individual case safety reports (ICSRs).", "categories": "Human", "first_published_date": "01/09/2005", "last_updated_date": "27/07/2017", "general_url": "https://www.ema.europa.eu/en/ich-e2b-r3-electronic-transmission-individual-case-safety-reports-icsrs-data-elements-message-specification-implementation-guide-scientific-guideline" }, { "title": "Data on medicines (ISO IDMP standards): research and development", "summary": "", "categories": "Human", "first_published_date": "20/07/2017", "last_updated_date": "20/07/2017", "general_url": "https://www.ema.europa.eu/en/data-medicines-iso-idmp-standards-research-development" }, { "title": "Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "10/07/2017", "general_url": "https://www.ema.europa.eu/en/elvitegravir-cobicistat-emtricitabine-tenofovir-disoproxil-product-specific-bioequivalence-guidance" }, { "title": "Elvitegravir product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "10/07/2017", "general_url": "https://www.ema.europa.eu/en/elvitegravir-product-specific-bioequivalence-guidance" }, { "title": "Crizotinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "22/12/2016", "last_updated_date": "10/07/2017", "general_url": "https://www.ema.europa.eu/en/crizotinib-product-specific-bioequivalence-guidance" }, { "title": "Addendum on terms and concepts of pharmacogenomic features related to metabolism to the Guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/07/2017", "last_updated_date": "07/07/2017", "general_url": "https://www.ema.europa.eu/en/addendum-terms-concepts-pharmacogenomic-features-related-metabolism-guideline-use-pharmacogenetic-methodologies-pharmacokinetic-evaluation-medicinal-products-scientific-guideline" }, { "title": "SPOR (ISO IDMP) Task Force", "summary": "The European Medicines Agency (EMA) and European medicines regulatory network are pursuing an open dialogue with industry and all stakeholders to discuss aspects of implementing the ISO IDMP standards in the EU through the substance, product, organisation and referential (SPOR) programme.", "categories": "Human;Veterinary", "first_published_date": "07/07/2017", "last_updated_date": "07/07/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview/substance-product-organisation-referential-spor-master-data/spor-iso-idmp-task-force" }, { "title": "Data on medicines (ISO IDMP standards): Overview", "summary": "The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organisation for Standardisation (ISO) for the identification of medicinal products (IDMP).", "categories": "Human", "first_published_date": "06/07/2017", "last_updated_date": "06/07/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/data-medicines-iso-idmp-standards-overview" }, { "title": "Substance, product, organisation and referential (SPOR) master data", "summary": "", "categories": "Veterinary", "first_published_date": "05/07/2017", "last_updated_date": "05/07/2017", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/substance-product-organisation-referential-spor-master-data" }, { "title": "Cluster activities", "summary": "The European Medicines Agency (EMA) holds regular meetings by phone or videoconference with other non-EU regulators in so-called 'clusters'. The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.", "categories": "", "first_published_date": "29/09/2015", "last_updated_date": "03/07/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/cluster-activities" }, { "title": "Data on medicines (ISO IDMP standards): marketing authorisation", "summary": "The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP).", "categories": "Human", "first_published_date": "20/06/2017", "last_updated_date": "20/06/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/data-medicines-iso-idmp-standards-marketing-authorisation" }, { "title": "Data on medicines (ISO IDMP standards): post-authorisation", "summary": "", "categories": "Human", "first_published_date": "20/06/2017", "last_updated_date": "20/06/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation" }, { "title": "Quality by design", "summary": "", "categories": "", "first_published_date": "01/06/2017", "last_updated_date": "01/06/2017", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/quality-design" }, { "title": "PRAC recommendations on safety signals: monthly overviews: Archive", "summary": "", "categories": "", "first_published_date": "30/05/2017", "last_updated_date": "30/05/2017", "general_url": "https://www.ema.europa.eu/en/prac-recommendations-safety-signals-monthly-overviews-archive" }, { "title": "Authorisation of veterinary medicinal products containing (potential) persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/02/2016", "last_updated_date": "23/05/2017", "general_url": "https://www.ema.europa.eu/en/authorisation-veterinary-medicinal-products-containing-potential-persistent-bioaccumulative-toxic-pbt-or-very-persistent-very-bioaccumulative-vpvb-substances-scientific-guideline" }, { "title": "Procurement activities 2016", "summary": "", "categories": "Corporate", "first_published_date": "01/03/2016", "last_updated_date": "18/05/2017", "general_url": "https://www.ema.europa.eu/en/about-us/procurement/procurement-archive/procurement-activities-2016" }, { "title": "Transparency: questions and answers", "summary": "", "categories": "Veterinary", "first_published_date": "01/01/2016", "last_updated_date": "16/05/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transparency-questions-answers" }, { "title": "Generic and hybrid medicines", "summary": "", "categories": "Human", "first_published_date": "12/03/2012", "last_updated_date": "12/05/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/generic-hybrid-medicines" }, { "title": "Role of pharmacokinetics in the development of medicinal products in the paediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/06/2006", "last_updated_date": "04/05/2017", "general_url": "https://www.ema.europa.eu/en/role-pharmacokinetics-development-medicinal-products-paediatric-population-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for iopamidol 300 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/04/2017", "last_updated_date": "26/04/2017", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-iopamidol-300-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for iopamidol 370 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/04/2017", "last_updated_date": "26/04/2017", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-iopamidol-370-scientific-guideline" }, { "title": "Anthelmintic resistance - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/04/2014", "last_updated_date": "24/04/2017", "general_url": "https://www.ema.europa.eu/en/anthelmintic-resistance-scientific-guideline" }, { "title": "Data requirements for immunological veterinary medicinal products intended for minor use or minor species - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/04/2010", "last_updated_date": "21/04/2017", "general_url": "https://www.ema.europa.eu/en/data-requirements-immunological-veterinary-medicinal-products-intended-minor-use-or-minor-species-scientific-guideline" }, { "title": "Quality by design", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "19/04/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/quality-design" }, { "title": "Investigation of drug interactions - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2012", "last_updated_date": "07/04/2017", "general_url": "https://www.ema.europa.eu/en/investigation-drug-interactions-scientific-guideline" }, { "title": "Resources for academia", "summary": "The European Medicines Agency (EMA) makes available resource materials including videos and links to workshops for academics and researchers interested in learning more about EMA activities.", "categories": "", "first_published_date": "03/04/2017", "last_updated_date": "03/04/2017", "general_url": "https://www.ema.europa.eu/en/partners-networks/academia/resources-academia" }, { "title": "Multiplicity issues in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/09/2002", "last_updated_date": "31/03/2017", "general_url": "https://www.ema.europa.eu/en/multiplicity-issues-clinical-trials-scientific-guideline" }, { "title": "Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man - condition specific guidance - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/02/2016", "last_updated_date": "31/03/2017", "general_url": "https://www.ema.europa.eu/en/appendix-4-guideline-evaluation-anticancer-medicinal-products-man-condition-specific-guidance-scientific-guideline" }, { "title": "Compliance: overview (veterinary medicines)", "summary": "All organisations involved in the development, marketing, manufacture and distribution of veterinary medicines are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines on pharmaceuticals. The European Medicines Agency (EMA) is responsible for harmonising these standards at EU level. It also coordinates inspections to verify compliance.", "categories": "Veterinary", "first_published_date": "14/12/2016", "last_updated_date": "31/03/2017", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/compliance-overview-veterinary-medicines" }, { "title": "Compliance: post-authorisation", "summary": "Marketing authorisation holders, manufacturers and distributors are responsible for ensuring that they comply with all relevant standards set out in European Union (EU) legislation and guidelines once the medicine is on the market, including good manufacturing practice (GMP), good distribution practice (GDP) and good pharmacovigilance practices (GVP).", "categories": "", "first_published_date": "31/03/2017", "last_updated_date": "31/03/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/compliance-post-authorisation" }, { "title": "Compliance: research and development", "summary": "Medicine developers are responsible for ensuring that they and any parties working for them comply with standards set out in European Union (EU) legislation and guidelines for good clinical practice (GCP), good laboratory practice (GLP) and good manufacturing practice (GMP) for investigational medicinal products.", "categories": "Human", "first_published_date": "31/03/2017", "last_updated_date": "31/03/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development" }, { "title": "Pharmacovigilance: post-authorisation", "summary": "European Union (EU) legislation requires marketing authorisation holders, national competent authorities and the European Medicines Agency (EMA) to follow a number of pharmacovigilance processes after a product has been authorised.", "categories": "Human", "first_published_date": "28/03/2017", "last_updated_date": "28/03/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation" }, { "title": "Pharmacovigilance: research and development", "summary": "Sponsors of clinical trials must submit reports of suspected unexpected serious adverse reactions to EudraVigilance, the electronic system for managing and analysing information on suspected adverse reactions to medicines in the European Economic Area (EEA).", "categories": "Human", "first_published_date": "28/03/2017", "last_updated_date": "28/03/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-research-development" }, { "title": "Influenza vaccines – submission and procedural requirements - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/07/2015", "last_updated_date": "14/03/2017", "general_url": "https://www.ema.europa.eu/en/influenza-vaccines-submission-procedural-requirements-scientific-guideline" }, { "title": "Exenatide product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/08/2016", "last_updated_date": "03/03/2017", "general_url": "https://www.ema.europa.eu/en/exenatide-product-specific-bioequivalence-guidance" }, { "title": "Vandetanib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/08/2016", "last_updated_date": "03/03/2017", "general_url": "https://www.ema.europa.eu/en/vandetanib-product-specific-bioequivalence-guidance" }, { "title": "Vemurafenib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/08/2016", "last_updated_date": "03/03/2017", "general_url": "https://www.ema.europa.eu/en/vemurafenib-product-specific-bioequivalence-guidance" }, { "title": "Paliperidone palmitate product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "01/08/2016", "last_updated_date": "03/03/2017", "general_url": "https://www.ema.europa.eu/en/paliperidone-palmitate-product-specific-bioequivalence-guidance" }, { "title": "VICH GL56 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing species: study design recommendations for residue studies in honey for establishing MRLs and withdrawal periods - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "24/02/2017", "last_updated_date": "24/02/2017", "general_url": "https://www.ema.europa.eu/en/vich-gl56-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-species-study-design-recommendations-residue-studies-honey-establishing-mrls-withdrawal-periods-scientific" }, { "title": "Adaptive pathways", "summary": "The adaptive pathways approach is part of the European Medicines Agency's (EMA) efforts to improve timely access for patients to new medicines. Adaptive pathways is a scientific concept for medicine development and data generation which allows for early and progressive patient access to a medicine. The approach makes use of the existing European Union (EU) regulatory framework for medicines.", "categories": "Human", "first_published_date": "12/05/2014", "last_updated_date": "23/02/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/adaptive-pathways" }, { "title": "Development of a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/02/2017", "last_updated_date": "16/02/2017", "general_url": "https://www.ema.europa.eu/en/development-guideline-quality-requirements-medicinal-products-containing-device-component-delivery-or-use-medicinal-product-scientific-guideline" }, { "title": "Advanced therapies: post-authorisation", "summary": "The European Medicines Agency's scientific and regulatory guidance on post-authorisation activities for human medicines marketed in the European Union apply to advanced therapy medicinal products (ATMPs). In addition, EMA has published specific guidance on pharmacovigilance for ATMPs.", "categories": "", "first_published_date": "09/02/2017", "last_updated_date": "09/02/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/advanced-therapies-post-authorisation" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for nanocolloidal technetium (99mTc) albumin - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2016", "last_updated_date": "03/02/2017", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-nanocolloidal-technetium-99mtc-albumin-scientific-guideline" }, { "title": "Medicine evaluation figures: archive 2010-2015", "summary": "", "categories": "Corporate", "first_published_date": "01/02/2017", "last_updated_date": "01/02/2017", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines/medicine-evaluation-figures/medicine-evaluation-figures-archive-2010-2015" }, { "title": "Quality: Quality by Design (QbD)", "summary": "", "categories": "Human", "first_published_date": "19/01/2017", "last_updated_date": "19/01/2017", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-guidelines/quality-quality-design-qbd" }, { "title": "Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "24/11/2014", "last_updated_date": "09/01/2017", "general_url": "https://www.ema.europa.eu/en/setting-health-based-exposure-limits-use-risk-identification-manufacture-different-medicinal-products-shared-facilities-scientific-guideline" }, { "title": "Levodopa/carbidopa/entacapone product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "03/01/2017", "general_url": "https://www.ema.europa.eu/en/levodopa-carbidopa-entacapone-product-specific-bioequivalence-guidance" }, { "title": "Pazopanib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "30/11/2016", "last_updated_date": "03/01/2017", "general_url": "https://www.ema.europa.eu/en/pazopanib-product-specific-bioequivalence-guidance" }, { "title": "Clinical development of medicinal products intended for the treatment of pain - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/12/2015", "last_updated_date": "22/12/2016", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-intended-treatment-pain-scientific-guideline" }, { "title": "Scientific guidance on post-authorisation efficacy studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/11/2015", "last_updated_date": "22/12/2016", "general_url": "https://www.ema.europa.eu/en/scientific-guidance-post-authorisation-efficacy-studies-scientific-guideline" }, { "title": "Post-authorisation (veterinary medicines)", "summary": "The European Medicines Agency (EMA) provides scientific and regulatory guidance to pharmaceutical companies whose veterinary medicinal products have been authorised in Europe. This is known as the post-authorisation stage of the product lifecycle. The information in this section sets out the responsibilities of marketing authorisation holders in areas such as pharmacovigilance, applying to vary a marketing authorisation, submitting product data to EMA and reporting product defects or recalls.", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "20/12/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines" }, { "title": "Pharmacovigilance system (veterinary medicines)", "summary": "", "categories": "Veterinary", "first_published_date": "20/12/2016", "last_updated_date": "20/12/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/pharmacovigilance-system-veterinary-medicines" }, { "title": "VICH GL54 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish an acute reference dose (ARfD) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/03/2015", "last_updated_date": "19/12/2016", "general_url": "https://www.ema.europa.eu/en/vich-gl54-studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-acute-reference-dose-arfd-scientific-guideline" }, { "title": "Veterinary medicinal products for fluid therapy in case of diarrhoea - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/03/1992", "last_updated_date": "16/12/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-medicinal-products-fluid-therapy-case-diarrhoea-scientific-guideline" }, { "title": "Time allowed for applicants to respond to questions and issues raised during the assessment of new marketing authorisation applications in the centralised procedure", "summary": "", "categories": "", "first_published_date": "12/12/2016", "last_updated_date": "12/12/2016", "general_url": "https://www.ema.europa.eu/en/time-allowed-applicants-respond-questions-issues-raised-during-assessment-new-marketing-authorisation-applications-centralised-procedure" }, { "title": "Guideline on the scientific application and the practical arrangements necessary to implement Regulation (EC) No 507/2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No ...", "summary": "", "categories": "", "first_published_date": "12/12/2016", "last_updated_date": "12/12/2016", "general_url": "https://www.ema.europa.eu/en/guideline-scientific-application-practical-arrangements-necessary-implement-regulation-ec-no-507-2006-conditional-marketing-authorisation-medicinal-products-human-use-falling-within-scope-regulation" }, { "title": "Guideline on the scientific application and the practical arrangements necessary to implement the procedure for accelerated assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004", "summary": "", "categories": "", "first_published_date": "12/12/2016", "last_updated_date": "12/12/2016", "general_url": "https://www.ema.europa.eu/en/guideline-scientific-application-practical-arrangements-necessary-implement-procedure-accelerated-assessment-pursuant-article-149-regulation-ec-no-726-2004" }, { "title": "Publications", "summary": "The European Medicines Agency (EMA) produces a range of publications such as newsletters and leaflets, to provide a snapshot of different areas of its work to stakeholders and other interested parties.", "categories": "Corporate", "first_published_date": "02/12/2016", "last_updated_date": "02/12/2016", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications" }, { "title": "Orphan designation: research and development", "summary": "The European Medicines Agency provides support, including regulatory guidance and incentives, for the research and development of medicines for rare diseases in the European Union (EU).", "categories": "", "first_published_date": "01/12/2016", "last_updated_date": "01/12/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development" }, { "title": "Orphan designation: post-authorisation", "summary": "The pages listed below are relevant for sponsors of medicines that have obtained orphan designation and are at the post-authorisation stage of the product lifecycle.", "categories": "", "first_published_date": "01/12/2016", "last_updated_date": "01/12/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/orphan-designation-post-authorisation" }, { "title": "Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in non-surgical patients - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "29/11/2016", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-prevention-venous-thromboembolism-vte-non-surgical-patients-scientific-guideline" }, { "title": "10 years of the Patients' and Consumers' Working Party", "summary": "2016 marked the 10th anniversary of the European Medicines Agency's (EMA) Patients' and Consumers' Working Party (PCWP). The PCWP is a unique platform for exchange with patients and consumers on medicine-related issues.", "categories": "Human", "first_published_date": "29/11/2016", "last_updated_date": "29/11/2016", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/comp-working-parties-other-groups/patients-consumers-working-party/10-years-patients-consumers-working-party" }, { "title": "Paediatric addendum on the CHMP guideline on clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/06/2015", "last_updated_date": "18/11/2016", "general_url": "https://www.ema.europa.eu/en/paediatric-addendum-chmp-guideline-clinical-investigation-medicinal-products-treatment-acute-heart-failure-scientific-guideline" }, { "title": "EU partners", "summary": "The European Medicines Agency (EMA) is a networking organisation, working in close cooperation with European Union (EU) institutions and Member States.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "07/11/2016", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners" }, { "title": "EU Institutions", "summary": "The European Medicines Agency (EMA) has close ties with all of the European Union (EU) institutions involved in developing EU laws concerning medicines and the regulation of medicines.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "07/11/2016", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-institutions" }, { "title": "Lenalidomide product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "01/11/2016", "general_url": "https://www.ema.europa.eu/en/lenalidomide-product-specific-bioequivalence-guidance" }, { "title": "Asenapine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "27/05/2016", "last_updated_date": "01/11/2016", "general_url": "https://www.ema.europa.eu/en/asenapine-product-specific-bioequivalence-guidance" }, { "title": "Background to clinical data publication policy", "summary": "", "categories": "Human", "first_published_date": "05/12/2012", "last_updated_date": "20/10/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/background-clinical-data-publication-policy" }, { "title": "Transparency", "summary": "Transparency is an important feature of the European Medicines Agency's operations. As for any public authority, the Agency strives towards being as open as possible about how it works and how it comes to its decisions.", "categories": "Corporate", "first_published_date": "10/05/2012", "last_updated_date": "20/10/2016", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/transparency" }, { "title": "Points to consider for assessors - New factor VIII and factor IX products: potency determination for labelling and assays for testing post-infusion samples - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/10/2016", "last_updated_date": "07/10/2016", "general_url": "https://www.ema.europa.eu/en/points-consider-assessors-new-factor-viii-factor-ix-products-potency-determination-labelling-assays-testing-post-infusion-samples-scientific-guideline" }, { "title": "Core summary of products characteristics for human anti-D immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2007", "last_updated_date": "29/09/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-products-characteristics-human-anti-d-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Core summary of product characteristics for human anti-D immunoglobulin for intravenous use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2007", "last_updated_date": "29/09/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-anti-d-immunoglobulin-intravenous-use-scientific-guideline" }, { "title": "Leaflets", "summary": "", "categories": "Corporate", "first_published_date": "29/03/2011", "last_updated_date": "23/09/2016", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/leaflets" }, { "title": "Zika", "summary": "On 1 February 2016, the World Health Organization (WHO) declared the Zika outbreak a public health emergency of international concern. The European Medicines Agency (EMA) is supporting the global response to the Zika outbreak with the creation of a group of specialised European scientific experts.", "categories": "Human", "first_published_date": "08/02/2016", "last_updated_date": "21/09/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/zika" }, { "title": "Production and quality control of animal immunoglobins and immunosera for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2002", "last_updated_date": "05/08/2016", "general_url": "https://www.ema.europa.eu/en/production-quality-control-animal-immunoglobins-immunosera-human-use-scientific-guideline" }, { "title": "Potency testing of cell-based immunotherapy medicinal products for the treatment of cancer - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/10/2007", "last_updated_date": "05/08/2016", "general_url": "https://www.ema.europa.eu/en/potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancer-scientific-guideline" }, { "title": "Renewals: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "11/05/2010", "last_updated_date": "04/08/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/renewal-annual-re-assessment-marketing-authorisation/renewals-regulatory-procedural-guidance" }, { "title": "Clinical development of medicinal products for the treatment of cystic fibrosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/11/2009", "last_updated_date": "01/08/2016", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-treatment-cystic-fibrosis-scientific-guideline" }, { "title": "VICH GL52 Bioequivalence: blood level bioequivalence study - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2015", "last_updated_date": "01/08/2016", "general_url": "https://www.ema.europa.eu/en/vich-gl52-bioequivalence-blood-level-bioequivalence-study-scientific-guideline" }, { "title": "Use of herbal medicinal products containing pulegone and menthofuran - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "27/07/2016", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-pulegone-menthofuran-scientific-guideline" }, { "title": "Use of pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2000", "last_updated_date": "26/07/2016", "general_url": "https://www.ema.europa.eu/en/use-pharmacokinetics-pharmacodynamics-development-antibacterial-medicinal-products-scientific-guideline" }, { "title": "EMEA implementation of electronic submissions: statements of intent - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/07/2016", "last_updated_date": "26/07/2016", "general_url": "https://www.ema.europa.eu/en/emea-implementation-electronic-submissions-statements-intent-scientific-guideline" }, { "title": "Stem cell-based products for veterinary use: specific questions on target animal safety to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)", "summary": "", "categories": "Veterinary", "first_published_date": "25/07/2016", "last_updated_date": "25/07/2016", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-questions-target-animal-safety-be-addressed-ad-hoc-expert-group-veterinary-novel-therapies-advent" }, { "title": "ICH: M 4: Common technical document for the registration of pharmaceuticals for human use: Organisation of CTD - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/ich-m-4-common-technical-document-registration-pharmaceuticals-human-use-organisation-ctd-scientific-guideline" }, { "title": "Preclinical pharmacological and toxicological testing of vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/1997", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/preclinical-pharmacological-toxicological-testing-vaccines-scientific-guideline" }, { "title": "ICH: M 4 S: Common technical document for the registration of pharmaceuticals for human use - Safety - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/ich-m-4-s-common-technical-document-registration-pharmaceuticals-human-use-safety-scientific-guideline" }, { "title": "Practical guidelines relating to non-eCTD electronic submissions - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/practical-guidelines-relating-non-ectd-electronic-submissions-scientific-guideline" }, { "title": "ICH: M 4 E: Common technical document for the registration of pharmaceuticals for human use - Efficacy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/ich-m-4-e-common-technical-document-registration-pharmaceuticals-human-use-efficacy-scientific-guideline" }, { "title": "ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/07/2016", "last_updated_date": "22/07/2016", "general_url": "https://www.ema.europa.eu/en/ich-m-4-q-common-technical-document-registration-pharmaceuticals-human-use-quality-scientific-guideline" }, { "title": "Product defects and recalls", "summary": "", "categories": "Veterinary", "first_published_date": "21/07/2016", "last_updated_date": "21/07/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/compliance-post-authorisation-veterinary-medicines/product-defects-recalls" }, { "title": "Support to research", "summary": "The European Medicines Agency (EMA) is involved in and supports a number of research projects with academia, learned societies and research groups.", "categories": "", "first_published_date": "15/03/2013", "last_updated_date": "13/07/2016", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/regulatory-science-research/support-research" }, { "title": "Active substance master file procedure - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/07/2016", "last_updated_date": "13/07/2016", "general_url": "https://www.ema.europa.eu/en/active-substance-master-file-procedure-scientific-guideline" }, { "title": "EudraVigilance Expert Working Group", "summary": "The EudraVigilance Expert Working Group (EV-EWG) advises the pharmacovigilance governance structure of the European medicines regulatory network on aspects of the EudraVigilance system.", "categories": "Human", "first_published_date": "08/07/2016", "last_updated_date": "08/07/2016", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/eudravigilance-expert-working-group" }, { "title": "Clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/01/2014", "last_updated_date": "08/07/2016", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-lipid-disorders-scientific-guideline" }, { "title": "Clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/12/2010", "last_updated_date": "08/07/2016", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-hypertension-scientific-guideline" }, { "title": "Questions and answers: Article 13 referral procedures", "summary": "", "categories": "Human;Veterinary", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-13-referral-procedures" }, { "title": "Questions and answers: Article 29(4) referral procedures", "summary": "", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-294-referral-procedures" }, { "title": "Questions and answers: Article 30 referral procedures", "summary": "", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-30-referral-procedures" }, { "title": "Questions and answers: Article 20 non-pharmacovigilance procedures", "summary": "", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "06/07/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-20-non-pharmacovigilance-procedures" }, { "title": "Immunologicals: guidelines - Stability", "summary": "The European Medicines Agency's scientific guidelines on the stability of immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/immunologicals-guidelines/immunologicals-guidelines-stability" }, { "title": "Quality: availability (limited markets)", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines/quality-availability-limited-markets" }, { "title": "Immunological guidelines: multidisciplinary", "summary": "The European Medicines Agency's scientific guidelines on immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/immunological-guidelines/immunological-guidelines-multidisciplinary" }, { "title": "Quality: post approval change management protocols", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/04/2012", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines/quality-post-approval-change-management-protocols" }, { "title": "Evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/02/2016", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of Duchenne and Becker muscular dystrophy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/12/2015", "last_updated_date": "01/07/2016", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-duchenne-becker-muscular-dystrophy-scientific-guideline" }, { "title": "Multidisciplinary guidelines: cell therapy and tissue engineering", "summary": "The European Medicines Agency's scientific guidelines on cell therapy and tissue engineering help medicine developers prepare marketing authorisation", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-cell-therapy-tissue-engineering" }, { "title": "Multidisciplinary guidelines: gene therapy", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-gene-therapy" }, { "title": "Multidisciplinary guidelines: orally inhaled products", "summary": "The European Medicines Agency's scientific guidelines on orally inhaled products help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-orally-inhaled-products" }, { "title": "Scientific guidelines: paediatrics", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/scientific-guidelines-paediatrics" }, { "title": "Multidisciplinary guidelines: biosimilar", "summary": "The European Medicines Agency's scientific guidelines on biosimilar medicinal products help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-biosimilar" }, { "title": "Multidisciplinary guidelines: pharmacogenomics", "summary": "The European Medicines Agency's scientific guidelines on pharmacogenomics (PG) help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-pharmacogenomics" }, { "title": "ICH guidelines: efficacy", "summary": "The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines/ich-guidelines-efficacy" }, { "title": "ICH: multidisciplinary guidelines", "summary": "", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines/ich-multidisciplinary-guidelines" }, { "title": "Polycyclic aromatic hydrocarbons in herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "29/06/2016", "last_updated_date": "29/06/2016", "general_url": "https://www.ema.europa.eu/en/polycyclic-aromatic-hydrocarbons-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Efficacy: multidisciplinary", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "28/06/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/efficacy-guidelines/efficacy-multidisciplinary" }, { "title": "Efficacy: veterinary limited markets", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "28/06/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/efficacy-guidelines/efficacy-veterinary-limited-markets" }, { "title": "Stem cell -based products for veterinary use: Specific questions on extraneous agents to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)", "summary": "", "categories": "Veterinary", "first_published_date": "27/06/2016", "last_updated_date": "27/06/2016", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-products-veterinary-use-specific-questions-extraneous-agents-be-addressed-ad-hoc-expert-group-veterinary-novel-therapies-advent" }, { "title": "Guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products", "summary": "", "categories": "", "first_published_date": "31/01/2016", "last_updated_date": "27/06/2016", "general_url": "https://www.ema.europa.eu/en/guideline-use-ctd-format-preparation-registration-application-traditional-herbal-medicinal-products" }, { "title": "Scientific guidelines: Antimicrobials", "summary": "", "categories": "Veterinary", "first_published_date": "27/06/2016", "last_updated_date": "27/06/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/scientific-guidelines-antimicrobials" }, { "title": "Biologicals: active substance", "summary": "", "categories": "Human", "first_published_date": "27/03/2010", "last_updated_date": "27/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guidelines/biologicals-active-substance" }, { "title": "Multidisciplinary guidelines: nanomedicines", "summary": "", "categories": "Human", "first_published_date": "01/02/2013", "last_updated_date": "26/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-guidelines-nanomedicines" }, { "title": "Structure of the list of herbal substances, preparations and combinations thereof", "summary": "", "categories": "Herbal", "first_published_date": "19/06/2016", "last_updated_date": "19/06/2016", "general_url": "https://www.ema.europa.eu/en/structure-list-herbal-substances-preparations-combinations-thereof" }, { "title": "COMP: meeting archive 2012-2014", "summary": "This is an archive of the monthly meeting reports, agendas and minutes from the Committee for Orphan Medicinal Products (COMP) from 2012 to 2014.", "categories": "Human", "first_published_date": "15/06/2016", "last_updated_date": "15/06/2016", "general_url": "https://www.ema.europa.eu/en/committees/committee-orphan-medicinal-products-comp/comp-meeting-archive-2012-2014" }, { "title": "CAT: meeting archive 2013-2016", "summary": "", "categories": "", "first_published_date": "15/06/2016", "last_updated_date": "15/06/2016", "general_url": "https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat/cat-meeting-archive-2013-2016" }, { "title": "HMPC: meeting archive 2012-2014", "summary": "This is an archive of the meeting reports from the European Medicines Agency's Committee on Herbal Medicinal Products (HMPC) from 2012 to 2014.", "categories": "Human;Herbal", "first_published_date": "15/06/2016", "last_updated_date": "15/06/2016", "general_url": "https://www.ema.europa.eu/en/committees/committee-herbal-medicinal-products-hmpc/hmpc-meeting-archive-2012-2014" }, { "title": "PDCO: meeting archive 2012-2014", "summary": "This is an archive of the meeting agendas, minutes and reports from the Paediatric Committee (PDCO) from 2012 to 2014.", "categories": "Human", "first_published_date": "03/06/2016", "last_updated_date": "03/06/2016", "general_url": "https://www.ema.europa.eu/en/committees/paediatric-committee-pdco/pdco-meeting-archive-2012-2014" }, { "title": "Marketing authorisation guidance documents", "summary": "This page lists documents and forms applicants may need for the preparation of their marketing authorisation application with the European Medicines Agency (EMA).", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for gadoteric acid - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-gadoteric-acid-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for fluorodopa (18F) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-fluorodopa-18f-scientific-guideline" }, { "title": "Pre-submission request form", "summary": "", "categories": "", "first_published_date": "01/06/2016", "last_updated_date": "01/06/2016", "general_url": "https://www.ema.europa.eu/en/pre-submission-request-form" }, { "title": "ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/05/2016", "last_updated_date": "31/05/2016", "general_url": "https://www.ema.europa.eu/en/ich-s3a-toxicokinetics-assessment-systemic-exposure-toxicity-studies-questions-answers-scientific-guideline" }, { "title": "Plant testing strategy for veterinary medicinal products", "summary": "", "categories": "", "first_published_date": "27/05/2016", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/plant-testing-strategy-veterinary-medicinal-products" }, { "title": "Non-clinical guidelines: pharmacology and safety pharmacology", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "25/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines/non-clinical-guidelines-pharmacology-safety-pharmacology" }, { "title": "Non-clinical guidelines: toxicology", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "25/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines/non-clinical-guidelines-toxicology" }, { "title": "Non-clinical development guidelines", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "25/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines/non-clinical-development-guidelines" }, { "title": "Non-clinical guidelines: pharmacokinetics and toxicokinetics", "summary": "", "categories": "Human", "first_published_date": "26/04/2010", "last_updated_date": "25/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines/non-clinical-guidelines-pharmacokinetics-toxicokinetics" }, { "title": "PRAC: meeting archive 2015-2017", "summary": "This is an archive of the meeting highlights, agendas and minutes from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in 2015 to 2017.", "categories": "Human", "first_published_date": "13/05/2016", "last_updated_date": "13/05/2016", "general_url": "https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac/prac-meeting-archive-2015-2017" }, { "title": "PRAC: meeting archive 2012-2014", "summary": "This is an archive of the meeting highlights, agendas and minutes from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in 2012 to 2014.", "categories": "Human", "first_published_date": "13/05/2016", "last_updated_date": "13/05/2016", "general_url": "https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac/prac-meeting-archive-2012-2014" }, { "title": "Dissolution specification for generic oral immediate release products", "summary": "", "categories": "", "first_published_date": "13/05/2016", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/dissolution-specification-generic-oral-immediate-release-products" }, { "title": "CVMP: meeting archive 2013-2015", "summary": "This is an archive of the meeting highlights and monthly reports from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) in 2013 to 2015.", "categories": "Veterinary", "first_published_date": "12/05/2016", "last_updated_date": "12/05/2016", "general_url": "https://www.ema.europa.eu/en/committees/committee-veterinary-medicinal-products-cvmp/cvmp-meeting-archive-2013-2015" }, { "title": "CHMP: meeting archive 2013-2015", "summary": "This is an archive of the meeting highlights, agendas and minutes from the Committee for Medicinal Products for Human Use (CHMP) in 2013 to 2015.", "categories": "Human", "first_published_date": "12/05/2016", "last_updated_date": "12/05/2016", "general_url": "https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp/chmp-meeting-archive-2013-2015" }, { "title": "Needs for paediatric medicines", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "11/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/paediatric-medicines-research-and-development/needs-paediatric-medicines" }, { "title": "Non-clinical guidelines: environmental risk assessment", "summary": "The European Medicines Agency's scientific guidelines on environmental risk assessment help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "10/05/2016", "last_updated_date": "10/05/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines/non-clinical-guidelines-environmental-risk-assessment" }, { "title": "Pharmacovigilance: Regulatory and procedural guidance", "summary": "The European Medicines Agency developed the good-pharmacovigilance-practice (GVP) guideline to facilitate the performance of pharmacovigilance activities in the European Union. GVP is a key deliverable of the 2010 pharmacovigilance legislation to replace earlier guidance drawn up by the European Commission.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "29/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/pharmacovigilance-regulatory-procedural-guidance" }, { "title": "Standardised units of measurement for veterinary antimicrobials", "summary": "The European Medicines Agency (EMA) has established standardised units of measurement for reporting antimicrobial consumption in specific animal species, called the 'defined daily dose' and 'defined course dose' for animals. This initiative aims to support the harmonisation and standardisation of reporting data on veterinary antimicrobial consumption collected at European level.", "categories": "Veterinary", "first_published_date": "28/04/2016", "last_updated_date": "28/04/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine/european-surveillance-veterinary-antimicrobial-consumption-esvac-2009-2023/standardised-units-measurement-veterinary-antimicrobials" }, { "title": "Clinical efficacy and safety guidelines: cardiovascular system", "summary": "The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used in conditions affecting the cardiovascular system help medicine developers prepare marketing authorisation applications.", "categories": "Human", "first_published_date": "30/03/2010", "last_updated_date": "27/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-cardiovascular-system" }, { "title": "Eudravigilance stakeholders", "summary": "", "categories": "", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "general_url": "https://www.ema.europa.eu/en/eudravigilance-stakeholders" }, { "title": "Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man - the use of patient-reported outcome (PRO) measures in oncology studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/04/2016", "last_updated_date": "22/04/2016", "general_url": "https://www.ema.europa.eu/en/appendix-2-guideline-evaluation-anticancer-medicinal-products-man-use-patient-reported-outcome-pro-measures-oncology-studies-scientific-guideline" }, { "title": "Quality guidelines: manufacturing", "summary": "", "categories": "Human", "first_published_date": "24/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-manufacturing" }, { "title": "Quality guidelines: impurities", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-impurities" }, { "title": "Quality guidelines: excipients", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-excipients" }, { "title": "Quality guidelines: specifications, analytical procedures and analytical validation", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-specifications-analytical-procedures-analytical-validation" }, { "title": "Quality guidelines: active substance", "summary": "", "categories": "Human", "first_published_date": "24/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-active-substance" }, { "title": "Quality guidelines: stability", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-stability" }, { "title": "Quality guidelines: lifecycle management", "summary": "The guidelines on post approval change management protocol and pharmaceutical product lifecycle management help medicine developers prepare marketing authorisation applications for human medicines.", "categories": "Human", "first_published_date": "04/11/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-lifecycle-management" }, { "title": "Quality Working Party questions and answers on API mix - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "21/04/2016", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/quality-working-party-questions-answers-api-mix-scientific-guideline" }, { "title": "Quality guidelines: pharmaceutical development", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-pharmaceutical-development" }, { "title": "Quality guidelines: packaging", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/04/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-guidelines/quality-guidelines-packaging" }, { "title": "Quality: availability (minor uses/minor species)", "summary": "", "categories": "", "first_published_date": "15/04/2016", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/quality-availability-minor-uses-minor-species" }, { "title": "Quality: post approval change management protocols", "summary": "", "categories": "", "first_published_date": "15/04/2016", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/quality-post-approval-change-management-protocols" }, { "title": "Guidance for applicants seeking scientific support and advice on traditional herbal medicinal products", "summary": "", "categories": "", "first_published_date": "11/04/2016", "last_updated_date": "11/04/2016", "general_url": "https://www.ema.europa.eu/en/guidance-applicants-seeking-scientific-support-advice-traditional-herbal-medicinal-products" }, { "title": "HMPC status report", "summary": "", "categories": "Herbal", "first_published_date": "04/04/2016", "last_updated_date": "04/04/2016", "general_url": "https://www.ema.europa.eu/en/hmpc-status-report" }, { "title": "Action plan for herbal medicines 2010-2011", "summary": "", "categories": "", "first_published_date": "04/04/2016", "last_updated_date": "04/04/2016", "general_url": "https://www.ema.europa.eu/en/action-plan-herbal-medicines-2010-2011" }, { "title": "ICH guidelines: considerations", "summary": "", "categories": "Human", "first_published_date": "30/03/2016", "last_updated_date": "30/03/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines/ich-guidelines-considerations" }, { "title": "Guideline on the documentation to be submitted for inclusion into the 'community list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products'", "summary": "", "categories": "", "first_published_date": "21/03/2016", "last_updated_date": "21/03/2016", "general_url": "https://www.ema.europa.eu/en/guideline-documentation-be-submitted-inclusion-community-list-herbal-substances-preparations-combinations-thereof-use-traditional-herbal-medicinal-products" }, { "title": "Template for a public statement when no European Union herbal monograph is established", "summary": "", "categories": "Herbal", "first_published_date": "21/03/2016", "last_updated_date": "21/03/2016", "general_url": "https://www.ema.europa.eu/en/template-public-statement-when-no-european-union-herbal-monograph-established" }, { "title": "Herbal medicines: regulatory and scientific support", "summary": "Companies seeking market access for traditional herbal medicines in European Union (EU) Member States need to follow national procedures. However, applicants can request scientific support and advice from the Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency (EMA). National competent authorities of Member States can consult the HMPC on scientific and regulatory aspects of applications.", "categories": "Herbal", "first_published_date": "20/03/2016", "last_updated_date": "20/03/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/herbal-medicines-regulatory-scientific-support" }, { "title": "Template for submission by Committee on Herbal Medicinal Products (HMPC) members or national competent authorities of questions for discussion by the HMPC", "summary": "", "categories": "Human;Herbal", "first_published_date": "15/03/2016", "last_updated_date": "15/03/2016", "general_url": "https://www.ema.europa.eu/en/template-submission-committee-herbal-medicinal-products-hmpc-members-or-national-competent-authorities-questions-discussion-hmpc" }, { "title": "Template for submission of a request for scientific support and advice on a traditional herbal medicinal product", "summary": "", "categories": "Human;Herbal", "first_published_date": "15/03/2016", "last_updated_date": "15/03/2016", "general_url": "https://www.ema.europa.eu/en/template-submission-request-scientific-support-advice-traditional-herbal-medicinal-product" }, { "title": "Clinical efficacy and safety: biostatistics", "summary": "", "categories": "", "first_published_date": "14/03/2016", "last_updated_date": "14/03/2016", "general_url": "https://www.ema.europa.eu/en/clinical-efficacy-safety-biostatistics" }, { "title": "Core summary of product characteristics and package leaflet for gadopentetate dimeglumine - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/03/2016", "last_updated_date": "14/03/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-package-leaflet-gadopentetate-dimeglumine-scientific-guideline" }, { "title": "Template and recommended format for list of references", "summary": "", "categories": "", "first_published_date": "11/03/2016", "last_updated_date": "11/03/2016", "general_url": "https://www.ema.europa.eu/en/template-recommended-format-list-references" }, { "title": "Template for a European Union list entry", "summary": "", "categories": "Herbal", "first_published_date": "11/03/2016", "last_updated_date": "11/03/2016", "general_url": "https://www.ema.europa.eu/en/template-european-union-list-entry" }, { "title": "Procedure on the publication of Committee on Herbal Medicinal Products public statements when European Union herbal monographs on herbal substances, preparations and/or combinations thereof are not established", "summary": "", "categories": "Herbal", "first_published_date": "11/03/2016", "last_updated_date": "11/03/2016", "general_url": "https://www.ema.europa.eu/en/procedure-publication-committee-herbal-medicinal-products-public-statements-when-european-union-herbal-monographs-herbal-substances-preparations-or-combinations-thereof-are-not-established" }, { "title": "Reflection paper on the reasons and timelines for revision of final European Union herbal monographs and list entries", "summary": "", "categories": "", "first_published_date": "11/03/2016", "last_updated_date": "11/03/2016", "general_url": "https://www.ema.europa.eu/en/reflection-paper-reasons-timelines-revision-final-european-union-herbal-monographs-list-entries" }, { "title": "Limitations to the use of ethylene oxide in the manufacture of medicinal products (human) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/03/2016", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/limitations-use-ethylene-oxide-manufacture-medicinal-products-human-scientific-guideline" }, { "title": "European Union monographs and list entries", "summary": "The Committee on Herbal Medicinal Products (HMPC) compiles and assesses scientific data on herbal substances, preparations and combinations with a focus on safety and efficacy. This work supports the harmonisation of the European market: national competent authorities are able to refer to one unique set of information on a herbal substance or preparation when evaluating marketing applications.", "categories": "", "first_published_date": "10/03/2016", "last_updated_date": "10/03/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products/european-union-monographs-list-entries" }, { "title": "Clinical efficacy and safety guidelines: nervous system", "summary": "", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "04/03/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-nervous-system" }, { "title": "Annual bulletins on veterinary pharmacovigilance activities (2003-19)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "26/02/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/annual-bulletins-veterinary-pharmacovigilance-activities-2003-19" }, { "title": "VICH GL55 Harmonisation of criteria to waive target animal batch safety testing for live vaccines for veterinary use - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/02/2016", "last_updated_date": "26/02/2016", "general_url": "https://www.ema.europa.eu/en/vich-gl55-harmonisation-criteria-waive-target-animal-batch-safety-testing-live-vaccines-veterinary-use-scientific-guideline" }, { "title": "Clinical efficacy and safety: haematology and blood products (including biotech alternatives) guidelines", "summary": "", "categories": "Human", "first_published_date": "30/03/2010", "last_updated_date": "11/02/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-haematology-blood-products-including-biotech-alternatives-guidelines" }, { "title": "Clinical efficacy and safety guidelines: Alimentary tract and metabolism", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "11/02/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-alimentary-tract-metabolism" }, { "title": "Herbal medicinal products: scientific guidelines", "summary": "", "categories": "Herbal", "first_published_date": "09/02/2016", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/herbal-medicinal-products-scientific-guidelines" }, { "title": "Support for early access", "summary": "The European Medicines Agency (EMA) is committed to enabling early patient access to new medicines, particularly those that target an unmet medical need or are of major public health interest.", "categories": "Human", "first_published_date": "09/02/2016", "last_updated_date": "09/02/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/support-early-access" }, { "title": "Safety guidelines: veterinary limited markets", "summary": "", "categories": "Veterinary", "first_published_date": "27/04/2010", "last_updated_date": "04/02/2016", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines/safety-guidelines-veterinary-limited-markets" }, { "title": "Assessment of the effect of antimicrobial substances on dairy starter cultures - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2016", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/assessment-effect-antimicrobial-substances-dairy-starter-cultures-scientific-guideline" }, { "title": "Reporting requirements for marketing-authorisation holders", "summary": "", "categories": "", "first_published_date": "31/01/2014", "last_updated_date": "22/01/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/reporting-requirements-marketing-authorisation-holders" }, { "title": "Pharmacovigilance system: questions and answers", "summary": "This page lists questions that marketing-authorisation holders (MAHs) may have on the pharmacovigilance system.", "categories": "Human", "first_published_date": "26/03/2013", "last_updated_date": "20/01/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/pharmacovigilance-system-questions-answers" }, { "title": "VICH GL49 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: validation of analytical methods used in residue depletion studies - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "27/02/2015", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/vich-gl49-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-animals-validation-analytical-methods-used-residue-depletion-studies-scientific-guideline" }, { "title": "Core summary of product characteristics for plasma-derived fibrin sealant/haemostatic products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/06/2015", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-plasma-derived-fibrin-sealant-haemostatic-products-scientific-guideline" }, { "title": "Notifications: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/notifications-regulatory-procedural-guidance" }, { "title": "Type II variations: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ii-variations-questions-answers/type-ii-variations-regulatory-procedural-guidance" }, { "title": "Type II Variations vs Extension applications: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/type-ii-variations-vs-extension-applications-regulatory-procedural-guidance" }, { "title": "Transfer of MA: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "01/01/2016", "last_updated_date": "01/01/2016", "general_url": "https://www.ema.europa.eu/en/transfer-ma-regulatory-procedural-guidance" }, { "title": "Good laboratory practice compliance", "summary": "The principles of Good Laboratory Practice (GLP) define a set of rules and criteria for a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, reported and archived.", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "21/12/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-laboratory-practice-compliance" }, { "title": "Clinical efficacy and safety guidelines: general", "summary": "", "categories": "Human", "first_published_date": "25/03/2010", "last_updated_date": "21/12/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-general" }, { "title": "Chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/12/2015", "last_updated_date": "19/12/2015", "general_url": "https://www.ema.europa.eu/en/chemical-structure-properties-criteria-be-considered-evaluation-new-active-substance-nas-status-chemical-substances-scientific-guideline" }, { "title": "Guidance on statistical principles for clinical trials for immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/12/2015", "last_updated_date": "18/12/2015", "general_url": "https://www.ema.europa.eu/en/guidance-statistical-principles-clinical-trials-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of asthma - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/12/2015", "last_updated_date": "15/12/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-asthma-scientific-guideline" }, { "title": "Governance and reporting", "summary": "Effective governance and accountability structures are vital for the European Medicines Agency (EMA) to continually review and strengthen the quality of its services. In line with legal requirements and EMA's guiding principle of transparency, EMA makes publicly available information and documentation on its legal remit, working structures, financial accounts and budget and corporate governance", "categories": "Corporate", "first_published_date": "07/12/2015", "last_updated_date": "07/12/2015", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting" }, { "title": "Medication errors", "summary": "", "categories": "", "first_published_date": "01/03/2013", "last_updated_date": "27/11/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medication-errors" }, { "title": "Non-clinical local tolerance testing of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/11/2015", "last_updated_date": "27/11/2015", "general_url": "https://www.ema.europa.eu/en/non-clinical-local-tolerance-testing-medicinal-products-scientific-guideline" }, { "title": "Standard paediatric investigation plans", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "23/11/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/paediatric-investigation-plans/standard-paediatric-investigation-plans" }, { "title": "Clinical efficacy and safety guidelines: rheumatology and musculoskeletal system", "summary": "", "categories": "Human", "first_published_date": "31/03/2010", "last_updated_date": "20/11/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-rheumatology-musculoskeletal-system" }, { "title": "Key aspects for the use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/11/2015", "last_updated_date": "20/11/2015", "general_url": "https://www.ema.europa.eu/en/key-aspects-use-pharmacogenomic-methodologies-pharmacovigilance-evaluation-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/11/2015", "last_updated_date": "20/11/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-juvenile-idiopathic-arthritis-scientific-guideline" }, { "title": "Guidelines relevant for advanced therapy medicinal products", "summary": "The European Medicines Agency develops scientific guidelines to help pharmaceutical companies and individuals to prepare marketing-authorisation applications for human medicines. This page lists relevant guidelines for applicants for advanced therapy medicinal products.", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "09/10/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/guidelines-relevant-advanced-therapy-medicinal-products" }, { "title": "Meetings with stakeholders and other organisations", "summary": "The Committee for Advanced Therapies (CAT) engages in active dialogue with its stakeholders in the field of advanced therapies, including industry, developers of medicines, academia, patients and clinicians.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "09/10/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/meetings-stakeholders-other-organisations" }, { "title": "Legal framework: Advanced therapies", "summary": "The regulatory framework for advanced therapy medicinal products (ATMPs) is designed to ensure the free movement of these medicines within the European Union (EU), to facilitate their access to the EU market, and to foster the competitiveness of European pharmaceutical companies in the field, while guaranteeing the highest level of health protection for patients.", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "09/10/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/advanced-therapy-medicinal-products-overview/legal-framework-advanced-therapies" }, { "title": "Paediatric medicines procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "09/10/2015", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures/paediatric-medicines-procedures" }, { "title": "Clinical efficacy and safety: antineoplastic and immunomodulating agent guidelines", "summary": "", "categories": "Human", "first_published_date": "31/03/2010", "last_updated_date": "07/10/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-antineoplastic-immunomodulating-agent-guidelines" }, { "title": "Use of heat treatment to inactivate endogenous retroviruses in live immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2015", "last_updated_date": "17/09/2015", "general_url": "https://www.ema.europa.eu/en/use-heat-treatment-inactivate-endogenous-retroviruses-live-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Assessment of persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances in veterinary medicinal products", "summary": "", "categories": "", "first_published_date": "17/09/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/assessment-persistent-bioaccumulative-toxic-pbt-or-very-persistent-very-bioaccumulative-vpvb-substances-veterinary-medicinal-products" }, { "title": "Replacement of cell lines used for the production of immunological veterinary medicinal products (IVMPs) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/09/2015", "last_updated_date": "17/09/2015", "general_url": "https://www.ema.europa.eu/en/replacement-cell-lines-used-production-immunological-veterinary-medicinal-products-ivmps-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of chronic constipation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/09/2015", "last_updated_date": "14/09/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-chronic-constipation-scientific-guideline" }, { "title": "European Risk Management Strategy (ERMS)", "summary": "", "categories": "Human", "first_published_date": "19/06/2010", "last_updated_date": "28/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/european-risk-management-strategy-erms" }, { "title": "Stakeholder meetings: pharmacovigilance legislation", "summary": "", "categories": "Human", "first_published_date": "02/02/2012", "last_updated_date": "28/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-framework-pharmacovigilance/stakeholder-meetings-pharmacovigilance-legislation" }, { "title": "Paediatric formulations", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/paediatric-medicines-research-and-development/paediatric-investigation-plans/paediatric-formulations" }, { "title": "Paediatric requirements for marketing-authorisation applications", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/paediatric-medicines-marketing-authorisation/paediatric-requirements-marketing-authorisation-applications" }, { "title": "Paediatric requirements for variations and extensions to marketing authorisations", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/paediatric-requirements-variations-extensions-marketing-authorisations" }, { "title": "Paediatric medicines: Post-authorisation", "summary": "This section provides information on the European Medicines Agency's activities relating to paediatric medicines during the post-authorisation stage.", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation" }, { "title": "Deadlines for placing paediatric medicines on the market", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/deadlines-placing-paediatric-medicines-market" }, { "title": "Funding for paediatric studies", "summary": "", "categories": "Human", "first_published_date": "10/08/2015", "last_updated_date": "10/08/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development/funding-paediatric-studies" }, { "title": "Core summary of product characteristics for human fibrinogen products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-fibrinogen-products-scientific-guideline" }, { "title": "Clinical investigation of hepatitis B immunoglobulins - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2015", "last_updated_date": "24/07/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-hepatitis-b-immunoglobulins-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for sodium fluoride (18F) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/07/2015", "last_updated_date": "20/07/2015", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-sodium-fluoride-18f-scientific-guideline" }, { "title": "Sunitinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/07/2015", "last_updated_date": "07/07/2015", "general_url": "https://www.ema.europa.eu/en/sunitinib-product-specific-bioequivalence-guidance" }, { "title": "Capecitabine product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/07/2015", "last_updated_date": "07/07/2015", "general_url": "https://www.ema.europa.eu/en/capecitabine-product-specific-bioequivalence-guidance" }, { "title": "Viral safety of plasma-derived medicinal products with respect to hepatitis E virus - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2015", "last_updated_date": "01/07/2015", "general_url": "https://www.ema.europa.eu/en/viral-safety-plasma-derived-medicinal-products-respect-hepatitis-e-virus-scientific-guideline" }, { "title": "Use of cocrystals of active substances in medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "16/06/2015", "last_updated_date": "16/06/2015", "general_url": "https://www.ema.europa.eu/en/use-cocrystals-active-substances-medicinal-products-scientific-guideline" }, { "title": "Management Board: Meetings 2018", "summary": "", "categories": "", "first_published_date": "16/06/2015", "last_updated_date": "16/06/2015", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2018" }, { "title": "Management Board: Meetings 2017", "summary": "", "categories": "", "first_published_date": "16/06/2015", "last_updated_date": "16/06/2015", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2017" }, { "title": "Assessment of cardiovascular safety profile of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/06/2015", "last_updated_date": "12/06/2015", "general_url": "https://www.ema.europa.eu/en/assessment-cardiovascular-safety-profile-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of acute heart failure - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/06/2015", "last_updated_date": "10/06/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-acute-heart-failure-scientific-guideline" }, { "title": "Telithromycin product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "07/06/2015", "last_updated_date": "07/06/2015", "general_url": "https://www.ema.europa.eu/en/telithromycin-product-specific-bioequivalence-guidance" }, { "title": "Microbiological aspects of herbal medicinal products and traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "05/06/2015", "last_updated_date": "05/06/2015", "general_url": "https://www.ema.europa.eu/en/microbiological-aspects-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Adventitious agent safety of urine-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/05/2015", "last_updated_date": "29/05/2015", "general_url": "https://www.ema.europa.eu/en/adventitious-agent-safety-urine-derived-medicinal-products-scientific-guideline" }, { "title": "Removal of the target animal batch safetytest (TABST) from European Pharmacopoeia monographs - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/05/2015", "last_updated_date": "18/05/2015", "general_url": "https://www.ema.europa.eu/en/removal-target-animal-batch-safetytest-tabst-european-pharmacopoeia-monographs-scientific-guideline" }, { "title": "20th anniversary conference highlights", "summary": "The European Medicines Agency (EMA) marked its 20th anniversary on 18 March 2015 with a scientific conference entitled 'Science, Medicines, Health: Patients at the heart of future innovation'.", "categories": "Corporate", "first_published_date": "16/04/2015", "last_updated_date": "16/04/2015", "general_url": "https://www.ema.europa.eu/en/about-us/history-ema/20th-anniversary-conference-highlights" }, { "title": "Imatinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "10/04/2015", "general_url": "https://www.ema.europa.eu/en/imatinib-product-specific-bioequivalence-guidance" }, { "title": "Carglumic acid product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "10/04/2015", "general_url": "https://www.ema.europa.eu/en/carglumic-acid-product-specific-bioequivalence-guidance" }, { "title": "Erlotinib product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "10/04/2015", "general_url": "https://www.ema.europa.eu/en/erlotinib-product-specific-bioequivalence-guidance" }, { "title": "Miglustat product-specific bioequivalence guidance", "summary": "", "categories": "Human", "first_published_date": "10/04/2015", "last_updated_date": "10/04/2015", "general_url": "https://www.ema.europa.eu/en/miglustat-product-specific-bioequivalence-guidance" }, { "title": "Questions and answers on quality of herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "10/11/2010", "last_updated_date": "07/04/2015", "general_url": "https://www.ema.europa.eu/en/questions-answers-quality-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of multiple sclerosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/03/2015", "last_updated_date": "31/03/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-multiple-sclerosis-scientific-guideline" }, { "title": "Adjustment for baseline covariates in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "general_url": "https://www.ema.europa.eu/en/adjustment-baseline-covariates-clinical-trials-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of systemic lupus erythematosus and lupus nephritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-systemic-lupus-erythematosus-lupus-nephritis-scientific-guideline" }, { "title": "Data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "27/03/2015", "last_updated_date": "27/03/2015", "general_url": "https://www.ema.europa.eu/en/data-requirements-intravenous-iron-based-nano-colloidal-products-developed-reference-innovator-medicinal-product-scientific-guideline" }, { "title": "Paediatric addendum to the guideline on clinical investigation on medicinal products in the treatment of hypertension - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/03/2015", "last_updated_date": "26/03/2015", "general_url": "https://www.ema.europa.eu/en/paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-hypertension-scientific-guideline" }, { "title": "Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish an acute reference dose (ARfD)", "summary": "", "categories": "", "first_published_date": "20/03/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/studies-evaluate-safety-residues-veterinary-drugs-human-food-general-approach-establish-acute-reference-dose-arfd" }, { "title": "Non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/03/2015", "last_updated_date": "11/03/2015", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-development-similar-biological-medicinal-products-containing-recombinant-human-insulin-insulin-analogues-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for (99Mo/99mTc) generator - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/03/2015", "last_updated_date": "06/03/2015", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-99mo-99mtc-generator-scientific-guideline" }, { "title": "ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/03/2015", "last_updated_date": "03/03/2015", "general_url": "https://www.ema.europa.eu/en/ich-m8-electronic-common-technical-document-ectd-v40-draft-ich-implementation-guide-v20-scientific-guideline" }, { "title": "VICH GL48 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker-residue-depletion studies to establish product withdrawal periods - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "27/02/2015", "last_updated_date": "27/02/2015", "general_url": "https://www.ema.europa.eu/en/vich-gl48-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-animals-marker-residue-depletion-studies-establish-product-withdrawal-periods-scientific-guideline" }, { "title": "Pharmacokinetic studies in man - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2015", "last_updated_date": "01/02/2015", "general_url": "https://www.ema.europa.eu/en/pharmacokinetic-studies-man-scientific-guideline" }, { "title": "Clinical investigation of corticosteroids intended for use on the skin - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2015", "last_updated_date": "01/02/2015", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-corticosteroids-intended-use-skin-scientific-guideline" }, { "title": "Medicinal products (non-steroidal anti-inflammatory compounds) for the treatment of chronic disorders - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2015", "last_updated_date": "01/02/2015", "general_url": "https://www.ema.europa.eu/en/medicinal-products-non-steroidal-anti-inflammatory-compounds-treatment-chronic-disorders-scientific-guideline" }, { "title": "Risk of antimicrobial resistance transfer from companion animals - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/01/2015", "last_updated_date": "30/01/2015", "general_url": "https://www.ema.europa.eu/en/risk-antimicrobial-resistance-transfer-companion-animals-scientific-guideline" }, { "title": "Risk characterisation and assessment of maximum residue limits (MRL) for biocides - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/01/2015", "last_updated_date": "30/01/2015", "general_url": "https://www.ema.europa.eu/en/risk-characterisation-assessment-maximum-residue-limits-mrl-biocides-scientific-guideline" }, { "title": "ICH M2 Electronic common technical document (eCTD) - file format criteria - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/01/2015", "last_updated_date": "12/01/2015", "general_url": "https://www.ema.europa.eu/en/ich-m2-electronic-common-technical-document-ectd-file-format-criteria-scientific-guideline" }, { "title": "Similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/01/2015", "last_updated_date": "09/01/2015", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-clinical-issues-scientific-guideline" }, { "title": "Need for a guideline on process validation of medicinal products containing biotechnology derived proteins as active substance", "summary": "", "categories": "", "first_published_date": "06/06/2011", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/need-guideline-process-validation-medicinal-products-containing-biotechnology-derived-proteins-active-substance" }, { "title": "All herbal documents under consultation", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/all-herbal-documents-under-consultation" }, { "title": "Comparability of medicinal products containing biotechnology-derived proteins as active substance (Annex on non-clinical and clinical issues)", "summary": "", "categories": "", "first_published_date": "17/12/2003", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/comparability-medicinal-products-containing-biotechnology-derived-proteins-active-substance-annex-non-clinical-clinical-issues" }, { "title": "Potency testing of cell based immunotherapy medicinal products for the treatment of cancer", "summary": "", "categories": "", "first_published_date": "17/09/2009", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/potency-testing-cell-based-immunotherapy-medicinal-products-treatment-cancer" }, { "title": "EudraVigilance Gateway", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/eudravigilance-gateway" }, { "title": "Submitting a post-authorisation application", "summary": "", "categories": "Human", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/submitting-post-authorisation-application" }, { "title": "Assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/02/2001", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/assessment-risk-transmission-animal-spongiform-encephalopathy-agents-master-seed-materials-used-production-veterinary-vaccines-scientific-guideline" }, { "title": "All herbal community lists", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/all-herbal-community-lists" }, { "title": "Evaluation of bovine spongiform encephalopathies (BSE)-risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2001", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/evaluation-bovine-spongiform-encephalopathies-bse-risk-use-materials-bovine-origin-or-during-manufacture-vaccines-scientific-guideline" }, { "title": "Stolen vials of medicine in Italy", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/stolen-vials-medicine-italy" }, { "title": "title>", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/title" }, { "title": "e-Reporting", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/e-reporting" }, { "title": "Chemistry of active substances", "summary": "", "categories": "", "first_published_date": "01/10/1997", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/chemistry-active-substances" }, { "title": "PRAC: Committee agendas, minutes and meeting highlights report archive 2012-2013", "summary": "", "categories": "", "first_published_date": "01/01/2015", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/prac-committee-agendas-minutes-meeting-highlights-report-archive-2012-2013" }, { "title": "Requirements for concurrent administration of immunological veterinary medicinal products", "summary": "", "categories": "", "first_published_date": "01/10/2003", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/requirements-concurrent-administration-immunological-veterinary-medicinal-products" }, { "title": "Chemistry of new active substances", "summary": "", "categories": "", "first_published_date": "17/12/2003", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/chemistry-new-active-substances" }, { "title": "Stability testing: requirements for new dosage forms (ICH Q1C)", "summary": "", "categories": "", "first_published_date": "01/12/1996", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/stability-testing-requirements-new-dosage-forms-ich-q1c" }, { "title": "Herceptin, Alimta and Remicade batches concerned by ongoing investigation", "summary": "", "categories": "", "first_published_date": "24/04/2014", "last_updated_date": "01/01/2015", "general_url": "https://www.ema.europa.eu/en/herceptin-alimta-remicade-batches-concerned-ongoing-investigation" }, { "title": "Quality of transdermal patches - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/12/2014", "last_updated_date": "16/12/2014", "general_url": "https://www.ema.europa.eu/en/quality-transdermal-patches-scientific-guideline" }, { "title": "Use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/12/2014", "last_updated_date": "15/12/2014", "general_url": "https://www.ema.europa.eu/en/use-minimal-residue-disease-endpoint-chronic-lymphocytic-leukaemia-studies-scientific-guideline" }, { "title": "Clinical aspects related to tissue engineered products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/12/2014", "last_updated_date": "11/12/2014", "general_url": "https://www.ema.europa.eu/en/clinical-aspects-related-tissue-engineered-products-scientific-guideline" }, { "title": "Use of phthalates as excipients in human medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/11/2014", "last_updated_date": "24/11/2014", "general_url": "https://www.ema.europa.eu/en/use-phthalates-excipients-human-medicinal-products-scientific-guideline" }, { "title": "Compliance of authorised equine influenza vaccines with OIE requirements - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/11/2014", "last_updated_date": "19/11/2014", "general_url": "https://www.ema.europa.eu/en/compliance-authorised-equine-influenza-vaccines-oie-requirements-scientific-guideline" }, { "title": "Data requirements for changes to the strain composition of authorised equine influenza vaccines in line with OIE recommendations - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/11/2014", "last_updated_date": "19/11/2014", "general_url": "https://www.ema.europa.eu/en/data-requirements-changes-strain-composition-authorised-equine-influenza-vaccines-line-oie-recommendations-scientific-guideline" }, { "title": "Evaluation of medicinal products for the treatment of irritable bowel syndrome - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/09/2014", "last_updated_date": "25/09/2014", "general_url": "https://www.ema.europa.eu/en/evaluation-medicinal-products-treatment-irritable-bowel-syndrome-scientific-guideline" }, { "title": "Quality of oral modified release products - Scientific guidelines", "summary": "", "categories": "Human", "first_published_date": "31/07/2014", "last_updated_date": "31/07/2014", "general_url": "https://www.ema.europa.eu/en/quality-oral-modified-release-products-scientific-guidelines" }, { "title": "Transferring quality control methods validated in collaborative trials to a product/laboratory specific context - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/07/2014", "last_updated_date": "18/07/2014", "general_url": "https://www.ema.europa.eu/en/transferring-quality-control-methods-validated-collaborative-trials-product-laboratory-specific-context-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for prevention of stroke and systemic embolic events in patients with non-valvular atrial fibrillation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/07/2014", "last_updated_date": "16/07/2014", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-prevention-stroke-systemic-embolic-events-patients-non-valvular-atrial-fibrillation-scientific-guideline" }, { "title": "ICH M5 Data elements and standards for drug dictionaries - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/07/2014", "last_updated_date": "14/07/2014", "general_url": "https://www.ema.europa.eu/en/ich-m5-data-elements-standards-drug-dictionaries-scientific-guideline" }, { "title": "Clinical investigation of medicinal products to prevent development/slow progression of chronic renal insufficiency - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2014", "last_updated_date": "01/07/2014", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-prevent-development-slow-progression-chronic-renal-insufficiency-scientific-guideline" }, { "title": "Benzalkonium chloride - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/06/2014", "last_updated_date": "30/06/2014", "general_url": "https://www.ema.europa.eu/en/benzalkonium-chloride-scientific-guideline" }, { "title": "Pharmacovigilance inspections for veterinary medicines", "summary": "The European Medicines Agency (EMA) has developed procedures for the coordination, conduct and reporting of pharmacovigilance inspections carried out in the context of the centralised procedure for veterinary medicines.", "categories": "Veterinary", "first_published_date": "20/06/2014", "last_updated_date": "10/01/2014", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/compliance-marketing-authorisation/pharmacovigilance-inspections-veterinary-medicines" }, { "title": "Management Board: Meetings 2016", "summary": "", "categories": "", "first_published_date": "19/06/2014", "last_updated_date": "19/06/2014", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2016" }, { "title": "Management Board: Meetings 2015", "summary": "", "categories": "", "first_published_date": "19/06/2014", "last_updated_date": "19/06/2014", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2015" }, { "title": "Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/06/2014", "last_updated_date": "03/06/2014", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues-scientific-guideline" }, { "title": "Gaucher disease: a strategic collaborative approach from the European Medicines Agency and Food and Drug Administration - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/05/2014", "last_updated_date": "14/05/2014", "general_url": "https://www.ema.europa.eu/en/gaucher-disease-strategic-collaborative-approach-european-medicines-agency-food-drug-administration-scientific-guideline" }, { "title": "Quality of essential oils as active substances in herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "02/05/2014", "last_updated_date": "02/05/2014", "general_url": "https://www.ema.europa.eu/en/quality-essential-oils-active-substances-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/04/2014", "last_updated_date": "30/04/2014", "general_url": "https://www.ema.europa.eu/en/process-validation-manufacture-biotechnology-derived-active-substances-data-be-provided-regulatory-submission-scientific-guideline" }, { "title": "Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/03/2014", "last_updated_date": "28/03/2014", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-intended-treatment-chronic-primary-immune-thrombocytopenia-scientific-guideline" }, { "title": "Declaration of the quantitative composition/potency labelling of biological medicinalproducts that contain modified proteins as active substance - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/03/2014", "last_updated_date": "21/03/2014", "general_url": "https://www.ema.europa.eu/en/declaration-quantitative-composition-potency-labelling-biological-medicinalproducts-contain-modified-proteins-active-substance-scientific-guideline" }, { "title": "Management Board: Meetings 2014", "summary": "", "categories": "", "first_published_date": "14/03/2014", "last_updated_date": "14/03/2014", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2014" }, { "title": "Use of porcine trypsin used in the manufacture of human biological medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2014", "last_updated_date": "28/02/2014", "general_url": "https://www.ema.europa.eu/en/use-porcine-trypsin-used-manufacture-human-biological-medicinal-products-scientific-guideline" }, { "title": "Process validation for finished products – information and data to be provided in regulatory submissions - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "28/02/2014", "last_updated_date": "28/02/2014", "general_url": "https://www.ema.europa.eu/en/process-validation-finished-products-information-data-be-provided-regulatory-submissions-scientific-guideline" }, { "title": "Use of pleuromutilins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/02/2014", "last_updated_date": "20/02/2014", "general_url": "https://www.ema.europa.eu/en/use-pleuromutilins-food-producing-animals-european-union-development-resistance-impact-human-animal-health-scientific-guideline" }, { "title": "Registration", "summary": "", "categories": "Human", "first_published_date": "05/03/2012", "last_updated_date": "31/01/2014", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/registration" }, { "title": "ICH Q4B Annex 6 Uniformity of dosage unites general chapter - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/01/2014", "last_updated_date": "31/01/2014", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-6-uniformity-dosage-unites-general-chapter-scientific-guideline" }, { "title": "ICH S10 Photosafety evaluation of pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/01/2014", "last_updated_date": "31/01/2014", "general_url": "https://www.ema.europa.eu/en/ich-s10-photosafety-evaluation-pharmaceuticals-scientific-guideline" }, { "title": "Development of block-copolymer-micelle medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "10/01/2014", "last_updated_date": "10/01/2014", "general_url": "https://www.ema.europa.eu/en/development-block-copolymer-micelle-medicinal-products-scientific-guideline" }, { "title": "CAT: meeting archive 2009-2012", "summary": "", "categories": "Human", "first_published_date": "18/09/2013", "last_updated_date": "17/12/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat/cat-meeting-archive-2009-2012" }, { "title": "CHMP: meeting archive 2010-2012", "summary": "This is an archive of the meeting highlights and monthly reports from the Committee for Medicinal Products for Human Use (CHMP) in 2010 to 2012.", "categories": "Human", "first_published_date": "01/01/2010", "last_updated_date": "17/12/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp/chmp-meeting-archive-2010-2012" }, { "title": "CVMP: meeting archive 2005-2012", "summary": "This is an archive of the monthly reports from the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) for the years 2005 to 2012.", "categories": "Veterinary", "first_published_date": "18/09/2013", "last_updated_date": "17/12/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-veterinary-medicinal-products-cvmp/cvmp-meeting-archive-2005-2012" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for technetium (99mTc) sestamibi - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/2013", "last_updated_date": "17/12/2013", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-technetium-99mtc-sestamibi-scientific-guideline" }, { "title": "Use of recovered/recycled solvents in the manufacture of herbal preparations for use in herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "03/12/2013", "last_updated_date": "03/12/2013", "general_url": "https://www.ema.europa.eu/en/use-recovered-recycled-solvents-manufacture-herbal-preparations-use-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Combined hormonal contraceptives", "summary": "", "categories": "Human", "first_published_date": "12/07/2013", "last_updated_date": "22/11/2013", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/referral-procedures-human-medicines/combined-hormonal-contraceptives" }, { "title": "CHMP: meeting archive 2001-2009", "summary": "This is an archive of the monthly meeting reports from the Committee for Medicinal Products for Human Use (CHMP) in 2001 to 2009.", "categories": "Human", "first_published_date": "31/01/2011", "last_updated_date": "18/11/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp/chmp-meeting-archive-2001-2009" }, { "title": "Routes of administration of vaccines to poultry - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/11/2013", "last_updated_date": "18/11/2013", "general_url": "https://www.ema.europa.eu/en/routes-administration-vaccines-poultry-scientific-guideline" }, { "title": "Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh)", "summary": "The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) was set up in 2005. It replaced the informal Mutual Recognition Facilitation Group.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "06/11/2013", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/coordination-group-mutual-recognition-decentralised-procedures-human-cmdh" }, { "title": "Quality by design: questions and answers", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "04/11/2013", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/quality-design/quality-design-questions-answers" }, { "title": "Legal framework", "summary": "The European Union (EU) legal framework for pharmaceuticals is aimed at ensuring a high level of protection of public health. It is based on the principle that the placing of a medicine on the market is subject to the granting of a marketing authorisation by the competent authorities.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "22/10/2013", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/legal-framework" }, { "title": "Injection-site residues: considerations for risk assessment and residue surveillance - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/10/2013", "last_updated_date": "18/10/2013", "general_url": "https://www.ema.europa.eu/en/injection-site-residues-considerations-risk-assessment-residue-surveillance-scientific-guideline" }, { "title": "Additional monitoring - information materials", "summary": "", "categories": "Human", "first_published_date": "01/10/2013", "last_updated_date": "26/09/2013", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/medicines-under-additional-monitoring/additional-monitoring-information-materials" }, { "title": "COMP: meeting archive 2007-2011", "summary": "This is an archive of the meeting reports from the Committee for Orphan Medicinal Products (COMP) plenary meetings from 2007 to 2011.", "categories": "Human", "first_published_date": "16/09/2013", "last_updated_date": "16/09/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-orphan-medicinal-products-comp/comp-meeting-archive-2007-2011" }, { "title": "PDCO: Committee meeting report archive 2007-2011", "summary": "This is an archive of the meeting reports from the European Medicines Agency's Paediatric Committee (PDCO) for the years 2007 to 2011.", "categories": "", "first_published_date": "16/09/2013", "last_updated_date": "16/09/2013", "general_url": "https://www.ema.europa.eu/en/committees/paediatric-committee-pdco/pdco-committee-meeting-report-archive-2007-2011" }, { "title": "HMPC: meeting archive 2004-2011", "summary": "This is an archive of the meeting reports from the European Medicines Agency's Committee on Herbal Medicinal Products (HMPC) from 2004 to 2011.", "categories": "Human;Herbal", "first_published_date": "16/09/2013", "last_updated_date": "16/09/2013", "general_url": "https://www.ema.europa.eu/en/committees/committee-herbal-medicinal-products-hmpc/hmpc-meeting-archive-2004-2011" }, { "title": "ICH Q4B Annex 12 Analytical sieving - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/09/2013", "last_updated_date": "01/09/2013", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-12-analytical-sieving-scientific-guideline" }, { "title": "Surface coatings: general issues for consideration regarding parenteral administration of coated nanomedicine products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "15/08/2013", "last_updated_date": "15/08/2013", "general_url": "https://www.ema.europa.eu/en/surface-coatings-general-issues-consideration-regarding-parenteral-administration-coated-nanomedicine-products-scientific-guideline" }, { "title": "Management of clinical risks deriving from insertional mutagenesis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/08/2013", "last_updated_date": "01/08/2013", "general_url": "https://www.ema.europa.eu/en/management-clinical-risks-deriving-insertional-mutagenesis-scientific-guideline" }, { "title": "Pharmaceutical development of medicines for paediatric use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/07/2013", "last_updated_date": "31/07/2013", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-development-medicines-paediatric-use-scientific-guideline" }, { "title": "Clinical investigation of medicinal products in the treatment of urinary incontinence - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/07/2013", "last_updated_date": "19/07/2013", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-urinary-incontinence-scientific-guideline" }, { "title": "Use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/07/2013", "last_updated_date": "12/07/2013", "general_url": "https://www.ema.europa.eu/en/use-starting-materials-intermediates-collected-different-sources-manufacturing-non-recombinant-biological-medicinal-products-scientific-guideline" }, { "title": "Quality of biological active substances produced by transgene expression in animals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/06/2013", "last_updated_date": "10/06/2013", "general_url": "https://www.ema.europa.eu/en/quality-biological-active-substances-produced-transgene-expression-animals-scientific-guideline" }, { "title": "Potential medication errors in the context of benefit risk balance and risk minimisation measures - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "07/06/2013", "last_updated_date": "07/06/2013", "general_url": "https://www.ema.europa.eu/en/potential-medication-errors-context-benefit-risk-balance-risk-minimisation-measures-scientific-guideline" }, { "title": "Use of bovine serum in the manufacture of human biological medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "04/06/2013", "last_updated_date": "04/06/2013", "general_url": "https://www.ema.europa.eu/en/use-bovine-serum-manufacture-human-biological-medicinal-products-scientific-guideline" }, { "title": "ICH Q4B Annex 14 Bacterial endotoxins tests - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/2012", "last_updated_date": "16/05/2013", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-14-bacterial-endotoxins-tests-scientific-guideline" }, { "title": "Documents from advisory groups on clinical-trial data", "summary": "", "categories": "Human", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/clinical-data-publication/documents-advisory-groups-clinical-trial-data" }, { "title": "Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure", "summary": "", "categories": "", "first_published_date": "30/04/2013", "last_updated_date": "30/04/2013", "general_url": "https://www.ema.europa.eu/en/procedural-advice-submission-variations-annual-update-human-influenza-inactivated-vaccines-applications-centralised-procedure" }, { "title": "Extrapolation of efficacy and safety in medicine development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/04/2013", "last_updated_date": "23/04/2013", "general_url": "https://www.ema.europa.eu/en/extrapolation-efficacy-safety-medicine-development-scientific-guideline" }, { "title": "Assessing the toxicological risk to humans and the environment of veterinary pharmaceuticals in groundwater - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/04/2013", "last_updated_date": "19/04/2013", "general_url": "https://www.ema.europa.eu/en/assessing-toxicological-risk-humans-environment-veterinary-pharmaceuticals-groundwater-scientific-guideline" }, { "title": "Immune tolerance induction in haemophilia A patients with inhibitors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/03/2013", "last_updated_date": "26/03/2013", "general_url": "https://www.ema.europa.eu/en/immune-tolerance-induction-haemophilia-patients-inhibitors-scientific-guideline" }, { "title": "Data requirements for intravenous liposomal products developed with reference to an innovator liposomal product - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "general_url": "https://www.ema.europa.eu/en/data-requirements-intravenous-liposomal-products-developed-reference-innovator-liposomal-product-scientific-guideline" }, { "title": "VICH GL50 Harmonisation of criteria to waive target animal batch safety testing for inactivated vaccines for veterinary use - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "general_url": "https://www.ema.europa.eu/en/vich-gl50-harmonisation-criteria-waive-target-animal-batch-safety-testing-inactivated-vaccines-veterinary-use-scientific-guideline" }, { "title": "VICH GL34 Biologicals: testing for the detection of Mycoplasma contamination - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "general_url": "https://www.ema.europa.eu/en/vich-gl34-biologicals-testing-detection-mycoplasma-contamination-scientific-guideline" }, { "title": "VICH GL51 Quality: statistical evaluation of stability data - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "13/03/2013", "last_updated_date": "13/03/2013", "general_url": "https://www.ema.europa.eu/en/vich-gl51-quality-statistical-evaluation-stability-data-scientific-guideline" }, { "title": "Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "08/03/2013", "last_updated_date": "08/03/2013", "general_url": "https://www.ema.europa.eu/en/risk-based-approach-according-annex-i-part-iv-directive-2001-83-ec-applied-advanced-therapy-medicinal-products-scientific-guideline" }, { "title": "Similar biological medicinal products containing recombinant follicle-stimulating hormone - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/03/2013", "last_updated_date": "06/03/2013", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-recombinant-follicle-stimulating-hormone-scientific-guideline" }, { "title": "Similar biological medicinal products containing interferon beta - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/03/2013", "last_updated_date": "06/03/2013", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-interferon-beta-scientific-guideline" }, { "title": "Instrument for Pre-accession Assistance project 2011-2013", "summary": "", "categories": "", "first_published_date": "22/02/2013", "last_updated_date": "22/02/2013", "general_url": "https://www.ema.europa.eu/en/instrument-pre-accession-assistance-project-2011-2013" }, { "title": "Thank you for submitting your request", "summary": "", "categories": "", "first_published_date": "12/02/2013", "last_updated_date": "12/02/2013", "general_url": "https://www.ema.europa.eu/en/thank-you-submitting-your-request" }, { "title": "ICH E16 Genomic biomarkers related to drug response: context, structure and format of qualification submissions - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "11/02/2013", "general_url": "https://www.ema.europa.eu/en/ich-e16-genomic-biomarkers-related-drug-response-context-structure-format-qualification-submissions-scientific-guideline" }, { "title": "ICH Q4B Annex 13 Bulk density and tapped density of powders - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "11/02/2013", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-13-bulk-density-tapped-density-powders-scientific-guideline" }, { "title": "ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/02/2013", "last_updated_date": "11/02/2013", "general_url": "https://www.ema.europa.eu/en/ich-m3-r2-non-clinical-safety-studies-conduct-human-clinical-trials-pharmaceuticals-scientific-guideline" }, { "title": "Management Board: Meetings 2013", "summary": "", "categories": "", "first_published_date": "11/02/2013", "last_updated_date": "11/02/2013", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2013" }, { "title": "ICH Q4B Annex 7 Dissolution test - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2013", "last_updated_date": "01/02/2013", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-7-dissolution-test-scientific-guideline" }, { "title": "W", "summary": "", "categories": "", "first_published_date": "14/01/2013", "last_updated_date": "14/01/2013", "general_url": "https://www.ema.europa.eu/en/w" }, { "title": "U", "summary": "", "categories": "", "first_published_date": "14/01/2013", "last_updated_date": "14/01/2013", "general_url": "https://www.ema.europa.eu/en/u" }, { "title": "V", "summary": "", "categories": "", "first_published_date": "14/01/2013", "last_updated_date": "14/01/2013", "general_url": "https://www.ema.europa.eu/en/v" }, { "title": "T", "summary": "", "categories": "", "first_published_date": "14/01/2013", "last_updated_date": "14/01/2013", "general_url": "https://www.ema.europa.eu/en/t" }, { "title": "Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man - methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/01/2013", "last_updated_date": "11/01/2013", "general_url": "https://www.ema.europa.eu/en/appendix-1-guideline-evaluation-anticancer-medicinal-products-man-methodological-consideration-using-progression-free-survival-pfs-or-disease-free-survival-dfs-confirmatory-trials-scientific-guideline" }, { "title": "ICH E2C (R2) Periodic benefit-risk evaluation report - Scientific guideline", "summary": "This document defines the recommended format and content of a periodic benefit-risk evaluation report (PBRER) and provides an outline of points to be considered in its preparation and submission.", "categories": "Human", "first_published_date": "31/12/2012", "last_updated_date": "31/12/2012", "general_url": "https://www.ema.europa.eu/en/ich-e2c-r2-periodic-benefit-risk-evaluation-report-scientific-guideline" }, { "title": "S", "summary": "", "categories": "", "first_published_date": "11/12/2012", "last_updated_date": "11/12/2012", "general_url": "https://www.ema.europa.eu/en/s" }, { "title": "O", "summary": "", "categories": "", "first_published_date": "10/12/2012", "last_updated_date": "10/12/2012", "general_url": "https://www.ema.europa.eu/en/o" }, { "title": "R", "summary": "", "categories": "", "first_published_date": "10/12/2012", "last_updated_date": "10/12/2012", "general_url": "https://www.ema.europa.eu/en/r" }, { "title": "P", "summary": "", "categories": "", "first_published_date": "10/12/2012", "last_updated_date": "10/12/2012", "general_url": "https://www.ema.europa.eu/en/p" }, { "title": "N", "summary": "", "categories": "", "first_published_date": "10/12/2012", "last_updated_date": "10/12/2012", "general_url": "https://www.ema.europa.eu/en/n" }, { "title": "I", "summary": "", "categories": "", "first_published_date": "07/12/2012", "last_updated_date": "07/12/2012", "general_url": "https://www.ema.europa.eu/en/i" }, { "title": "M", "summary": "", "categories": "", "first_published_date": "07/12/2012", "last_updated_date": "07/12/2012", "general_url": "https://www.ema.europa.eu/en/m" }, { "title": "G", "summary": "", "categories": "", "first_published_date": "06/12/2012", "last_updated_date": "06/12/2012", "general_url": "https://www.ema.europa.eu/en/g" }, { "title": "H", "summary": "", "categories": "", "first_published_date": "06/12/2012", "last_updated_date": "06/12/2012", "general_url": "https://www.ema.europa.eu/en/h" }, { "title": "F", "summary": "", "categories": "", "first_published_date": "06/12/2012", "last_updated_date": "06/12/2012", "general_url": "https://www.ema.europa.eu/en/f" }, { "title": "D", "summary": "", "categories": "", "first_published_date": "04/12/2012", "last_updated_date": "04/12/2012", "general_url": "https://www.ema.europa.eu/en/d" }, { "title": "E", "summary": "", "categories": "", "first_published_date": "04/12/2012", "last_updated_date": "04/12/2012", "general_url": "https://www.ema.europa.eu/en/e" }, { "title": "C", "summary": "", "categories": "", "first_published_date": "03/12/2012", "last_updated_date": "03/12/2012", "general_url": "https://www.ema.europa.eu/en/c" }, { "title": "B", "summary": "", "categories": "", "first_published_date": "03/12/2012", "last_updated_date": "03/12/2012", "general_url": "https://www.ema.europa.eu/en/b" }, { "title": "A", "summary": "", "categories": "", "first_published_date": "30/11/2012", "last_updated_date": "30/11/2012", "general_url": "https://www.ema.europa.eu/en/a" }, { "title": "CHMP Safety Working Party's response to the Paediatric Committee regarding the use of PEGylated drug products in the paediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/11/2012", "last_updated_date": "23/11/2012", "general_url": "https://www.ema.europa.eu/en/chmp-safety-working-partys-response-paediatric-committee-regarding-use-pegylated-drug-products-paediatric-population-scientific-guideline" }, { "title": "Considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/11/2012", "last_updated_date": "21/11/2012", "general_url": "https://www.ema.europa.eu/en/considerations-given-designation-single-stereo-isomeric-form-enantiomer-complex-derivative-or-different-salt-or-ester-new-active-substance-relation-relevant-reference-active-substance-scientific" }, { "title": "Approach to establish a pharmacological acceptable daily intake (ADI) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/11/2012", "last_updated_date": "19/11/2012", "general_url": "https://www.ema.europa.eu/en/approach-establish-pharmacological-acceptable-daily-intake-adi-scientific-guideline" }, { "title": "Clinical investigation of medicinal products, including depot preparations in the treatment of schizophrenia - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/10/2012", "last_updated_date": "09/10/2012", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-including-depot-preparations-treatment-schizophrenia-scientific-guideline" }, { "title": "Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/10/2012", "last_updated_date": "02/10/2012", "general_url": "https://www.ema.europa.eu/en/paediatric-addendum-guideline-clinical-investigation-medicinal-products-treatment-lipid-disorders-scientific-guideline" }, { "title": "Involvement of children and young people at the Paediatric Committee - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/09/2012", "last_updated_date": "17/09/2012", "general_url": "https://www.ema.europa.eu/en/involvement-children-young-people-paediatric-committee-scientific-guideline" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for fludeoxyglucose (18F) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/08/2012", "last_updated_date": "14/08/2012", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-fludeoxyglucose-18f-scientific-guideline" }, { "title": "Clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "08/08/2012", "last_updated_date": "08/08/2012", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-chronic-obstructive-pulmonary-disease-copd-scientific-guideline" }, { "title": "Setting specifications for related impurities in antibiotics - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "13/07/2012", "last_updated_date": "13/07/2012", "general_url": "https://www.ema.europa.eu/en/setting-specifications-related-impurities-antibiotics-scientific-guideline" }, { "title": "Use of herbal medicinal products containing thujone - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "20/02/2012", "last_updated_date": "29/06/2012", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-thujone-scientific-guideline" }, { "title": "Non-pharmacopoeial reference standards for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "27/06/2012", "last_updated_date": "27/06/2012", "general_url": "https://www.ema.europa.eu/en/non-pharmacopoeial-reference-standards-herbal-substances-herbal-preparations-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Similar biological medicinal products containing monoclonal antibodies: non-clinical and clinical issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/06/2012", "last_updated_date": "15/06/2012", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-containing-monoclonal-antibodies-non-clinical-clinical-issues-scientific-guideline" }, { "title": "Immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/06/2012", "last_updated_date": "15/06/2012", "general_url": "https://www.ema.europa.eu/en/immunogenicity-assessment-monoclonal-antibodies-intended-vivo-clinical-use-scientific-guideline" }, { "title": "Plasma master files: application form", "summary": "", "categories": "Human", "first_published_date": "07/06/2012", "last_updated_date": "07/06/2012", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-files-application-form" }, { "title": "Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/05/2012", "last_updated_date": "30/05/2012", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-prevention-venous-thromboembolism-vte-patients-undergoing-high-vte-risk-surgery-scientific-guideline" }, { "title": "Assessment templates and guidance - Ancillary medicinal substances incorporated in a medical device", "summary": "", "categories": "Human", "first_published_date": "10/05/2012", "last_updated_date": "10/05/2012", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/consultation-procedure-ancillary-medicinal-substances-medical-devices/assessment-templates-guidance-ancillary-medicinal-substances-incorporated-medical-device" }, { "title": "Real time release testing - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "14/04/2012", "last_updated_date": "14/04/2012", "general_url": "https://www.ema.europa.eu/en/real-time-release-testing-scientific-guideline" }, { "title": "Management Board: Meetings 2012", "summary": "", "categories": "", "first_published_date": "02/04/2012", "last_updated_date": "02/04/2012", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2012" }, { "title": "DNA vaccines", "summary": "", "categories": "Human", "first_published_date": "30/03/2012", "last_updated_date": "30/03/2012", "general_url": "https://www.ema.europa.eu/en/dna-vaccines" }, { "title": "Infrastructure procedures", "summary": "", "categories": "Corporate", "first_published_date": "23/03/2012", "last_updated_date": "23/03/2012", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/general-procedures/infrastructure-procedures" }, { "title": "Pharmaceutical development of intravenous medicinal products containing active substances solubilised in micellar systems (non-polymeric surfactants) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/03/2012", "last_updated_date": "20/03/2012", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-development-intravenous-medicinal-products-containing-active-substances-solubilised-micellar-systems-non-polymeric-surfactants-scientific-guideline" }, { "title": "Non-clinical and clinical development for oral and topical HIV pre-exposure prophylaxis (PrEP) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/03/2012", "last_updated_date": "15/03/2012", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-development-oral-topical-hiv-pre-exposure-prophylaxis-prep-scientific-guideline" }, { "title": "Risk-mitigation measures related to the environmental risk assessment of veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/03/2012", "last_updated_date": "15/03/2012", "general_url": "https://www.ema.europa.eu/en/risk-mitigation-measures-related-environmental-risk-assessment-veterinary-medicinal-products-scientific-guideline" }, { "title": "Clinical efficacy and safety guidelines: allergy and immunology", "summary": "", "categories": "Human", "first_published_date": "09/03/2012", "last_updated_date": "09/03/2012", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-allergy-immunology" }, { "title": "ICH Quality Implementation Working Group: points to consider for ICH Q8/Q9/Q10 guidelines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/2012", "last_updated_date": "01/03/2012", "general_url": "https://www.ema.europa.eu/en/ich-quality-implementation-working-group-points-consider-ich-q8-q9-q10-guidelines-scientific-guideline" }, { "title": "Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2012", "last_updated_date": "28/02/2012", "general_url": "https://www.ema.europa.eu/en/necessity-initiatives-stimulate-conduct-clinical-studies-herbal-medicinal-products-paediatric-population-scientific-guideline" }, { "title": "Modification of seasonal flu vaccines", "summary": "", "categories": "", "first_published_date": "24/02/2012", "last_updated_date": "24/02/2012", "general_url": "https://www.ema.europa.eu/en/modification-seasonal-flu-vaccines" }, { "title": "Introducing a review and update of existing EU guidelines on residues studies to bring these into line with the VICH metabolism and residues guidelines GL46 to 49 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/02/2012", "last_updated_date": "15/02/2012", "general_url": "https://www.ema.europa.eu/en/introducing-review-update-existing-eu-guidelines-residues-studies-bring-these-line-vich-metabolism-residues-guidelines-gl46-49-scientific-guideline" }, { "title": "Design modifications of gene therapy medicinal products during development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/02/2012", "last_updated_date": "09/02/2012", "general_url": "https://www.ema.europa.eu/en/design-modifications-gene-therapy-medicinal-products-during-development-scientific-guideline" }, { "title": "Use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/02/2012", "last_updated_date": "02/02/2012", "general_url": "https://www.ema.europa.eu/en/use-pharmacogenetic-methodologies-pharmacokinetic-evaluation-medicinal-products-scientific-guideline" }, { "title": "Biocides for use in animal husbandry: guidelines", "summary": "EMA's scientific guidelines on the biocides for use in animal husbandry help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "20/12/2011", "last_updated_date": "20/12/2011", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines/biocides-use-animal-husbandry-guidelines" }, { "title": "Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/12/2011", "last_updated_date": "14/12/2011", "general_url": "https://www.ema.europa.eu/en/warning-transmissible-agents-summary-product-characteristics-package-leaflets-plasma-derived-medicinal-products-scientific-guideline" }, { "title": "ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2011", "last_updated_date": "01/12/2011", "general_url": "https://www.ema.europa.eu/en/ich-s2-r1-genotoxicity-testing-data-interpretation-pharmaceuticals-intended-human-use-scientific-guideline" }, { "title": "Appendix IV of the guideline on the investigation on bioequivalence: presentation of biopharmaceutical and bioanalytical data in module 2.7.1 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/11/2011", "last_updated_date": "18/11/2011", "general_url": "https://www.ema.europa.eu/en/appendix-iv-guideline-investigation-bioequivalence-presentation-biopharmaceutical-bioanalytical-data-module-271-scientific-guideline" }, { "title": "Risk management", "summary": "", "categories": "", "first_published_date": "17/11/2011", "last_updated_date": "17/11/2011", "general_url": "https://www.ema.europa.eu/en/risk-management" }, { "title": "Herbal medicinal products: scientific guidelines", "summary": "The European Medicines Agency's scientific guidelines on herbal medicinal products help medicine developers prepare marketing-authorisation applications for human and veterinary medicines.", "categories": "Human;Herbal", "first_published_date": "07/07/2011", "last_updated_date": "07/10/2011", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/multidisciplinary-guidelines/herbal-medicinal-products-scientific-guidelines" }, { "title": "Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to address indication-specific clinical data requirements - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "06/10/2011", "last_updated_date": "06/10/2011", "general_url": "https://www.ema.europa.eu/en/addendum-note-guidance-evaluation-medicinal-products-indicated-treatment-bacterial-infections-address-indication-specific-clinical-data-requirements-scientific-guideline" }, { "title": "Complaints", "summary": "The European Medicines Agency (EMA) is obliged to acknowledge complaints within two weeks and to respond to complaints within two months. However, the Agency is not obliged to acknowledge complaints that are abusive, excessive in number, repetitive or of pointless character.", "categories": "Corporate", "first_published_date": "30/09/2011", "last_updated_date": "30/09/2011", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/legal-notice/complaints" }, { "title": "Core summary of product characteristics (SmPC) and package leaflet for radiopharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/09/2011", "last_updated_date": "23/09/2011", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-smpc-package-leaflet-radiopharmaceuticals-scientific-guideline" }, { "title": "Transfer of a marketing authorisation templates", "summary": "", "categories": "Human", "first_published_date": "10/06/2010", "last_updated_date": "21/09/2011", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answers/transfer-marketing-authorisation-templates" }, { "title": "ICH E2F Development safety update report - Scientific guideline", "summary": "This document proposes a common standard for periodic reporting on drugs under development among the ICH regions - the development safety update report (DSUR). It defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.", "categories": "Human", "first_published_date": "01/09/2011", "last_updated_date": "01/09/2011", "general_url": "https://www.ema.europa.eu/en/ich-e2f-development-safety-update-report-scientific-guideline" }, { "title": "Quality aspects on the isolation of candidate influenza vaccine viruses in cell culture - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/08/2011", "last_updated_date": "17/08/2011", "general_url": "https://www.ema.europa.eu/en/quality-aspects-isolation-candidate-influenza-vaccine-viruses-cell-culture-scientific-guideline" }, { "title": "Annex I variation application(s) content for live attenuated influenza vaccines", "summary": "", "categories": "", "first_published_date": "08/08/2011", "last_updated_date": "08/08/2011", "general_url": "https://www.ema.europa.eu/en/annex-i-variation-applications-content-live-attenuated-influenza-vaccines" }, { "title": "Treatment of premenstrual dysphoric disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "05/08/2011", "last_updated_date": "05/08/2011", "general_url": "https://www.ema.europa.eu/en/treatment-premenstrual-dysphoric-disorder-scientific-guideline" }, { "title": "Plasma-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/2011", "last_updated_date": "29/07/2011", "general_url": "https://www.ema.europa.eu/en/plasma-derived-medicinal-products-scientific-guideline" }, { "title": "Pre-clinical safety evaluation of biotechnology-derived pharmaceuticals (ICH S6 [R1])", "summary": "", "categories": "", "first_published_date": "30/09/1997", "last_updated_date": "25/07/2011", "general_url": "https://www.ema.europa.eu/en/pre-clinical-safety-evaluation-biotechnology-derived-pharmaceuticals-ich-s6-r1" }, { "title": "Active Substance Master File Working Group", "summary": "The Working Group on Active Substance Master File Procedures (ASMF WG) provides advice on the procedural aspects of the assessment of active substance master files (ASMFs) to EMA's Committees for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP) and the Coordination Groups for Mutual Recognition and Decentralised Procedures (CMDh and CMDv).", "categories": "Human;Veterinary", "first_published_date": "18/07/2011", "last_updated_date": "18/07/2011", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/active-substance-master-file-working-group" }, { "title": "Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/07/2011", "last_updated_date": "12/07/2011", "general_url": "https://www.ema.europa.eu/en/methodological-issues-pharmacogenomic-biomarkers-relation-clinical-development-patient-selection-scientific-guideline" }, { "title": "Creutzfeldt-Jakob disease and advanced therapy medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/06/2011", "last_updated_date": "28/06/2011", "general_url": "https://www.ema.europa.eu/en/creutzfeldt-jakob-disease-advanced-therapy-medicinal-products-scientific-guideline" }, { "title": "Management Board: Meetings 2011", "summary": "", "categories": "", "first_published_date": "29/03/2011", "last_updated_date": "27/06/2011", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2011-0" }, { "title": "Management Board: Meetings 2011", "summary": "", "categories": "", "first_published_date": "23/06/2011", "last_updated_date": "23/06/2011", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2011" }, { "title": "Therapeutic areas: latest updates", "summary": "Find the latest updates from the European Medicines Agency on cancer, cardiovascular diseases, diabetes, HIV and AIDS, neurodegenerative diseases, immune-system diseases and viral diseases. Updates include the news and recently updated medicines authorised for the European Union, news and upcoming events.", "categories": "", "first_published_date": "02/05/2011", "last_updated_date": "02/05/2011", "general_url": "https://www.ema.europa.eu/en/medicines/therapeutic-areas-latest-updates" }, { "title": "Agency in numbers", "summary": "", "categories": "", "first_published_date": "14/04/2011", "last_updated_date": "14/04/2011", "general_url": "https://www.ema.europa.eu/en/agency-numbers" }, { "title": "VICH GL46 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: metabolism study to determine the quantity and identify the nature of residues - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/04/2011", "last_updated_date": "07/04/2011", "general_url": "https://www.ema.europa.eu/en/vich-gl46-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-animals-metabolism-study-determine-quantity-identify-nature-residues-scientific-guideline" }, { "title": "VICH GL47 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: laboratory animal comparative metabolism studies - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/04/2011", "last_updated_date": "07/04/2011", "general_url": "https://www.ema.europa.eu/en/vich-gl47-studies-evaluate-metabolism-residue-kinetics-veterinary-drugs-food-producing-animals-laboratory-animal-comparative-metabolism-studies-scientific-guideline" }, { "title": "Potency declaration/labelling for biological medicinal products which contain modified proteins as active substance - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/03/2011", "last_updated_date": "14/03/2011", "general_url": "https://www.ema.europa.eu/en/potency-declaration-labelling-biological-medicinal-products-which-contain-modified-proteins-active-substance-scientific-guideline" }, { "title": "Evaluation of drugs for the treatment of gastroesophageal reflux disease (GORD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/03/2011", "last_updated_date": "14/03/2011", "general_url": "https://www.ema.europa.eu/en/evaluation-drugs-treatment-gastroesophageal-reflux-disease-gord-scientific-guideline" }, { "title": "Medicinal products for the treatment of insomnia - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/02/2011", "last_updated_date": "25/02/2011", "general_url": "https://www.ema.europa.eu/en/medicinal-products-treatment-insomnia-scientific-guideline" }, { "title": "Herbal medicinal products: Regulatory and procedural guidance", "summary": "", "categories": "Herbal", "first_published_date": "31/12/2009", "last_updated_date": "16/02/2011", "general_url": "https://www.ema.europa.eu/en/herbal-medicinal-products-regulatory-procedural-guidance" }, { "title": "Meticillin-resistant Staphylococcus pseudintermedius - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/02/2011", "last_updated_date": "10/02/2011", "general_url": "https://www.ema.europa.eu/en/meticillin-resistant-staphylococcus-pseudintermedius-scientific-guideline" }, { "title": "Stem cell-based medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "03/02/2011", "last_updated_date": "03/02/2011", "general_url": "https://www.ema.europa.eu/en/stem-cell-based-medicinal-products-scientific-guideline" }, { "title": "Need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/01/2011", "last_updated_date": "11/01/2011", "general_url": "https://www.ema.europa.eu/en/need-active-control-therapeutic-areas-where-use-placebo-deemed-ethical-one-or-more-established-medicines-are-available-scientific-guideline" }, { "title": "Level of purification of extracts to be considered as herbal preparations - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "03/01/2011", "last_updated_date": "03/01/2011", "general_url": "https://www.ema.europa.eu/en/level-purification-extracts-be-considered-herbal-preparations-scientific-guideline" }, { "title": "European Technology Platform for Global Animal Health", "summary": "", "categories": "", "first_published_date": "13/12/2010", "last_updated_date": "13/12/2010", "general_url": "https://www.ema.europa.eu/en/european-technology-platform-global-animal-health" }, { "title": "Vaccine availability survey", "summary": "", "categories": "Veterinary", "first_published_date": "13/12/2010", "last_updated_date": "13/12/2010", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-and-development-veterinary-medicines/availability-veterinary-vaccines/vaccine-availability-survey" }, { "title": "EMA/CAT and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group", "summary": "", "categories": "Human", "first_published_date": "06/12/2010", "last_updated_date": "06/12/2010", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cat/ema-cat-medical-devices-notified-body-ema-cat-nb-collaboration-group" }, { "title": "Data to be provided in support of a request to include a substance in the list of substances considered as not falling within the scope of regulation (EC) No 470/2009 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/11/2010", "last_updated_date": "18/11/2010", "general_url": "https://www.ema.europa.eu/en/data-be-provided-support-request-include-substance-list-substances-considered-not-falling-within-scope-regulation-ec-no-470-2009-scientific-guideline" }, { "title": "Stability testing of herbal medicinal products and traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "12/11/2010", "last_updated_date": "12/11/2010", "general_url": "https://www.ema.europa.eu/en/stability-testing-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "ICH M2 Business requirements - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2009", "last_updated_date": "24/09/2010", "general_url": "https://www.ema.europa.eu/en/ich-m2-business-requirements-scientific-guideline" }, { "title": "ICH M2 Electronic common technical document (eCTD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/05/2004", "last_updated_date": "24/09/2010", "general_url": "https://www.ema.europa.eu/en/ich-m2-electronic-common-technical-document-ectd-scientific-guideline" }, { "title": "Missing data in confirmatory clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2010", "last_updated_date": "20/09/2010", "general_url": "https://www.ema.europa.eu/en/missing-data-confirmatory-clinical-trials-scientific-guideline" }, { "title": "Addendum to the note for guidance on antiarrhythmics on atrial fibrillation and atrial flutter - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2010", "last_updated_date": "20/09/2010", "general_url": "https://www.ema.europa.eu/en/addendum-note-guidance-antiarrhythmics-atrial-fibrillation-atrial-flutter-scientific-guideline" }, { "title": "Networks", "summary": "", "categories": "", "first_published_date": "10/09/2010", "last_updated_date": "10/09/2010", "general_url": "https://www.ema.europa.eu/en/partners-networks/networks" }, { "title": "ICH Q4B Annex 11 Capillary electrophoresis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/09/2010", "last_updated_date": "01/09/2010", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-11-capillary-electrophoresis-scientific-guideline" }, { "title": "Quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/08/2010", "last_updated_date": "10/08/2010", "general_url": "https://www.ema.europa.eu/en/quality-non-clinical-clinical-aspects-live-recombinant-viral-vectored-vaccines-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of attention deficit hyperactivity disorder (ADHD) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "05/08/2010", "last_updated_date": "05/08/2010", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-attention-deficit-hyperactivity-disorder-adhd-scientific-guideline" }, { "title": "Clinical efficacy and safety: radiopharmaceuticals and diagnostic agents guidelines", "summary": "", "categories": "Human", "first_published_date": "29/07/2010", "last_updated_date": "29/07/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-radiopharmaceuticals-diagnostic-agents-guidelines" }, { "title": "ICH E7 Studies in support of special populations: geriatrics - questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2010", "last_updated_date": "27/07/2010", "general_url": "https://www.ema.europa.eu/en/ich-e7-studies-support-special-populations-geriatrics-questions-answers-scientific-guideline" }, { "title": "Non-clinical evaluation of drug-induced liver injury (DILI) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/07/2010", "last_updated_date": "19/07/2010", "general_url": "https://www.ema.europa.eu/en/non-clinical-evaluation-drug-induced-liver-injury-dili-scientific-guideline" }, { "title": "Questions and answers on the withdrawal of the note for guidance on single dose toxicity - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/07/2010", "last_updated_date": "19/07/2010", "general_url": "https://www.ema.europa.eu/en/questions-answers-withdrawal-note-guidance-single-dose-toxicity-scientific-guideline" }, { "title": "Internal error", "summary": "", "categories": "", "first_published_date": "17/06/2010", "last_updated_date": "17/06/2010", "general_url": "https://www.ema.europa.eu/en/internal-error" }, { "title": "Need for a guideline on the clinical development of thrombopoetin receptor agonists for the treatment of chronic immune (idiopathic) thrombocytopenic purpura - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/06/2010", "last_updated_date": "13/06/2010", "general_url": "https://www.ema.europa.eu/en/need-guideline-clinical-development-thrombopoetin-receptor-agonists-treatment-chronic-immune-idiopathic-thrombocytopenic-purpura-scientific-guideline" }, { "title": "VICH GL45 Bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "28/05/2010", "last_updated_date": "28/05/2010", "general_url": "https://www.ema.europa.eu/en/vich-gl45-bracketing-matrixing-designs-stability-testing-new-veterinary-drug-substances-medicinal-products-scientific-guideline" }, { "title": "Core management documents", "summary": "", "categories": "", "first_published_date": "26/05/2010", "last_updated_date": "26/05/2010", "general_url": "https://www.ema.europa.eu/en/core-management-documents" }, { "title": "Co-ordinating bodies", "summary": "", "categories": "", "first_published_date": "26/05/2010", "last_updated_date": "26/05/2010", "general_url": "https://www.ema.europa.eu/en/co-ordinating-bodies" }, { "title": "In-vitro cultured chondrocyte containing products for cartilage repair of the knee - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/05/2010", "last_updated_date": "18/05/2010", "general_url": "https://www.ema.europa.eu/en/vitro-cultured-chondrocyte-containing-products-cartilage-repair-knee-scientific-guideline" }, { "title": "Marketing and cessation notification: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "07/05/2010", "last_updated_date": "07/05/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/notifying-change-marketing-status/marketing-cessation-notification-regulatory-procedural-guidance" }, { "title": "Transparency: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "07/05/2010", "last_updated_date": "07/05/2010", "general_url": "https://www.ema.europa.eu/en/transparency-regulatory-procedural-guidance" }, { "title": "Clinical evaluation of antifungal agents for the treatment and prophylaxis invasive fungal disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/04/2010", "last_updated_date": "30/04/2010", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-antifungal-agents-treatment-prophylaxis-invasive-fungal-disease-scientific-guideline" }, { "title": "Clinical efficacy and safety guidelines: respiratory system", "summary": "", "categories": "Human", "first_published_date": "28/04/2010", "last_updated_date": "28/04/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-respiratory-system" }, { "title": "Environmental risk assessment of herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "28/04/2010", "last_updated_date": "28/04/2010", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessment-herbal-medicinal-products-scientific-guideline" }, { "title": "Immunologicals: guidelines - Veterinary limited markets", "summary": "The European Medicines Agency's scientific guidelines on the availability of immunologicals help medicine developers prepare marketing authorisation applications for veterinary medicines.", "categories": "Veterinary", "first_published_date": "27/04/2010", "last_updated_date": "27/04/2010", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/immunologicals-guidelines/immunologicals-guidelines-veterinary-limited-markets" }, { "title": "Quality: Multidisciplinary", "summary": "", "categories": "", "first_published_date": "26/04/2010", "last_updated_date": "26/04/2010", "general_url": "https://www.ema.europa.eu/en/quality-multidisciplinary" }, { "title": "Safety and residues guidelines: Multidisciplinary", "summary": "", "categories": "Veterinary", "first_published_date": "26/04/2010", "last_updated_date": "26/04/2010", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/safety-residues-guidelines/safety-residues-guidelines-multidisciplinary" }, { "title": "Pandemic influenza: news archive", "summary": "", "categories": "Human", "first_published_date": "24/04/2010", "last_updated_date": "24/04/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/2009-h1n1-influenza-pandemic/pandemic-influenza-news-archive" }, { "title": "Relenza", "summary": "", "categories": "", "first_published_date": "09/04/2010", "last_updated_date": "09/04/2010", "general_url": "https://www.ema.europa.eu/en/relenza" }, { "title": "Clinical efficacy and safety guidelines: dermatologicals", "summary": "", "categories": "Human", "first_published_date": "31/03/2010", "last_updated_date": "31/03/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-dermatologicals" }, { "title": "Clinical efficacy and safety guidelines: genitourinary system and sex hormones", "summary": "", "categories": "Human", "first_published_date": "31/03/2010", "last_updated_date": "31/03/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-genitourinary-system-sex-hormones" }, { "title": "Transfer of orphan designation", "summary": "", "categories": "", "first_published_date": "30/03/2010", "last_updated_date": "30/03/2010", "general_url": "https://www.ema.europa.eu/en/transfer-orphan-designation" }, { "title": "Clinical efficacy and safety guidelines: blood and blood-forming organs", "summary": "", "categories": "Human", "first_published_date": "29/03/2010", "last_updated_date": "29/03/2010", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/clinical-efficacy-safety-guidelines-blood-blood-forming-organs" }, { "title": "Repeated dose toxicity - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/03/2010", "last_updated_date": "29/03/2010", "general_url": "https://www.ema.europa.eu/en/repeated-dose-toxicity-scientific-guideline" }, { "title": "Management Board: Meetings 2010", "summary": "", "categories": "", "first_published_date": "26/03/2010", "last_updated_date": "26/03/2010", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2010" }, { "title": "Demonstration of a possible impact of maternally derived antibodies on vaccine efficacy in young animals - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/03/2010", "last_updated_date": "18/03/2010", "general_url": "https://www.ema.europa.eu/en/demonstration-possible-impact-maternally-derived-antibodies-vaccine-efficacy-young-animals-scientific-guideline" }, { "title": "Data requirements to support in-use stability claims for veterinary vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/03/2010", "last_updated_date": "18/03/2010", "general_url": "https://www.ema.europa.eu/en/data-requirements-support-use-stability-claims-veterinary-vaccines-scientific-guideline" }, { "title": "Control of the active substance in the finished product for immunological veterinary medicinal products (IVMPs) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/03/2010", "last_updated_date": "18/03/2010", "general_url": "https://www.ema.europa.eu/en/control-active-substance-finished-product-immunological-veterinary-medicinal-products-ivmps-scientific-guideline" }, { "title": "Development of medicinal products for the treatment of alcohol dependence - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/2010", "last_updated_date": "01/03/2010", "general_url": "https://www.ema.europa.eu/en/development-medicinal-products-treatment-alcohol-dependence-scientific-guideline" }, { "title": "Data requirements for swine influenza vaccines against pandemic (H1N1) 2009 influenza - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/02/2010", "last_updated_date": "16/02/2010", "general_url": "https://www.ema.europa.eu/en/data-requirements-swine-influenza-vaccines-against-pandemic-h1n1-2009-influenza-scientific-guideline" }, { "title": "Ethanol content in herbal medicinal products and traditional herbal medicinal products used in children - Scientific guideline", "summary": "", "categories": "Herbal", "first_published_date": "01/02/2010", "last_updated_date": "01/02/2010", "general_url": "https://www.ema.europa.eu/en/ethanol-content-herbal-medicinal-products-traditional-herbal-medicinal-products-used-children-scientific-guideline" }, { "title": "Need for an addendum on the clinical investigation of medicinal products intended for treatment of glucocorticoid-induced osteoporosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/01/2010", "last_updated_date": "29/01/2010", "general_url": "https://www.ema.europa.eu/en/need-addendum-clinical-investigation-medicinal-products-intended-treatment-glucocorticoid-induced-osteoporosis-scientific-guideline" }, { "title": "Selection of test materials for genotoxicity testing for traditional herbal medicinal products/herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "18/01/2010", "last_updated_date": "18/01/2010", "general_url": "https://www.ema.europa.eu/en/selection-test-materials-genotoxicity-testing-traditional-herbal-medicinal-products-herbal-medicinal-products-scientific-guideline" }, { "title": "Questions and answers on gene therapy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/01/2010", "last_updated_date": "12/01/2010", "general_url": "https://www.ema.europa.eu/en/questions-answers-gene-therapy-scientific-guideline" }, { "title": "CAT members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee for Advanced Therapies (CAT).", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat/cat-members" }, { "title": "CHMP members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee for Medicinal Products for Human Use (CHMP).", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp/chmp-members" }, { "title": "COMP members", "summary": "The European Medicines Agency (EMA) publishes details of the members of its Committee for Orphan Medicinal Products (COMP).", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/committee-orphan-medicinal-products-comp/comp-members" }, { "title": "CVMP members", "summary": "The European Medicines Agency (EMA) publishes details of the members and alternates of its Committee for Veterinary Medicinal Products (CVMP).", "categories": "Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/committee-veterinary-medicinal-products-cvmp/cvmp-members" }, { "title": "Efficacy Working Party", "summary": "The Efficacy Working Party (EWP-V) provides recommendations to the Committee for Veterinary Medicinal Products (CVMP) on all matters relating to the efficacy of non-immunological veterinary medicinal products, including target animal safety.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/cvmp/efficacy-working-party" }, { "title": "Efficacy Working Party (EWP)", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/efficacy-working-party-ewp" }, { "title": "Information systems", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/information-systems" }, { "title": "Document and information management procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/general-procedures/document-information-management-procedures" }, { "title": "Finance procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/general-procedures/finance-procedures" }, { "title": "Modifications to templates (Paediatrics)", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/modifications-templates-paediatrics" }, { "title": "Pharmacovigilance procedures for human medicines", "summary": "", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/pharmacovigilance-procedures/pharmacovigilance-procedures-human-medicines" }, { "title": "Committee highlights", "summary": "The European Medicines Agency (EMA) publishes the agendas and outcomes of the monthly plenary meetings of its seven scientific committees.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/news-events/committee-highlights" }, { "title": "Integrated management system", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/integrated-management-system" }, { "title": "CAT Documents", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/cat-documents" }, { "title": "Questions and answers: Orphan-designation application", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/orphan-designation-research-and-development/applying-orphan-designation/questions-answers-orphan-designation-application" }, { "title": "Regulation of Human medicines - News", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/regulation-human-medicines-news" }, { "title": "HMPC Documents", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/hmpc-documents" }, { "title": "Legislative issues", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/legislative-issues" }, { "title": "Meeting management procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/meeting-management-procedures" }, { "title": "Plasma master file (PMF) certification", "summary": "The plasma master file (PMF) is a compilation of all the required scientific data on the quality and safety of human plasma relevant to the medicines, medical devices and investigational products that use human plasma in their manufacture. These data cover all aspects of the use of plasma, from collection to plasma pool.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification" }, { "title": "Plasma Master File (PMF) background documents", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-pmf-background-documents" }, { "title": "Certification of medicinal products", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/certification-medicinal-products" }, { "title": "Orphan incentives", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/orphan-incentives" }, { "title": "Haematology Working Party documents", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-domains/chmp/haematology-working-party/haematology-working-party-documents" }, { "title": "CVMP Documents", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/cvmp-documents" }, { "title": "Maximum residue limits procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures/maximum-residue-limits-procedures" }, { "title": "Fees", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/fees" }, { "title": "Veterinary Medicines - Availability (minor uses/minor species)", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/veterinary-medicines-availability-minor-uses-minor-species" }, { "title": "Product information: Reference documents and guidelines", "summary": "This page lists the reference documents and guidelines on the quality of product information for centrally authorised veterinary medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/product-information-reference-documents-guidelines" }, { "title": "Referral opinions pending EC decision", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/referral-opinions-pending-ec-decision" }, { "title": "Final referral decisions", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/final-referral-decisions" }, { "title": "Regulation of Human medicines", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/regulation-human-medicines" }, { "title": "PDCO Documents", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/pdco-documents" }, { "title": "Inspection activities procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/inspection-activities-procedures" }, { "title": "Product development procedures", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures" }, { "title": "Biological guidelines", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guidelines" }, { "title": "Product information", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-information" }, { "title": "Initial evaluation procedures", "summary": "", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-authorisation-lifecycle-procedures/initial-evaluation-procedures" }, { "title": "Post-authorisation procedures", "summary": "", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-authorisation-lifecycle-procedures/post-authorisation-procedures" }, { "title": "Plasma Master File (PMF) procedural guidelines", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-pmf-procedural-guidelines" }, { "title": "Pharmacovigilance procedures for veterinary medicines", "summary": "", "categories": "Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/pharmacovigilance-procedures/pharmacovigilance-procedures-veterinary-medicines" }, { "title": "Post-assessment guidance", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/post-assessment-guidance" }, { "title": "Working with stakeholders", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/working-stakeholders" }, { "title": "Centralised procedure procedures", "summary": "", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-authorisation-lifecycle-procedures/centralised-procedure-procedures" }, { "title": "Post-authorisation: Background information", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/post-authorisation-background-information" }, { "title": "Coordination of GCP inspections", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/coordination-gcp-inspections" }, { "title": "Referrals procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/referrals-procedures" }, { "title": "Management Board: Meetings 2009", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/management-board-meetings-2009" }, { "title": "GMP/GDP Inspections Working Party", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/gmp-gdp-inspections-working-party" }, { "title": "Scientific guidelines", "summary": "The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines" }, { "title": "Paediatrics: Regulatory and procedural guidance", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/paediatrics-regulatory-procedural-guidance" }, { "title": "General: Regulatory and procedural guidance", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/general-regulatory-procedural-guidance" }, { "title": "Supporting information", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/supporting-information" }, { "title": "EU Member States", "summary": "The European Medicines Agency (EMA) works closely with the human and veterinary medicines regulatory authorities of the Member States of the European Union (EU) and the European Economic Area (EEA).", "categories": "Human;Veterinary;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/partners-networks/eu-partners/eu-member-states" }, { "title": "Product authorisation lifecycle procedures", "summary": "", "categories": "Human;Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-authorisation-lifecycle-procedures" }, { "title": "Scientific advice procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/product-development-procedures/scientific-advice-procedures" }, { "title": "Work programmes", "summary": "This page lists the European Medicines Agency's work programmes.", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/work-programmes" }, { "title": "Data exclusivity / Generics / Biosimilars: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/data-exclusivity-generics-biosimilars-regulatory-procedural-guidance" }, { "title": "Coordination of GLP inspections", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/coordination-glp-inspections" }, { "title": "Plasma Master File dossier format and submission requirements", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-dossier-format-submission-requirements" }, { "title": "Non-clinical guidelines", "summary": "The European Medicines Agency's scientific guidelines on the non-clinical testing of medicines help applicants prepare marketing authorisation applications. Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the requirements for the demonstration of quality, safety and efficacy set out in the Community directives.", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/non-clinical-guidelines" }, { "title": "Pharmacovigilance procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/pharmacovigilance-procedures" }, { "title": "General procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/general-procedures" }, { "title": "Further resources", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/further-resources" }, { "title": "Non-pharmaceutical products", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/non-pharmaceutical-products" }, { "title": "Parallel distribution", "summary": "", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/parallel-distribution" }, { "title": "Forms and templates", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/forms-templates" }, { "title": "Sampling and testing: questions and answers", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/compliance-marketing-authorisation-0/sampling-and-testing/sampling-testing-questions-answers" }, { "title": "Procedures", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/procedures" }, { "title": "Types of contract", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/types-contract" }, { "title": "Post opinion: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/post-opinion-regulatory-procedural-guidance" }, { "title": "Inspections procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/inspection-activities-procedures/inspections-procedures" }, { "title": "Herbal medicinal products", "summary": "The Committee on Herbal Medicinal Products (HMPC) issues scientific opinions on herbal substances and preparations, along with information on recommended uses and safe conditions, on behalf of the European Medicines Agency (EMA). This gives companies and national competent authorities a clear reference point when preparing or assessing an application for marketing authorisation or registration of herbal medicinal products in European Union (EU) Member States.", "categories": "Herbal", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/herbal-medicinal-products" }, { "title": "Questions and Answers on ketoprofen, ketorolac and piroxicam", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/questions-answers-ketoprofen-ketorolac-piroxicam" }, { "title": "Scientific and regulatory meetings procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/meeting-management-procedures/scientific-regulatory-meetings-procedures" }, { "title": "Governance procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/general-procedures/governance-procedures" }, { "title": "COMP Documents", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/comp-documents" }, { "title": "Parallel distribution (human medicines) procedures", "summary": "", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-and-reporting/policies-and-procedures/inspection-activities-procedures/parallel-distribution-human-medicines-procedures" }, { "title": "Maximum Residue Limits Q&A: Introduction", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/maximum-residue-limits-qa-introduction" }, { "title": "ICH guidelines", "summary": "The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/ich-guidelines" }, { "title": "Pandemic influenza pharmacovigilance updates", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/pandemic-influenza/2009-h1n1-influenza-pandemic/pandemic-influenza-pharmacovigilance-updates" }, { "title": "Coordination of GCP inspections", "summary": "", "categories": "", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/coordination-gcp-inspections" }, { "title": "Referral procedures: Regulatory and procedural guidance", "summary": "", "categories": "Human", "first_published_date": "31/12/2009", "last_updated_date": "31/12/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/referral-procedures-regulatory-procedural-guidance" }, { "title": "ICH Q4B Annex 10 Polyacrylamide gel electrophoresis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2009", "last_updated_date": "01/12/2009", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-10-polyacrylamide-gel-electrophoresis-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of pulmonary arterial hypertension - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2009", "last_updated_date": "01/12/2009", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-pulmonary-arterial-hypertension-scientific-guideline" }, { "title": "ICH 4 QB Annex 9 Tablet friability - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2009", "last_updated_date": "01/12/2009", "general_url": "https://www.ema.europa.eu/en/ich-4-qb-annex-9-tablet-friability-scientific-guideline" }, { "title": "Xenogeneic cell-based medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/2009", "last_updated_date": "30/11/2009", "general_url": "https://www.ema.europa.eu/en/xenogeneic-cell-based-medicinal-products-scientific-guideline" }, { "title": "Efficacy Working Party documents", "summary": "", "categories": "", "first_published_date": "23/11/2009", "last_updated_date": "23/11/2009", "general_url": "https://www.ema.europa.eu/en/efficacy-working-party-documents" }, { "title": "Vaccines Working Party documents", "summary": "", "categories": "Human", "first_published_date": "23/11/2009", "last_updated_date": "23/11/2009", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/vaccines-working-party/vaccines-working-party-documents" }, { "title": "Quality of medicines: questions and answers - Introduction", "summary": "", "categories": "Human;Veterinary", "first_published_date": "17/11/2009", "last_updated_date": "17/11/2009", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/quality-medicines-questions-answers-introduction" }, { "title": "Quality of medicines: questions and answers - Introduction", "summary": "", "categories": "Veterinary", "first_published_date": "17/11/2009", "last_updated_date": "17/11/2009", "general_url": "https://www.ema.europa.eu/en/quality-medicines-questions-answers-introduction" }, { "title": "Follow-up of patients administered with gene therapy medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/11/2009", "last_updated_date": "12/11/2009", "general_url": "https://www.ema.europa.eu/en/follow-patients-administered-gene-therapy-medicinal-products-scientific-guideline" }, { "title": "Extrapolation of results from clinical studies conducted outside Europe to the EU-population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/11/2009", "last_updated_date": "12/11/2009", "general_url": "https://www.ema.europa.eu/en/extrapolation-results-clinical-studies-conducted-outside-europe-eu-population-scientific-guideline" }, { "title": "ICH Considerations: oncolytic viruses - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/10/2009", "last_updated_date": "21/10/2009", "general_url": "https://www.ema.europa.eu/en/ich-considerations-oncolytic-viruses-scientific-guideline" }, { "title": "Higher-tier testing of veterinary medicinal products to dung fauna - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "23/09/2009", "last_updated_date": "23/09/2009", "general_url": "https://www.ema.europa.eu/en/higher-tier-testing-veterinary-medicinal-products-dung-fauna-scientific-guideline" }, { "title": "Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/07/2009", "last_updated_date": "23/07/2009", "general_url": "https://www.ema.europa.eu/en/appendix-1-guideline-clinical-evaluation-diagnostic-agents-imaging-agents-scientific-guideline" }, { "title": "Data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPS) by new master seed of the same origin - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/07/2009", "last_updated_date": "20/07/2009", "general_url": "https://www.ema.europa.eu/en/data-requirements-replacement-established-master-seeds-ms-already-used-authorised-immunological-veterinary-medicinal-products-ivmps-new-master-seed-same-origin-scientific-guideline" }, { "title": "ICH Considerations: general principles to address virus and vector shedding - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2009", "last_updated_date": "01/07/2009", "general_url": "https://www.ema.europa.eu/en/ich-considerations-general-principles-address-virus-vector-shedding-scientific-guideline" }, { "title": "Questions and answers on the possibility to extrapolate pre-inactivation titres as part of validation of an inactivation process - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/06/2009", "last_updated_date": "22/06/2009", "general_url": "https://www.ema.europa.eu/en/questions-answers-possibility-extrapolate-pre-inactivation-titres-part-validation-inactivation-process-scientific-guideline" }, { "title": "Joint scientific report of ECDC, EFSA and EMA on meticillin-resistant Staphylococcus aureus (MRSA) in livestock, companion animals and food", "summary": "", "categories": "Veterinary", "first_published_date": "16/06/2009", "last_updated_date": "16/06/2009", "general_url": "https://www.ema.europa.eu/en/joint-scientific-report-ecdc-efsa-ema-meticillin-resistant-staphylococcus-aureus-mrsa-livestock-companion-animals-food" }, { "title": "ICH Q8 (R2) Pharmaceutical development - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2009", "last_updated_date": "01/06/2009", "general_url": "https://www.ema.europa.eu/en/ich-q8-r2-pharmaceutical-development-scientific-guideline" }, { "title": "ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2009", "last_updated_date": "01/06/2009", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-4a-microbiological-examination-non-sterile-products-microbial-enumeration-tests-scientific-guideline" }, { "title": "ICH Q4B Annex 5 Disintegration test - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2009", "last_updated_date": "01/06/2009", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-5-disintegration-test-scientific-guideline" }, { "title": "ICH Q4B Annex 8 Sterility test - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2009", "last_updated_date": "01/06/2009", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-8-sterility-test-scientific-guideline" }, { "title": "Non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-development-similar-biological-medicinal-products-containing-recombinant-interferon-alpha-or-pegylated-recombinant-interferon-alpha-scientific-guideline" }, { "title": "Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-direct-acting-antiviral-agents-intended-treatment-chronic-hepatitis-c-scientific-guideline" }, { "title": "Replacement of rabbit pyrogen testing by an alternative test for plasma derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/04/2009", "last_updated_date": "23/04/2009", "general_url": "https://www.ema.europa.eu/en/replacement-rabbit-pyrogen-testing-alternative-test-plasma-derived-medicinal-products-scientific-guideline" }, { "title": "VICH GL33 Safety studies for veterinary drug residues in human food: general approach to testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "20/04/2009", "last_updated_date": "20/04/2009", "general_url": "https://www.ema.europa.eu/en/vich-gl33-safety-studies-veterinary-drug-residues-human-food-general-approach-testing-scientific-guideline" }, { "title": "Meticillin-resistant Staphylococcus aureus in food-producing and companion animals in the European Union: epidemiology and control options for human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "26/03/2009", "last_updated_date": "26/03/2009", "general_url": "https://www.ema.europa.eu/en/meticillin-resistant-staphylococcus-aureus-food-producing-companion-animals-european-union-epidemiology-control-options-human-animal-health-scientific-guideline" }, { "title": "Non-clinical and clinical development of similar biological medicinal products containing low-molecular-weight heparins - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/03/2009", "last_updated_date": "19/03/2009", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-development-similar-biological-medicinal-products-containing-low-molecular-weight-heparins-scientific-guideline" }, { "title": "Use of third- and fourth-generation cephalosporins in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/03/2009", "last_updated_date": "16/03/2009", "general_url": "https://www.ema.europa.eu/en/use-third-fourth-generation-cephalosporins-food-producing-animals-european-union-development-resistance-impact-human-animal-health-scientific-guideline" }, { "title": "Dossier structure and content for pandemic-influenza-vaccine marketing-authorisation application - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/12/2008", "last_updated_date": "18/12/2008", "general_url": "https://www.ema.europa.eu/en/dossier-structure-content-pandemic-influenza-vaccine-marketing-authorisation-application-scientific-guideline" }, { "title": "ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2008", "last_updated_date": "01/12/2008", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-4c-test-microbiological-examination-non-sterile-products-acceptance-criteria-pharmaceutical-preparations-substances-pharmaceutical-use-scientific-guideline" }, { "title": "ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified microorganisms - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/2008", "last_updated_date": "01/12/2008", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-4b-test-microbiological-examination-non-sterile-products-tests-specified-microorganisms-scientific-guideline" }, { "title": "Clinical development of medicinal products for treatment of HIV infection - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-treatment-hiv-infection-scientific-guideline" }, { "title": "Clinical development of products for specific immunotherapy for the treatment of allergic diseases - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "general_url": "https://www.ema.europa.eu/en/clinical-development-products-specific-immunotherapy-treatment-allergic-diseases-scientific-guideline" }, { "title": "Allergen products: production and quality issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/11/2008", "last_updated_date": "20/11/2008", "general_url": "https://www.ema.europa.eu/en/allergen-products-production-quality-issues-scientific-guideline" }, { "title": "Requirements for an authorisation under exceptional circumstances for vaccines for emergency use against bluetongue", "summary": "", "categories": "Veterinary", "first_published_date": "17/11/2008", "last_updated_date": "17/11/2008", "general_url": "https://www.ema.europa.eu/en/requirements-authorisation-under-exceptional-circumstances-vaccines-emergency-use-against-bluetongue" }, { "title": "Evaluation of medicinal products for cardiovascular disease prevention - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/09/2008", "last_updated_date": "25/09/2008", "general_url": "https://www.ema.europa.eu/en/evaluation-medicinal-products-cardiovascular-disease-prevention-scientific-guideline" }, { "title": "Assessment of bioavailability of bound residues in food commodities of animal origin in the context of Council Regulation (EEC) No 2377/90 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/09/2008", "last_updated_date": "22/09/2008", "general_url": "https://www.ema.europa.eu/en/assessment-bioavailability-bound-residues-food-commodities-animal-origin-context-council-regulation-eec-no-2377-90-scientific-guideline" }, { "title": "New approach developed by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives for exposure and maximum residue limit assessment of residues of veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/09/2008", "last_updated_date": "22/09/2008", "general_url": "https://www.ema.europa.eu/en/new-approach-developed-joint-food-agriculture-organization-world-health-organization-expert-committee-food-additives-exposure-maximum-residue-limit-assessment-residues-veterinary-medicinal-products" }, { "title": "VICH GL44 Target animal safety for veterinary live and inactivated vaccines - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/09/2008", "last_updated_date": "22/09/2008", "general_url": "https://www.ema.europa.eu/en/vich-gl44-target-animal-safety-veterinary-live-inactivated-vaccines-scientific-guideline" }, { "title": "VICH GL43 Target animal safety: pharmaceuticals - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/09/2008", "last_updated_date": "22/09/2008", "general_url": "https://www.ema.europa.eu/en/vich-gl43-target-animal-safety-pharmaceuticals-scientific-guideline" }, { "title": "Development of a guideline on preparation of herbal teas - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "04/09/2008", "last_updated_date": "04/09/2008", "general_url": "https://www.ema.europa.eu/en/development-guideline-preparation-herbal-teas-scientific-guideline" }, { "title": "Clinical evaluation of medicinal products used in weight control - addendum on weight control in children - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "general_url": "https://www.ema.europa.eu/en/clinical-evaluation-medicinal-products-used-weight-control-addendum-weight-control-children-scientific-guideline" }, { "title": "Virus safety evaluation of biotechnological investigational medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "general_url": "https://www.ema.europa.eu/en/virus-safety-evaluation-biotechnological-investigational-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of immunosuppressants for solid organ transplantation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-immunosuppressants-solid-organ-transplantation-scientific-guideline" }, { "title": "Development of medicinal products for the treatment of post-traumatic stress disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "general_url": "https://www.ema.europa.eu/en/development-medicinal-products-treatment-post-traumatic-stress-disorder-scientific-guideline" }, { "title": "Quality of biological active substances produced by stable transgene expression in higher plants - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2008", "last_updated_date": "24/07/2008", "general_url": "https://www.ema.europa.eu/en/quality-biological-active-substances-produced-stable-transgene-expression-higher-plants-scientific-guideline" }, { "title": "Markers used for quantitative and qualitative analysis of herbal medicinal products and traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "15/07/2008", "last_updated_date": "15/07/2008", "general_url": "https://www.ema.europa.eu/en/markers-used-quantitative-qualitative-analysis-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "Medicinal gases: pharmaceutical documentation (including recommendation on non-clinical safety requirements for well established medicinal gases) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "09/07/2008", "last_updated_date": "09/07/2008", "general_url": "https://www.ema.europa.eu/en/medicinal-gases-pharmaceutical-documentation-including-recommendation-non-clinical-safety-requirements-well-established-medicinal-gases-scientific-guideline" }, { "title": "Quality of combination herbal medicinal products/traditional herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary;Herbal", "first_published_date": "23/06/2008", "last_updated_date": "23/06/2008", "general_url": "https://www.ema.europa.eu/en/quality-combination-herbal-medicinal-products-traditional-herbal-medicinal-products-scientific-guideline" }, { "title": "ICH Q4B Annex 2 Test for extractable volume in parenteral preparations - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2008", "last_updated_date": "01/06/2008", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-2-test-extractable-volume-parenteral-preparations-scientific-guideline" }, { "title": "ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2008", "last_updated_date": "01/06/2008", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-3-test-particulate-contamination-sub-visible-particles-scientific-guideline" }, { "title": "ICH Q10 Pharmaceutical quality system - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2008", "last_updated_date": "01/06/2008", "general_url": "https://www.ema.europa.eu/en/ich-q10-pharmaceutical-quality-system-scientific-guideline" }, { "title": "Clinical and non-clinical evaluation during the consultation procedure on medicinal substances contained in drug-eluting (medicinal-substance-eluting) coronary stents - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/05/2008", "last_updated_date": "30/05/2008", "general_url": "https://www.ema.europa.eu/en/clinical-non-clinical-evaluation-during-consultation-procedure-medicinal-substances-contained-drug-eluting-medicinal-substance-eluting-coronary-stents-scientific-guideline" }, { "title": "Human cell-based medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/05/2008", "last_updated_date": "21/05/2008", "general_url": "https://www.ema.europa.eu/en/human-cell-based-medicinal-products-scientific-guideline" }, { "title": "Adaptogenic concept - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "08/05/2008", "last_updated_date": "08/05/2008", "general_url": "https://www.ema.europa.eu/en/adaptogenic-concept-scientific-guideline" }, { "title": "ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/04/2008", "last_updated_date": "30/04/2008", "general_url": "https://www.ema.europa.eu/en/ich-s1c-r2-dose-selection-carcinogenicity-studies-pharmaceuticals-scientific-guideline" }, { "title": "Harmonisation and update of the clinical aspects in the authorised conditions of use for radiopharmaceuticals and other diagnostic medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/04/2008", "last_updated_date": "24/04/2008", "general_url": "https://www.ema.europa.eu/en/harmonisation-update-clinical-aspects-authorised-conditions-use-radiopharmaceuticals-other-diagnostic-medicinal-products-scientific-guideline" }, { "title": "Pharmacogenomics in oncology - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/04/2008", "last_updated_date": "01/04/2008", "general_url": "https://www.ema.europa.eu/en/pharmacogenomics-oncology-scientific-guideline" }, { "title": "Water for injection prepared by reverse osmosis", "summary": "", "categories": "Human;Veterinary", "first_published_date": "05/03/2008", "last_updated_date": "05/03/2008", "general_url": "https://www.ema.europa.eu/en/water-injection-prepared-reverse-osmosis" }, { "title": "Need for non-clinical testing in juvenile animals on human pharmaceuticals for paediatric indications - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "general_url": "https://www.ema.europa.eu/en/need-non-clinical-testing-juvenile-animals-human-pharmaceuticals-paediatric-indications-scientific-guideline" }, { "title": "Non-clinical development of fixed combinations of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2008", "last_updated_date": "24/01/2008", "general_url": "https://www.ema.europa.eu/en/non-clinical-development-fixed-combinations-medicinal-products-scientific-guideline" }, { "title": "Consideration of adjuvants and preservatives under Council Regulation (EEC) No 2377/90 laying down a community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/12/2007", "last_updated_date": "17/12/2007", "general_url": "https://www.ema.europa.eu/en/consideration-adjuvants-preservatives-under-council-regulation-eec-no-2377-90-laying-down-community-procedure-establishment-maximum-residue-limits-veterinary-medicinal-products-foodstuffs-animal" }, { "title": "Immunogenicity assessment of biotechnology-derived therapeutic proteins - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2007", "last_updated_date": "13/12/2007", "general_url": "https://www.ema.europa.eu/en/immunogenicity-assessment-biotechnology-derived-therapeutic-proteins-scientific-guideline" }, { "title": "Non-clinical investigation of the dependence potential of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2007", "last_updated_date": "13/12/2007", "general_url": "https://www.ema.europa.eu/en/non-clinical-investigation-dependence-potential-medicinal-products-scientific-guideline" }, { "title": "In vitro investigation of mitochondrial toxicity of anti-HIV nucleoside reverse transcriptase inhibitors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2007", "last_updated_date": "13/12/2007", "general_url": "https://www.ema.europa.eu/en/vitro-investigation-mitochondrial-toxicity-anti-hiv-nucleoside-reverse-transcriptase-inhibitors-scientific-guideline" }, { "title": "Carcinogenicity evaluation of medicinal products for the treatment of HIV infection - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2007", "last_updated_date": "13/12/2007", "general_url": "https://www.ema.europa.eu/en/carcinogenicity-evaluation-medicinal-products-treatment-hiv-infection-scientific-guideline" }, { "title": "Declaration of storage conditions for medicinal products particulars and active substances (Annex) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/11/2007", "last_updated_date": "19/11/2007", "general_url": "https://www.ema.europa.eu/en/declaration-storage-conditions-medicinal-products-particulars-active-substances-annex-scientific-guideline" }, { "title": "Use of genomics in cardiovascular clinical trials", "summary": "", "categories": "Human", "first_published_date": "15/11/2007", "last_updated_date": "15/11/2007", "general_url": "https://www.ema.europa.eu/en/use-genomics-cardiovascular-clinical-trials" }, { "title": "Pharmacogenomic samples, testing and data handling - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/11/2007", "last_updated_date": "15/11/2007", "general_url": "https://www.ema.europa.eu/en/pharmacogenomic-samples-testing-data-handling-scientific-guideline" }, { "title": "ICH Q4B Annex 1 Residue on ignition/sulphated ash - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2007", "last_updated_date": "01/11/2007", "general_url": "https://www.ema.europa.eu/en/ich-q4b-annex-1-residue-ignition-sulphated-ash-scientific-guideline" }, { "title": "ICH E15 Definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2007", "last_updated_date": "01/11/2007", "general_url": "https://www.ema.europa.eu/en/ich-e15-definitions-genomic-biomarkers-pharmacogenomics-pharmacogenetics-genomic-data-sample-coding-categories-scientific-guideline" }, { "title": "Risks associated with furocoumarins contained in preparations of Angelica archangelica L. - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "31/10/2007", "last_updated_date": "31/10/2007", "general_url": "https://www.ema.europa.eu/en/risks-associated-furocoumarins-contained-preparations-angelica-archangelica-l-scientific-guideline" }, { "title": "Methodological issues in confirmatory clinical trials planned with an adaptive design - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/10/2007", "last_updated_date": "18/10/2007", "general_url": "https://www.ema.europa.eu/en/methodological-issues-confirmatory-clinical-trials-planned-adaptive-design-scientific-guideline" }, { "title": "Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2007", "last_updated_date": "20/09/2007", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-human-anti-d-immunoglobulin-intravenous-or-intramuscular-use-scientific-guideline" }, { "title": "VICH GL41 Target animal safety: examination of live veterinary vaccines in target animals for absence of reversion to virulence - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/09/2007", "last_updated_date": "18/09/2007", "general_url": "https://www.ema.europa.eu/en/vich-gl41-target-animal-safety-examination-live-veterinary-vaccines-target-animals-absence-reversion-virulence-scientific-guideline" }, { "title": "Comparability of biotechnology-derived medicinal products after a change in the manufacturing process - non-clinical and clinical issues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/07/2007", "last_updated_date": "19/07/2007", "general_url": "https://www.ema.europa.eu/en/comparability-biotechnology-derived-medicinal-products-after-change-manufacturing-process-non-clinical-clinical-issues-scientific-guideline" }, { "title": "Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "08/07/2007", "last_updated_date": "08/07/2007", "general_url": "https://www.ema.europa.eu/en/quality-non-clinical-clinical-issues-relating-specifically-recombinant-adeno-associated-viral-vectors-scientific-guideline" }, { "title": "Reporting the results of population pharmacokinetic analyses - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/06/2007", "last_updated_date": "21/06/2007", "general_url": "https://www.ema.europa.eu/en/reporting-results-population-pharmacokinetic-analyses-scientific-guideline" }, { "title": "Excipients in the dossier for application for marketing authorisation of a medicinal product - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "19/06/2007", "last_updated_date": "19/06/2007", "general_url": "https://www.ema.europa.eu/en/excipients-dossier-application-marketing-authorisation-medicinal-product-scientific-guideline" }, { "title": "Requirements for an authorisation under exceptional circumstances for vaccines for use in birds against avian influenza", "summary": "", "categories": "Veterinary", "first_published_date": "23/04/2007", "last_updated_date": "23/04/2007", "general_url": "https://www.ema.europa.eu/en/requirements-authorisation-under-exceptional-circumstances-vaccines-use-birds-against-avian-influenza" }, { "title": "Processing joint FDA and EMA voluntary genomic data submissions within the framework of the confidentiality arrangement - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/04/2007", "last_updated_date": "01/04/2007", "general_url": "https://www.ema.europa.eu/en/processing-joint-fda-ema-voluntary-genomic-data-submissions-within-framework-confidentiality-arrangement-scientific-guideline" }, { "title": "Non-clinical studies required before first clinical use of gene therapy medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/03/2007", "last_updated_date": "22/03/2007", "general_url": "https://www.ema.europa.eu/en/non-clinical-studies-required-first-clinical-use-gene-therapy-medicinal-products-scientific-guideline" }, { "title": "Clinical trials with haematopoietic growth factors for the prophylaxis of infection following myelosuppressive or myeloablative therapy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/03/2007", "last_updated_date": "21/03/2007", "general_url": "https://www.ema.europa.eu/en/clinical-trials-haematopoietic-growth-factors-prophylaxis-infection-following-myelosuppressive-or-myeloablative-therapy-scientific-guideline" }, { "title": "VICH GL11 Impurities in new veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/02/2007", "last_updated_date": "19/02/2007", "general_url": "https://www.ema.europa.eu/en/vich-gl11-impurities-new-veterinary-medicinal-products-scientific-guideline" }, { "title": "VICH GL3 Stability testing of new veterinary drug substances and medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/02/2007", "last_updated_date": "19/02/2007", "general_url": "https://www.ema.europa.eu/en/vich-gl3-stability-testing-new-veterinary-drug-substances-medicinal-products-scientific-guideline" }, { "title": "VICH GL10 Impurities in new veterinary drug substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/02/2007", "last_updated_date": "19/02/2007", "general_url": "https://www.ema.europa.eu/en/vich-gl10-impurities-new-veterinary-drug-substances-scientific-guideline" }, { "title": "Use of (fluoro)quinolones in food-producing animals in the European Union: development of resistance and impact on human and animal health - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/02/2007", "last_updated_date": "15/02/2007", "general_url": "https://www.ema.europa.eu/en/use-fluoroquinolones-food-producing-animals-european-union-development-resistance-impact-human-animal-health-scientific-guideline" }, { "title": "Scientific requirements for the environmental risk assessment of gene-therapy medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "08/02/2007", "last_updated_date": "08/02/2007", "general_url": "https://www.ema.europa.eu/en/scientific-requirements-environmental-risk-assessment-gene-therapy-medicinal-products-scientific-guideline" }, { "title": "Superseded - Conduct of pharmacovigilance for medicines used by the paediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/01/2007", "last_updated_date": "25/01/2007", "general_url": "https://www.ema.europa.eu/en/superseded-conduct-pharmacovigilance-medicines-used-paediatric-population-scientific-guideline" }, { "title": "Clinical investigation of the pharmacokinetics of therapeutic proteins - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2007", "last_updated_date": "24/01/2007", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-pharmacokinetics-therapeutic-proteins-scientific-guideline" }, { "title": "Influenza vaccines prepared from viruses with the potential to cause a pandemic and intended for use outside of the core dossier context - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/01/2007", "last_updated_date": "24/01/2007", "general_url": "https://www.ema.europa.eu/en/influenza-vaccines-prepared-viruses-potential-cause-pandemic-intended-use-outside-core-dossier-context-scientific-guideline" }, { "title": "Thiomersal: implementation of the warning statement relating to sensitisation - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/01/2007", "last_updated_date": "11/01/2007", "general_url": "https://www.ema.europa.eu/en/thiomersal-implementation-warning-statement-relating-sensitisation-scientific-guideline" }, { "title": "Gender differences in cardiovascular diseases - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/12/2006", "last_updated_date": "14/12/2006", "general_url": "https://www.ema.europa.eu/en/gender-differences-cardiovascular-diseases-scientific-guideline" }, { "title": "Non-clinical and clinical development of medicinal products for the treatment of nausea and vomiting associated with cancer chemotherapy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/12/2006", "last_updated_date": "13/12/2006", "general_url": "https://www.ema.europa.eu/en/non-clinical-clinical-development-medicinal-products-treatment-nausea-vomiting-associated-cancer-chemotherapy-scientific-guideline" }, { "title": "Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "11/12/2006", "last_updated_date": "11/12/2006", "general_url": "https://www.ema.europa.eu/en/environmental-risk-assessments-medicinal-products-containing-or-consisting-genetically-modified-organisms-gmos-scientific-guideline" }, { "title": "Evaluation of new medicinal products in the treatment of primary osteoporosis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/11/2006", "last_updated_date": "16/11/2006", "general_url": "https://www.ema.europa.eu/en/evaluation-new-medicinal-products-treatment-primary-osteoporosis-scientific-guideline" }, { "title": "Questions and answers on the guideline on the clinical investigation of corticosteroids intended for use on the skin - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/11/2006", "last_updated_date": "16/11/2006", "general_url": "https://www.ema.europa.eu/en/questions-answers-guideline-clinical-investigation-corticosteroids-intended-use-skin-scientific-guideline" }, { "title": "ICH Considerations: general principles to address the risk of inadvertent germline integration of gene therapy vectors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2006", "last_updated_date": "01/11/2006", "general_url": "https://www.ema.europa.eu/en/ich-considerations-general-principles-address-risk-inadvertent-germline-integration-gene-therapy-vectors-scientific-guideline" }, { "title": "Use of fumigants - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "26/10/2006", "last_updated_date": "26/10/2006", "general_url": "https://www.ema.europa.eu/en/use-fumigants-scientific-guideline" }, { "title": "ICH Q3A (R2) Impurities in new drug substances - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/10/2006", "last_updated_date": "01/10/2006", "general_url": "https://www.ema.europa.eu/en/ich-q3a-r2-impurities-new-drug-substances-scientific-guideline" }, { "title": "Validation of immunoassay for the detection of hepatitis B virus surface antigen in plasma pools - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/09/2006", "last_updated_date": "21/09/2006", "general_url": "https://www.ema.europa.eu/en/validation-immunoassay-detection-hepatitis-b-virus-surface-antigen-plasma-pools-scientific-guideline" }, { "title": "Validation of immunoassay for the detection of antibody to human immunodeficiency virus in plasma pools - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/09/2006", "last_updated_date": "21/09/2006", "general_url": "https://www.ema.europa.eu/en/validation-immunoassay-detection-antibody-human-immunodeficiency-virus-plasma-pools-scientific-guideline" }, { "title": "Formulations of choice for the paediatric population - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/07/2006", "last_updated_date": "28/07/2006", "general_url": "https://www.ema.europa.eu/en/formulations-choice-paediatric-population-scientific-guideline" }, { "title": "Clinical trials in small populations - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2006", "last_updated_date": "27/07/2006", "general_url": "https://www.ema.europa.eu/en/clinical-trials-small-populations-scientific-guideline" }, { "title": "Herbal medicinal products containing cimicifugae racemosae rhizoma - serious hepatic reactions - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "18/07/2006", "last_updated_date": "18/07/2006", "general_url": "https://www.ema.europa.eu/en/herbal-medicinal-products-containing-cimicifugae-racemosae-rhizoma-serious-hepatic-reactions-scientific-guideline" }, { "title": "Impact of brain immaturity when investigating medicinal products intended for neonatal use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/06/2006", "last_updated_date": "02/06/2006", "general_url": "https://www.ema.europa.eu/en/impact-brain-immaturity-when-investigating-medicinal-products-intended-neonatal-use-scientific-guideline" }, { "title": "Clinical investigation of anti-anginal medicinal products in stable angina pectoris - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "01/06/2006", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-anti-anginal-medicinal-products-stable-angina-pectoris-scientific-guideline" }, { "title": "ICH Q1F Stability data package for registration in climatic zones III and IV - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "01/06/2006", "general_url": "https://www.ema.europa.eu/en/ich-q1f-stability-data-package-registration-climatic-zones-iii-iv-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of sepsis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "01/06/2006", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-sepsis-scientific-guideline" }, { "title": "ICH Q3B (R2) Impurities in new drug products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "01/06/2006", "general_url": "https://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products-scientific-guideline" }, { "title": "ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2006", "last_updated_date": "01/06/2006", "general_url": "https://www.ema.europa.eu/en/ich-e5r1-ethnic-factors-acceptability-foreign-clinical-data-questions-answers-scientific-guideline" }, { "title": "Potency labelling for insulin analogue containing products with particular reference to the use of \"international units\" or \"units\" - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/05/2006", "last_updated_date": "24/05/2006", "general_url": "https://www.ema.europa.eu/en/potency-labelling-insulin-analogue-containing-products-particular-reference-use-international-units-or-units-scientific-guideline" }, { "title": "Extension of the shelf life for the antigen stocks during the type II variation assessment - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "19/05/2006", "last_updated_date": "19/05/2006", "general_url": "https://www.ema.europa.eu/en/extension-shelf-life-antigen-stocks-during-type-ii-variation-assessment-scientific-guideline" }, { "title": "Pharmacogenetics briefing meeting - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/04/2006", "last_updated_date": "27/04/2006", "general_url": "https://www.ema.europa.eu/en/pharmacogenetics-briefing-meeting-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma-derived hepatitis B immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/04/2006", "last_updated_date": "27/04/2006", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-hepatitis-b-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma-derived hepatitis B immunoglobulin for intravenous use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/04/2006", "last_updated_date": "27/04/2006", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-hepatitis-b-immunoglobulin-intravenous-use-scientific-guideline" }, { "title": "Chamomilla containing herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "08/03/2006", "last_updated_date": "08/03/2006", "general_url": "https://www.ema.europa.eu/en/chamomilla-containing-herbal-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products indicated for the treatment of social anxiety - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/01/2006", "last_updated_date": "26/01/2006", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-indicated-treatment-social-anxiety-scientific-guideline" }, { "title": "Allergenic potency of herbal medicinal products containing soya or peanut protein - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "12/01/2006", "last_updated_date": "12/01/2006", "general_url": "https://www.ema.europa.eu/en/allergenic-potency-herbal-medicinal-products-containing-soya-or-peanut-protein-scientific-guideline" }, { "title": "Clinical assessment of fixed combinations of herbal substances/herbal preparations - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "11/01/2006", "last_updated_date": "11/01/2006", "general_url": "https://www.ema.europa.eu/en/clinical-assessment-fixed-combinations-herbal-substances-herbal-preparations-scientific-guideline" }, { "title": "Capsicum/capsaicin containing herbal medicinal products - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "23/11/2005", "general_url": "https://www.ema.europa.eu/en/capsicum-capsaicin-containing-herbal-medicinal-products-scientific-guideline" }, { "title": "CPMP list of herbal drugs with serious risks, dated 1992 - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "23/11/2005", "general_url": "https://www.ema.europa.eu/en/cpmp-list-herbal-drugs-serious-risks-dated-1992-scientific-guideline" }, { "title": "Use of herbal medicinal products containing methyleugenol - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "23/11/2005", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-methyleugenol-scientific-guideline" }, { "title": "Risks associated with the use of herbal products containing Aristolochia species - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "23/11/2005", "general_url": "https://www.ema.europa.eu/en/risks-associated-use-herbal-products-containing-aristolochia-species-scientific-guideline" }, { "title": "Use of herbal medicinal products containing asarone - Scientific guideline", "summary": "", "categories": "Human;Herbal", "first_published_date": "23/11/2005", "last_updated_date": "23/11/2005", "general_url": "https://www.ema.europa.eu/en/use-herbal-medicinal-products-containing-asarone-scientific-guideline" }, { "title": "Approaches on how to consider excipients in the context of Regulation 2377/90 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "22/11/2005", "last_updated_date": "22/11/2005", "general_url": "https://www.ema.europa.eu/en/approaches-how-consider-excipients-context-regulation-2377-90-scientific-guideline" }, { "title": "Impact of lung and heart immaturity when investigating medicinal products intended for neonatal use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/11/2005", "last_updated_date": "18/11/2005", "general_url": "https://www.ema.europa.eu/en/impact-lung-heart-immaturity-when-investigating-medicinal-products-intended-neonatal-use-scientific-guideline" }, { "title": "Non-clinical testing for inadvertent germline transmission of gene transfer vectors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/11/2005", "last_updated_date": "17/11/2005", "general_url": "https://www.ema.europa.eu/en/non-clinical-testing-inadvertent-germline-transmission-gene-transfer-vectors-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma derived von Willebrand factor - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/11/2005", "last_updated_date": "17/11/2005", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-von-willebrand-factor-scientific-guideline" }, { "title": "Clinical investigation of human plasma-derived von Willebrand factor products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/11/2005", "last_updated_date": "16/11/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-human-plasma-derived-von-willebrand-factor-products-scientific-guideline" }, { "title": "VICH GL39 Test procedures and acceptance criteria for new veterinary drug substances and new medicinal products: chemical substances - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/11/2005", "last_updated_date": "15/11/2005", "general_url": "https://www.ema.europa.eu/en/vich-gl39-test-procedures-acceptance-criteria-new-veterinary-drug-substances-new-medicinal-products-chemical-substances-scientific-guideline" }, { "title": "VICH GL40 Test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "15/11/2005", "last_updated_date": "15/11/2005", "general_url": "https://www.ema.europa.eu/en/vich-gl40-test-procedures-acceptance-criteria-new-biotechnological-biological-veterinary-medicinal-products-scientific-guideline" }, { "title": "Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "09/11/2005", "last_updated_date": "09/11/2005", "general_url": "https://www.ema.europa.eu/en/requirements-controls-applied-bovine-serum-used-production-immunological-veterinary-medicinal-products-scientific-guideline" }, { "title": "ICH S8 Immunotoxicity studies for human pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/10/2005", "last_updated_date": "31/10/2005", "general_url": "https://www.ema.europa.eu/en/ich-s8-immunotoxicity-studies-human-pharmaceuticals-scientific-guideline" }, { "title": "Similar biological medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/10/2005", "last_updated_date": "30/10/2005", "general_url": "https://www.ema.europa.eu/en/similar-biological-medicinal-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for hormone replacement therapy of oestrogen deficiency symptoms in postmenopausal women - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/10/2005", "last_updated_date": "13/10/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-hormone-replacement-therapy-oestrogen-deficiency-symptoms-postmenopausal-women-scientific-guideline" }, { "title": "Non-clinical documentation for mixed marketing authorisation applications - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "13/10/2005", "last_updated_date": "13/10/2005", "general_url": "https://www.ema.europa.eu/en/non-clinical-documentation-mixed-marketing-authorisation-applications-scientific-guideline" }, { "title": "Core summary of product characteristics for human tetanus immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-tetanus-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Clinical investigation of steroid contraceptives in women - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-steroid-contraceptives-women-scientific-guideline" }, { "title": "Core summary for product characteristics for human rabies immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-rabies-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Data monitoring committees - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/data-monitoring-committees-scientific-guideline" }, { "title": "Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/regulatory-guidance-use-health-related-quality-life-hrql-measures-evaluation-medicinal-products-scientific-guideline" }, { "title": "Core summary of product characteristics for human varicella immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-varicella-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Core summary of product characteristics for human tick-borne encephalitis immunoglobulin for intramuscular use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2005", "last_updated_date": "27/07/2005", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-tick-borne-encephalitis-immunoglobulin-intramuscular-use-scientific-guideline" }, { "title": "Impact of liver immaturity when investigating medicinal products intended for neonatal use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/07/2005", "last_updated_date": "20/07/2005", "general_url": "https://www.ema.europa.eu/en/impact-liver-immaturity-when-investigating-medicinal-products-intended-neonatal-use-scientific-guideline" }, { "title": "ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2005", "last_updated_date": "01/06/2005", "general_url": "https://www.ema.europa.eu/en/ich-q5e-biotechnological-biological-products-subject-changes-their-manufacturing-process-comparability-biotechnological-biological-products-scientific-guideline" }, { "title": "Development and manufacture of lentiviral vectors - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/05/2005", "last_updated_date": "26/05/2005", "general_url": "https://www.ema.europa.eu/en/development-manufacture-lentiviral-vectors-scientific-guideline" }, { "title": "Plastic primary packaging materials - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "19/05/2005", "last_updated_date": "19/05/2005", "general_url": "https://www.ema.europa.eu/en/plastic-primary-packaging-materials-scientific-guideline" }, { "title": "VICH GL28 Studies to evaluate the safety of veterinary drugs in human: carcinogenicity testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "18/05/2005", "last_updated_date": "18/05/2005", "general_url": "https://www.ema.europa.eu/en/vich-gl28-studies-evaluate-safety-veterinary-drugs-human-carcinogenicity-testing-scientific-guideline" }, { "title": "ICH M5 EWG Routes of administration controlled vocabulary - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/05/2005", "last_updated_date": "01/05/2005", "general_url": "https://www.ema.europa.eu/en/ich-m5-ewg-routes-administration-controlled-vocabulary-scientific-guideline" }, { "title": "ICH M5 EWG Units and measurements controlled vocabulary - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/05/2005", "last_updated_date": "01/05/2005", "general_url": "https://www.ema.europa.eu/en/ich-m5-ewg-units-measurements-controlled-vocabulary-scientific-guideline" }, { "title": "Requirements for vaccine antigen master file certification - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/03/2005", "last_updated_date": "17/03/2005", "general_url": "https://www.ema.europa.eu/en/requirements-vaccine-antigen-master-file-certification-scientific-guideline" }, { "title": "Evaluation of control samples for non-clinical safety studies: checking for contamination with the test substance - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/03/2005", "last_updated_date": "17/03/2005", "general_url": "https://www.ema.europa.eu/en/evaluation-control-samples-non-clinical-safety-studies-checking-contamination-test-substance-scientific-guideline" }, { "title": "Further guidance on interpretation of the data from VICH GL27 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "09/03/2005", "last_updated_date": "09/03/2005", "general_url": "https://www.ema.europa.eu/en/further-guidance-interpretation-data-vich-gl27-scientific-guideline" }, { "title": "Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/02/2005", "last_updated_date": "17/02/2005", "general_url": "https://www.ema.europa.eu/en/evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function-scientific-guideline" }, { "title": "Suitability of the graduation of delivery devices for liquid dosage forms - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2005", "last_updated_date": "01/02/2005", "general_url": "https://www.ema.europa.eu/en/suitability-graduation-delivery-devices-liquid-dosage-forms-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of obsessive compulsive disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-obsessive-compulsive-disorder-scientific-guideline" }, { "title": "Clinical investigation of medicinal products indicated for generalised anxiety disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-indicated-generalised-anxiety-disorder-scientific-guideline" }, { "title": "Assessment of the genotoxic potential of antisense oligodeoxynucleotides - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "general_url": "https://www.ema.europa.eu/en/assessment-genotoxic-potential-antisense-oligodeoxynucleotides-scientific-guideline" }, { "title": "Clinical investigation of medicinal products indicated for panic disorder - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/01/2005", "last_updated_date": "20/01/2005", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-indicated-panic-disorder-scientific-guideline" }, { "title": "VICH GL38 Environmental impact assessments for veterinary medicinal products - Phase II - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/01/2005", "last_updated_date": "01/01/2005", "general_url": "https://www.ema.europa.eu/en/vich-gl38-environmental-impact-assessments-veterinary-medicinal-products-phase-ii-scientific-guideline" }, { "title": "ICH E2E Pharmacovigilance planning (Pvp) - Scientific guideline", "summary": "This document provides guidance on planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new medicinal product. It applies to chemical entities, biotechnology-derived products and vaccines.", "categories": "Human", "first_published_date": "31/12/2004", "last_updated_date": "31/12/2004", "general_url": "https://www.ema.europa.eu/en/ich-e2e-pharmacovigilance-planning-pvp-scientific-guideline" }, { "title": "Impact of renal immaturity when investigating medicinal products intended for paediatric use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/12/2004", "last_updated_date": "16/12/2004", "general_url": "https://www.ema.europa.eu/en/impact-renal-immaturity-when-investigating-medicinal-products-intended-paediatric-use-scientific-guideline" }, { "title": "Requirements for vaccines against foot-and-mouth disease - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/12/2004", "last_updated_date": "01/12/2004", "general_url": "https://www.ema.europa.eu/en/requirements-vaccines-against-foot-mouth-disease-scientific-guideline" }, { "title": "Core summary of product characteristics for human prothrombin complex products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/11/2004", "last_updated_date": "21/11/2004", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-prothrombin-complex-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products indicated for the treatment of psoriasis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/11/2004", "last_updated_date": "18/11/2004", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-indicated-treatment-psoriasis-scientific-guideline" }, { "title": "Investigation of manufacturing processes for plasma-derived medicinal products with regard to variant Creutzfeldt-Jakob disease risk - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/10/2004", "last_updated_date": "21/10/2004", "general_url": "https://www.ema.europa.eu/en/investigation-manufacturing-processes-plasma-derived-medicinal-products-regard-variant-creutzfeldt-jakob-disease-risk-scientific-guideline" }, { "title": "Clinical development of medicinal products for the treatment of allergic rhino-conjunctivitis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/10/2004", "last_updated_date": "21/10/2004", "general_url": "https://www.ema.europa.eu/en/clinical-development-medicinal-products-treatment-allergic-rhino-conjunctivitis-scientific-guideline" }, { "title": "Clinical investigation of plasma-derived fibrin sealant/haemostatic products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/2004", "last_updated_date": "29/07/2004", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-plasma-derived-fibrin-sealant-haemostatic-products-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma coagulation factor VII products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/2004", "last_updated_date": "29/07/2004", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-coagulation-factor-vii-products-scientific-guideline" }, { "title": "First cases of BSE in USA and Canada: risk assessment of ruminant materials originating from USA and Canada - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/07/2004", "last_updated_date": "21/07/2004", "general_url": "https://www.ema.europa.eu/en/first-cases-bse-usa-canada-risk-assessment-ruminant-materials-originating-usa-canada-scientific-guideline" }, { "title": "Definition of substances capable of pharmacological action in the context of Council Directive 2001/82/EC as amended, with particular reference to excipients and manufacturing materials - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/07/2004", "last_updated_date": "01/07/2004", "general_url": "https://www.ema.europa.eu/en/definition-substances-capable-pharmacological-action-context-council-directive-2001-82-ec-amended-particular-reference-excipients-manufacturing-materials-scientific-guideline" }, { "title": "Inclusion of appendices to clinical study reports in marketing authorisation applications - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/06/2004", "last_updated_date": "23/06/2004", "general_url": "https://www.ema.europa.eu/en/inclusion-appendices-clinical-study-reports-marketing-authorisation-applications-scientific-guideline" }, { "title": "CHMP SWP conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/06/2004", "last_updated_date": "23/06/2004", "general_url": "https://www.ema.europa.eu/en/chmp-swp-conclusions-recommendations-use-genetically-modified-animal-models-carcinogenicity-assessment-scientific-guideline" }, { "title": "VICH GL31 Safety studies for veterinary drug residues in human food: repeat-dose (90) toxicity testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/06/2004", "last_updated_date": "16/06/2004", "general_url": "https://www.ema.europa.eu/en/vich-gl31-safety-studies-veterinary-drug-residues-human-food-repeat-dose-90-toxicity-testing-scientific-guideline" }, { "title": "VICH GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: developmental toxicity testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/06/2004", "last_updated_date": "16/06/2004", "general_url": "https://www.ema.europa.eu/en/vich-gl32-studies-evaluate-safety-residues-veterinary-drugs-human-food-developmental-toxicity-testing-scientific-guideline" }, { "title": "VICH GL37 Safety of veterinary drugs in human food repeat-dose (chronic) toxicity testing - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "16/06/2004", "last_updated_date": "16/06/2004", "general_url": "https://www.ema.europa.eu/en/vich-gl37-safety-veterinary-drugs-human-food-repeat-dose-chronic-toxicity-testing-scientific-guideline" }, { "title": "Development of CHMP guideline on dosing delivery of injectable liquids - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "02/06/2004", "last_updated_date": "02/06/2004", "general_url": "https://www.ema.europa.eu/en/development-chmp-guideline-dosing-delivery-injectable-liquids-scientific-guideline" }, { "title": "ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy: questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2004", "last_updated_date": "01/06/2004", "general_url": "https://www.ema.europa.eu/en/ich-m4e-common-technical-document-registration-pharmaceuticals-human-use-efficacy-questions-answers-scientific-guideline" }, { "title": "ICH M4 Common technical document for the registration of pharmaceuticals for human use: questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2004", "last_updated_date": "01/06/2004", "general_url": "https://www.ema.europa.eu/en/ich-m4-common-technical-document-registration-pharmaceuticals-human-use-questions-answers-scientific-guideline" }, { "title": "Control of impurities of pharmacopoeial substances - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/04/2004", "last_updated_date": "22/04/2004", "general_url": "https://www.ema.europa.eu/en/control-impurities-pharmacopoeial-substances-scientific-guideline" }, { "title": "Submission of marketing-authorisation applications for pandemic influenza vaccines through the centralised procedure", "summary": "", "categories": "", "first_published_date": "05/04/2004", "last_updated_date": "05/04/2004", "general_url": "https://www.ema.europa.eu/en/submission-marketing-authorisation-applications-pandemic-influenza-vaccines-through-centralised-procedure" }, { "title": "Thiomersal in vaccines for human use - recent evidence supports safety of thiomersal-containing vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/03/2004", "last_updated_date": "24/03/2004", "general_url": "https://www.ema.europa.eu/en/thiomersal-vaccines-human-use-recent-evidence-supports-safety-thiomersal-containing-vaccines-scientific-guideline" }, { "title": "Requirements for plasma master file certification - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/02/2004", "last_updated_date": "26/02/2004", "general_url": "https://www.ema.europa.eu/en/requirements-plasma-master-file-certification-scientific-guideline" }, { "title": "Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "28/01/2004", "last_updated_date": "28/01/2004", "general_url": "https://www.ema.europa.eu/en/minimising-risk-transmitting-animal-spongiform-encephalopathy-agents-human-veterinary-medicinal-products-scientific-guideline" }, { "title": "VICH GL27 Guidance on the pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "14/01/2004", "last_updated_date": "14/01/2004", "general_url": "https://www.ema.europa.eu/en/vich-gl27-guidance-pre-approval-information-registration-new-veterinary-medicinal-products-food-producing-animals-respect-antimicrobial-resistance-scientific-guideline" }, { "title": "Summary of requirements for active substances in the quality part of the dossier - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/01/2004", "last_updated_date": "01/01/2004", "general_url": "https://www.ema.europa.eu/en/summary-requirements-active-substances-quality-part-dossier-scientific-guideline" }, { "title": "Stability testing of existing active ingredients and related finished products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/2003", "last_updated_date": "17/12/2003", "general_url": "https://www.ema.europa.eu/en/stability-testing-existing-active-ingredients-related-finished-products-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for treatment of rheumatoid arthritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/2003", "last_updated_date": "17/12/2003", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-rheumatoid-arthritis-scientific-guideline" }, { "title": "Scientific data requirements for a vaccine antigen master file - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/12/2003", "last_updated_date": "15/12/2003", "general_url": "https://www.ema.europa.eu/en/scientific-data-requirements-vaccine-antigen-master-file-scientific-guideline" }, { "title": "Warning on transmissible agents in summary of product characteristics and package leaflets for plasma-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/11/2003", "last_updated_date": "26/11/2003", "general_url": "https://www.ema.europa.eu/en/warning-transmissible-agents-summary-product-characteristics-package-leaflets-plasma-derived-medicinal-products-scientific-guideline-0" }, { "title": "ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety: questions and answers - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2003", "last_updated_date": "01/11/2003", "general_url": "https://www.ema.europa.eu/en/ich-m4s-common-technical-document-registration-pharmaceuticals-human-use-safety-questions-answers-scientific-guideline" }, { "title": "Quality of water used in the production of vaccines for parenteral use - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/10/2003", "last_updated_date": "20/10/2003", "general_url": "https://www.ema.europa.eu/en/quality-water-used-production-vaccines-parenteral-use-scientific-guideline" }, { "title": "West Nile virus and plasma-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/07/2003", "last_updated_date": "25/07/2003", "general_url": "https://www.ema.europa.eu/en/west-nile-virus-plasma-derived-medicinal-products-scientific-guideline" }, { "title": "Evaluation of anticancer medicinal products - addendum on paediatric oncology - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "24/07/2003", "last_updated_date": "24/07/2003", "general_url": "https://www.ema.europa.eu/en/evaluation-anticancer-medicinal-products-addendum-paediatric-oncology-scientific-guideline" }, { "title": "ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2003", "last_updated_date": "01/07/2003", "general_url": "https://www.ema.europa.eu/en/ich-m4e-common-technical-document-registration-pharmaceuticals-human-use-efficacy-scientific-guideline" }, { "title": "ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/2003", "last_updated_date": "01/07/2003", "general_url": "https://www.ema.europa.eu/en/ich-m4s-common-technical-document-registration-pharmaceuticals-human-use-safety-scientific-guideline" }, { "title": "Clinical development of fibrinolytic medicinal products in the treatment of patients with ST -segment elevation acute myocardial infarction (STEMI) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/06/2003", "last_updated_date": "26/06/2003", "general_url": "https://www.ema.europa.eu/en/clinical-development-fibrinolytic-medicinal-products-treatment-patients-st-segment-elevation-acute-myocardial-infarction-stemi-scientific-guideline" }, { "title": "Description of composition of pegylated (conjugated) proteins in the summary of product characteristics - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/05/2003", "last_updated_date": "14/05/2003", "general_url": "https://www.ema.europa.eu/en/description-composition-pegylated-conjugated-proteins-summary-product-characteristics-scientific-guideline" }, { "title": "Development of vaccinia virus-based vaccines against smallpox - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/02/2003", "last_updated_date": "20/02/2003", "general_url": "https://www.ema.europa.eu/en/development-vaccinia-virus-based-vaccines-against-smallpox-scientific-guideline" }, { "title": "Development of live attenuated influenza vaccines", "summary": "", "categories": "", "first_published_date": "20/02/2003", "last_updated_date": "20/02/2003", "general_url": "https://www.ema.europa.eu/en/development-live-attenuated-influenza-vaccines" }, { "title": "ICH Q1A (R2) Stability testing of new drug substances and drug products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2003", "last_updated_date": "01/02/2003", "general_url": "https://www.ema.europa.eu/en/ich-q1a-r2-stability-testing-new-drug-substances-drug-products-scientific-guideline" }, { "title": "ICH Q1E Evaluation of stability data - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2003", "last_updated_date": "01/02/2003", "general_url": "https://www.ema.europa.eu/en/ich-q1e-evaluation-stability-data-scientific-guideline" }, { "title": "CVMP advisory notice to veterinary surgeons regarding the development of fibrosarcomas at sites of injection of veterinary medicinal products in cats - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/01/2003", "last_updated_date": "01/01/2003", "general_url": "https://www.ema.europa.eu/en/cvmp-advisory-notice-veterinary-surgeons-regarding-development-fibrosarcomas-sites-injection-veterinary-medicinal-products-cats-scientific-guideline" }, { "title": "Maximum in-use shelf-life for medicated drinking water - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/12/2002", "last_updated_date": "01/12/2002", "general_url": "https://www.ema.europa.eu/en/maximum-use-shelf-life-medicated-drinking-water-scientific-guideline" }, { "title": "Terminology in pharmacogenetics - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/11/2002", "last_updated_date": "21/11/2002", "general_url": "https://www.ema.europa.eu/en/terminology-pharmacogenetics-scientific-guideline" }, { "title": "Establishment of maximum residue limits for milk considering the daily intake by children - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/11/2002", "last_updated_date": "01/11/2002", "general_url": "https://www.ema.europa.eu/en/establishment-maximum-residue-limits-milk-considering-daily-intake-children-scientific-guideline" }, { "title": "Re-establishment of working seeds and working cell banks using TSE compliant materials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "10/09/2002", "last_updated_date": "10/09/2002", "general_url": "https://www.ema.europa.eu/en/re-establishment-working-seeds-working-cell-banks-using-tse-compliant-materials-scientific-guideline" }, { "title": "Re-establishment of working seeds and working cell banks using TSE compliant materials - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/09/2002", "last_updated_date": "10/09/2002", "general_url": "https://www.ema.europa.eu/en/re-establishment-working-seeds-working-cell-banks-using-tse-compliant-materials-scientific-guideline-0" }, { "title": "Regulatory requirements for the authorisation of low-dose modified-release acetyl-salicylic-acid formulations in the secondary prevention of cardiovascular events - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/07/2002", "last_updated_date": "25/07/2002", "general_url": "https://www.ema.europa.eu/en/regulatory-requirements-authorisation-low-dose-modified-release-acetyl-salicylic-acid-formulations-secondary-prevention-cardiovascular-events-scientific-guideline" }, { "title": "Carcinogenic potential - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/07/2002", "last_updated_date": "25/07/2002", "general_url": "https://www.ema.europa.eu/en/carcinogenic-potential-scientific-guideline" }, { "title": "EU requirements for batches with maximum and minimum titre or batch potency for developmental safety and efficacy studies - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "17/06/2002", "last_updated_date": "17/06/2002", "general_url": "https://www.ema.europa.eu/en/eu-requirements-batches-maximum-minimum-titre-or-batch-potency-developmental-safety-efficacy-studies-scientific-guideline" }, { "title": "Non-remunerated and remunerated donors: safety and supply of plasma-derived medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/05/2002", "last_updated_date": "30/05/2002", "general_url": "https://www.ema.europa.eu/en/non-remunerated-remunerated-donors-safety-supply-plasma-derived-medicinal-products-scientific-guideline" }, { "title": "Risk and regulatory assessment of lactose and other products prepared using calf rennet - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/05/2002", "last_updated_date": "22/05/2002", "general_url": "https://www.ema.europa.eu/en/risk-regulatory-assessment-lactose-other-products-prepared-using-calf-rennet-scientific-guideline" }, { "title": "VICH GL25 Biologicals: testing of residual formaldehyde - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/04/2002", "last_updated_date": "30/04/2002", "general_url": "https://www.ema.europa.eu/en/vich-gl25-biologicals-testing-residual-formaldehyde-scientific-guideline" }, { "title": "VICH GL26 Biologicals: testing of residual moisture - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/04/2002", "last_updated_date": "30/04/2002", "general_url": "https://www.ema.europa.eu/en/vich-gl26-biologicals-testing-residual-moisture-scientific-guideline" }, { "title": "Testing for simian virus 40 (SV40) in polio virus vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/04/2002", "last_updated_date": "25/04/2002", "general_url": "https://www.ema.europa.eu/en/testing-simian-virus-40-sv40-polio-virus-vaccines-scientific-guideline" }, { "title": "Need for assessment of reproduction toxicity of human insulin analogues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/2002", "last_updated_date": "01/03/2002", "general_url": "https://www.ema.europa.eu/en/need-assessment-reproduction-toxicity-human-insulin-analogues-scientific-guideline" }, { "title": "ICH Q1D Bracketing and matrixing designs for stability testing of drug substances and drug products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2002", "last_updated_date": "01/02/2002", "general_url": "https://www.ema.europa.eu/en/ich-q1d-bracketing-matrixing-designs-stability-testing-drug-substances-drug-products-scientific-guideline" }, { "title": "Core summary of product characteristics for human plasma derived antithrombin - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/01/2002", "last_updated_date": "17/01/2002", "general_url": "https://www.ema.europa.eu/en/core-summary-product-characteristics-human-plasma-derived-antithrombin-scientific-guideline" }, { "title": "Clinical investigation of plasma-derived antithrombin products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/01/2002", "last_updated_date": "17/01/2002", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-plasma-derived-antithrombin-products-scientific-guideline" }, { "title": "Non-clinical assessment of the carcinogenic potential of human insulin analogues - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "15/11/2001", "last_updated_date": "15/11/2001", "general_url": "https://www.ema.europa.eu/en/non-clinical-assessment-carcinogenic-potential-human-insulin-analogues-scientific-guideline" }, { "title": "Coordinating investigator signature of clinical study reports - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "18/10/2001", "last_updated_date": "18/10/2001", "general_url": "https://www.ema.europa.eu/en/coordinating-investigator-signature-clinical-study-reports-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of acute stroke - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "20/09/2001", "last_updated_date": "20/09/2001", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-acute-stroke-scientific-guideline" }, { "title": "ICH S7A Safety pharmacology studies for human pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/2000", "last_updated_date": "01/06/2001", "general_url": "https://www.ema.europa.eu/en/ich-s7a-safety-pharmacology-studies-human-pharmaceuticals-scientific-guideline" }, { "title": "Start of shelf-life of the finished dosage form (Annex to the note for guidance on the manufacture of the finished dosage form) - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "31/05/2001", "last_updated_date": "31/05/2001", "general_url": "https://www.ema.europa.eu/en/start-shelf-life-finished-dosage-form-annex-note-guidance-manufacture-finished-dosage-form-scientific-guideline" }, { "title": "Application with 1. Meta-analyses; 2. One pivotal study - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/05/2001", "last_updated_date": "31/05/2001", "general_url": "https://www.ema.europa.eu/en/application-1-meta-analyses-2-one-pivotal-study-scientific-guideline" }, { "title": "Reduction, elimination or substitution of thiomersal in vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "26/04/2001", "last_updated_date": "26/04/2001", "general_url": "https://www.ema.europa.eu/en/reduction-elimination-or-substitution-thiomersal-vaccines-scientific-guideline" }, { "title": "Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/2001", "last_updated_date": "01/03/2001", "general_url": "https://www.ema.europa.eu/en/use-tumorigenic-cells-human-origin-production-biological-biotechnological-medicinal-products-scientific-guideline" }, { "title": "In-use stability testing of human medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/2001", "last_updated_date": "01/03/2001", "general_url": "https://www.ema.europa.eu/en/use-stability-testing-human-medicinal-products-scientific-guideline" }, { "title": "Evaluation of bovine spongiform encephalopathy risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2001", "last_updated_date": "28/02/2001", "general_url": "https://www.ema.europa.eu/en/evaluation-bovine-spongiform-encephalopathy-risk-use-materials-bovine-origin-or-during-manufacture-vaccines-scientific-guideline" }, { "title": "Evaluation of bovine spongiform encephalopathies (BSE) - risk via the use of materials of bovine origin in or during the manufacture of vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/02/2001", "last_updated_date": "28/02/2001", "general_url": "https://www.ema.europa.eu/en/evaluation-bovine-spongiform-encephalopathies-bse-risk-use-materials-bovine-origin-or-during-manufacture-vaccines-scientific-guideline-0" }, { "title": "Stability and traceability requirements for vaccine intermediates - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "25/01/2001", "last_updated_date": "25/01/2001", "general_url": "https://www.ema.europa.eu/en/stability-traceability-requirements-vaccine-intermediates-scientific-guideline" }, { "title": "Risk-analysis approach for residues of VMPs in food of animal origin - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/01/2001", "last_updated_date": "01/01/2001", "general_url": "https://www.ema.europa.eu/en/risk-analysis-approach-residues-vmps-food-animal-origin-scientific-guideline" }, { "title": "ICH E10 Choice of control group in clinical trials - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/01/2001", "last_updated_date": "01/01/2001", "general_url": "https://www.ema.europa.eu/en/ich-e10-choice-control-group-clinical-trials-scientific-guideline" }, { "title": "Background to the CPMP Position Paper on possible pre-clinical studies to investigate addiction and dependence/withdrawal related to the use of selective serotonin uptake inhibitors (SSRIs) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/12/2000", "last_updated_date": "14/12/2000", "general_url": "https://www.ema.europa.eu/en/background-cpmp-position-paper-possible-pre-clinical-studies-investigate-addiction-dependence-withdrawal-related-use-selective-serotonin-uptake-inhibitors-ssris-scientific-guideline" }, { "title": "ICH Q7 Good manufacturing practice for active pharmaceutical ingredients - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/2000", "last_updated_date": "01/11/2000", "general_url": "https://www.ema.europa.eu/en/ich-q7-good-manufacturing-practice-active-pharmaceutical-ingredients-scientific-guideline" }, { "title": "Pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "27/07/2000", "last_updated_date": "27/07/2000", "general_url": "https://www.ema.europa.eu/en/pharmacokinetics-pharmacodynamics-development-antibacterial-medicinal-products-scientific-guideline" }, { "title": "VICH GL6 Environmental impact assessment (EIAS) for veterinary medicinal products - Phase I - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "30/06/2000", "last_updated_date": "20/07/2000", "general_url": "https://www.ema.europa.eu/en/vich-gl6-environmental-impact-assessment-eias-veterinary-medicinal-products-phase-i-scientific-guideline" }, { "title": "VICH GL9 Good clinical practices - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "04/07/2000", "last_updated_date": "04/07/2000", "general_url": "https://www.ema.europa.eu/en/vich-gl9-good-clinical-practices-scientific-guideline" }, { "title": "Maximum shelf-life for sterile medicinal products after first opening or following reconstitution - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/07/2000", "last_updated_date": "01/07/2000", "general_url": "https://www.ema.europa.eu/en/maximum-shelf-life-sterile-medicinal-products-after-first-opening-or-following-reconstitution-scientific-guideline" }, { "title": "ICH E12 Principles for clinical evaluation of new antihypertensive drugs - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/2000", "last_updated_date": "01/06/2000", "general_url": "https://www.ema.europa.eu/en/ich-e12-principles-clinical-evaluation-new-antihypertensive-drugs-scientific-guideline" }, { "title": "VICH GL17 Stability testing of biotechnological/biological veterinary medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/06/2000", "last_updated_date": "01/06/2000", "general_url": "https://www.ema.europa.eu/en/vich-gl17-stability-testing-biotechnological-biological-veterinary-medicinal-products-scientific-guideline" }, { "title": "VICH GL4 Stability testing for new veterinary dosage forms - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/05/2000", "last_updated_date": "25/05/2000", "general_url": "https://www.ema.europa.eu/en/vich-gl4-stability-testing-new-veterinary-dosage-forms-scientific-guideline" }, { "title": "VICH GL5 Stability testing: photostability testing of new veterinary drug substances and medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "25/05/2000", "last_updated_date": "25/05/2000", "general_url": "https://www.ema.europa.eu/en/vich-gl5-stability-testing-photostability-testing-new-veterinary-drug-substances-medicinal-products-scientific-guideline" }, { "title": "Background to the CPMP Position Paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "12/04/2000", "last_updated_date": "12/04/2000", "general_url": "https://www.ema.europa.eu/en/background-cpmp-position-paper-selective-serotonin-uptake-inhibitors-ssris-dependency-withdrawal-reactions-scientific-guideline" }, { "title": "Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/02/2000", "last_updated_date": "01/02/2000", "general_url": "https://www.ema.europa.eu/en/endpoints-clinical-studies-haematopoietic-growth-factors-mobilisation-autologous-stem-cells-scientific-guideline" }, { "title": "Clinical investigation of medicinal products for the treatment of venous thromboembolic disease - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "16/12/1999", "last_updated_date": "16/12/1999", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-treatment-venous-thromboembolic-disease-scientific-guideline" }, { "title": "ICH Q6A specifications: test procedures and acceptance criteria for new drug substances and new drug products: chemical substances - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/1999", "last_updated_date": "01/11/1999", "general_url": "https://www.ema.europa.eu/en/ich-q6a-specifications-test-procedures-acceptance-criteria-new-drug-substances-new-drug-products-chemical-substances-scientific-guideline" }, { "title": "Polysorbate 80 - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "22/10/1999", "last_updated_date": "22/10/1999", "general_url": "https://www.ema.europa.eu/en/polysorbate-80-scientific-guideline" }, { "title": "Development pharmaceutics for biotechnological and biological products (Annex to note for guidance on development pharmaceutics) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "21/10/1999", "last_updated_date": "21/10/1999", "general_url": "https://www.ema.europa.eu/en/development-pharmaceutics-biotechnological-biological-products-annex-note-guidance-development-pharmaceutics-scientific-guideline" }, { "title": "Wording of Helicobacter pylori eradication therapy in selected summary-of-product-characteristics sections - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/09/1999", "last_updated_date": "23/09/1999", "general_url": "https://www.ema.europa.eu/en/wording-helicobacter-pylori-eradication-therapy-selected-summary-product-characteristics-sections-scientific-guideline" }, { "title": "ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/09/1999", "last_updated_date": "01/09/1999", "general_url": "https://www.ema.europa.eu/en/ich-q6b-specifications-test-procedures-acceptance-criteria-biotechnological-biological-products-scientific-guideline" }, { "title": "Plasma-derived medicinal products: ALT testing - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/1999", "last_updated_date": "29/07/1999", "general_url": "https://www.ema.europa.eu/en/plasma-derived-medicinal-products-alt-testing-scientific-guideline" }, { "title": "Cell culture inactivated influenza vaccines (Annex to note for guidance on harmonisation of requirements for influenza vaccines)", "summary": "", "categories": "", "first_published_date": "29/07/1999", "last_updated_date": "29/07/1999", "general_url": "https://www.ema.europa.eu/en/cell-culture-inactivated-influenza-vaccines-annex-note-guidance-harmonisation-requirements-influenza-vaccines" }, { "title": "Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza vaccines - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "29/07/1999", "last_updated_date": "29/07/1999", "general_url": "https://www.ema.europa.eu/en/explanatory-note-withdrawal-note-guidance-harmonisation-requirements-influenza-vaccines-scientific-guideline" }, { "title": "Compliance of veterinary vaccines under the centralised procedure with veterinary vaccine monographs of the European Pharmacopoeia - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/06/1999", "last_updated_date": "01/06/1999", "general_url": "https://www.ema.europa.eu/en/compliance-veterinary-vaccines-under-centralised-procedure-veterinary-vaccine-monographs-european-pharmacopoeia-scientific-guideline" }, { "title": "VICH GL1 Validation of analytical procedures: definition and terminology - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1998", "last_updated_date": "10/12/1998", "general_url": "https://www.ema.europa.eu/en/vich-gl1-validation-analytical-procedures-definition-terminology-scientific-guideline" }, { "title": "VICH GL2 Validation of analytical procedures: methodology - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "10/12/1998", "last_updated_date": "10/12/1998", "general_url": "https://www.ema.europa.eu/en/vich-gl2-validation-analytical-procedures-methodology-scientific-guideline" }, { "title": "ICH S4 Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/1998", "last_updated_date": "30/11/1998", "general_url": "https://www.ema.europa.eu/en/ich-s4-duration-chronic-toxicity-testing-animals-rodent-non-rodent-toxicity-testing-scientific-guideline" }, { "title": "ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/09/1998", "last_updated_date": "01/09/1998", "general_url": "https://www.ema.europa.eu/en/ich-e5-r1-ethnic-factors-acceptability-foreign-clinical-data-scientific-guideline" }, { "title": "Batch potency testing of immunological veterinary medicinal product - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/09/1998", "last_updated_date": "01/09/1998", "general_url": "https://www.ema.europa.eu/en/batch-potency-testing-immunological-veterinary-medicinal-product-scientific-guideline" }, { "title": "Premixes for medicated feeding stuffs for veterinary use versus powders/granules for oral use or use in drinking water - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/08/1998", "last_updated_date": "01/08/1998", "general_url": "https://www.ema.europa.eu/en/premixes-medicated-feeding-stuffs-veterinary-use-versus-powders-granules-oral-use-or-use-drinking-water-scientific-guideline" }, { "title": "Development pharmaceutics - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/07/1998", "last_updated_date": "28/07/1998", "general_url": "https://www.ema.europa.eu/en/development-pharmaceutics-scientific-guideline" }, { "title": "Clinical investigation of medicinal products used in the treatment of osteoarthritis - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "23/07/1998", "last_updated_date": "23/07/1998", "general_url": "https://www.ema.europa.eu/en/clinical-investigation-medicinal-products-used-treatment-osteoarthritis-scientific-guideline" }, { "title": "Viral safety of oral poliovirus vaccine (OPV) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/05/1998", "last_updated_date": "28/05/1998", "general_url": "https://www.ema.europa.eu/en/viral-safety-oral-poliovirus-vaccine-opv-scientific-guideline" }, { "title": "ICH Q5D Derivation and characterisation of cell substrates used for production of biotechnological/biological products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/03/1998", "last_updated_date": "31/03/1998", "general_url": "https://www.ema.europa.eu/en/ich-q5d-derivation-characterisation-cell-substrates-used-production-biotechnological-biological-products-scientific-guideline" }, { "title": "Definition of a new biological active substance in terms of active, passive immunity and immunomodulators which then constitute a new active ingredient in the context of part B of the Annex to Council Regulation (EEC) No 2309/93 - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/02/1998", "last_updated_date": "01/02/1998", "general_url": "https://www.ema.europa.eu/en/definition-new-biological-active-substance-terms-active-passive-immunity-immunomodulators-which-then-constitute-new-active-ingredient-context-part-b-annex-council-regulation-eec-no-2309-93-scientific" }, { "title": "Maximum shelf-life for sterile products for human use after first opening or following reconstitution - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "28/01/1998", "last_updated_date": "28/01/1998", "general_url": "https://www.ema.europa.eu/en/maximum-shelf-life-sterile-products-human-use-after-first-opening-or-following-reconstitution-scientific-guideline" }, { "title": "Establishment of maximum residue limits for Salmonidae and other fin fish - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/01/1998", "last_updated_date": "01/01/1998", "general_url": "https://www.ema.europa.eu/en/establishment-maximum-residue-limits-salmonidae-other-fin-fish-scientific-guideline" }, { "title": "ICH Q1C Stability testing: requirements for new dosage forms - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/01/1998", "last_updated_date": "01/01/1998", "general_url": "https://www.ema.europa.eu/en/ich-q1c-stability-testing-requirements-new-dosage-forms-scientific-guideline" }, { "title": "Genotoxic and carcinogenic potential of phenolphthalein - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/1997", "last_updated_date": "17/12/1997", "general_url": "https://www.ema.europa.eu/en/genotoxic-carcinogenic-potential-phenolphthalein-scientific-guideline" }, { "title": "Production of tallow derivatives for use in pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "17/12/1997", "last_updated_date": "17/12/1997", "general_url": "https://www.ema.europa.eu/en/production-tallow-derivatives-use-pharmaceuticals-scientific-guideline" }, { "title": "ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/09/1997", "last_updated_date": "30/09/1997", "general_url": "https://www.ema.europa.eu/en/ich-s6-r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals-scientific-guideline" }, { "title": "Inclusion of antioxidants and antimicrobial preservatives in medicinal products - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "07/07/1997", "last_updated_date": "07/07/1997", "general_url": "https://www.ema.europa.eu/en/inclusion-antioxidants-antimicrobial-preservatives-medicinal-products-scientific-guideline" }, { "title": "Harmonisation of requirements for influenza vaccines", "summary": "", "categories": "", "first_published_date": "12/03/1997", "last_updated_date": "12/03/1997", "general_url": "https://www.ema.europa.eu/en/harmonisation-requirements-influenza-vaccines" }, { "title": "ICH Q1B Photostability testing of new active substances and medicinal products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/1996", "last_updated_date": "01/12/1996", "general_url": "https://www.ema.europa.eu/en/ich-q1b-photostability-testing-new-active-substances-medicinal-products-scientific-guideline" }, { "title": "ICH E3 Structure and content of clinical study reports - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/1996", "last_updated_date": "01/07/1996", "general_url": "https://www.ema.europa.eu/en/ich-e3-structure-content-clinical-study-reports-scientific-guideline" }, { "title": "ICH Q5C Stability testing of biotechnological/biological products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/1996", "last_updated_date": "01/07/1996", "general_url": "https://www.ema.europa.eu/en/ich-q5c-stability-testing-biotechnological-biological-products-scientific-guideline" }, { "title": "ICH Q5B Analysis of the expression construct in cell lines used for production of rDNA-derived protein products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/07/1996", "last_updated_date": "01/07/1996", "general_url": "https://www.ema.europa.eu/en/ich-q5b-analysis-expression-construct-cell-lines-used-production-rdna-derived-protein-products-scientific-guideline" }, { "title": "Virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "14/02/1996", "last_updated_date": "14/02/1996", "general_url": "https://www.ema.europa.eu/en/virus-validation-studies-design-contribution-interpretation-studies-validating-inactivation-removal-viruses-scientific-guideline" }, { "title": "Post-marketing surveillance studies for metered dose inhalers with new propellant - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/12/1995", "last_updated_date": "30/12/1995", "general_url": "https://www.ema.europa.eu/en/post-marketing-surveillance-studies-metered-dose-inhalers-new-propellant-scientific-guideline" }, { "title": "ICH S1A Need for carcinogenicity studies of pharmaceuticals - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/1995", "last_updated_date": "01/12/1995", "general_url": "https://www.ema.europa.eu/en/ich-s1a-need-carcinogenicity-studies-pharmaceuticals-scientific-guideline" }, { "title": "Antiarrhythmics - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/1995", "last_updated_date": "01/11/1995", "general_url": "https://www.ema.europa.eu/en/antiarrhythmics-scientific-guideline" }, { "title": "ICH E1 Population exposure: the extent of population exposure to assess clinical safety - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/06/1995", "last_updated_date": "01/06/1995", "general_url": "https://www.ema.europa.eu/en/ich-e1-population-exposure-extent-population-exposure-assess-clinical-safety-scientific-guideline" }, { "title": "ICH E2A Clinical safety data management: definitions and standards for expedited reporting - Scientific guideline", "summary": "This document aims to develop standard definitions and terminology for key aspects of clinical safety reporting. I also provides guidance on the appropriate mechanism for handling expedited (rapid) reporting, in the investigational (i.e. pre-approval) phase.", "categories": "Human", "first_published_date": "01/06/1995", "last_updated_date": "01/06/1995", "general_url": "https://www.ema.europa.eu/en/ich-e2a-clinical-safety-data-management-definitions-standards-expedited-reporting-scientific-guideline" }, { "title": "Production and quality control of medicinal products derived by recombinant DNA technology - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/12/1994", "last_updated_date": "31/12/1994", "general_url": "https://www.ema.europa.eu/en/production-quality-control-medicinal-products-derived-recombinant-dna-technology-scientific-guideline" }, { "title": "Gene therapy product quality aspects in the production of vectors and genetically modified somatic cells - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "31/12/1994", "last_updated_date": "31/12/1994", "general_url": "https://www.ema.europa.eu/en/gene-therapy-product-quality-aspects-production-vectors-genetically-modified-somatic-cells-scientific-guideline" }, { "title": "ICH S3B Pharmacokinetics: repeated dose tissue distribution studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/1994", "last_updated_date": "30/11/1994", "general_url": "https://www.ema.europa.eu/en/ich-s3b-pharmacokinetics-repeated-dose-tissue-distribution-studies-scientific-guideline" }, { "title": "ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "30/11/1994", "last_updated_date": "30/11/1994", "general_url": "https://www.ema.europa.eu/en/ich-s3a-toxicokinetics-assessment-systemic-exposure-toxicity-studies-scientific-guideline" }, { "title": "ICH E4 Dose response information to support drug registration - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/11/1994", "last_updated_date": "01/11/1994", "general_url": "https://www.ema.europa.eu/en/ich-e4-dose-response-information-support-drug-registration-scientific-guideline" }, { "title": "ICH E7 Studies in support of special populations: geriatrics - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/03/1994", "last_updated_date": "01/03/1994", "general_url": "https://www.ema.europa.eu/en/ich-e7-studies-support-special-populations-geriatrics-scientific-guideline" }, { "title": "Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/12/1993", "last_updated_date": "01/12/1993", "general_url": "https://www.ema.europa.eu/en/replacement-chlorofluorocarbons-cfc-metered-dose-inhalation-products-scientific-guideline" }, { "title": "Investigation of chiral active substances (human) - Scientific guideline", "summary": "", "categories": "Human", "first_published_date": "01/10/1993", "last_updated_date": "01/10/1993", "general_url": "https://www.ema.europa.eu/en/investigation-chiral-active-substances-human-scientific-guideline" }, { "title": "Investigation of chiral active substances (veterinary) - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/10/1993", "last_updated_date": "01/10/1993", "general_url": "https://www.ema.europa.eu/en/investigation-chiral-active-substances-veterinary-scientific-guideline" }, { "title": "Local tolerance of intramammary preparations in cows - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/11/1992", "last_updated_date": "01/11/1992", "general_url": "https://www.ema.europa.eu/en/local-tolerance-intramammary-preparations-cows-scientific-guideline" }, { "title": "Use of ionizing radiation in the manufacture of medicinal products - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/12/1991", "last_updated_date": "01/12/1991", "general_url": "https://www.ema.europa.eu/en/use-ionizing-radiation-manufacture-medicinal-products-scientific-guideline" }, { "title": "Specifications and control tests on the finished product - Scientific guideline", "summary": "", "categories": "Human;Veterinary", "first_published_date": "01/12/1991", "last_updated_date": "01/12/1991", "general_url": "https://www.ema.europa.eu/en/specifications-control-tests-finished-product-scientific-guideline" }, { "title": "Performance enhancers - Scientific guideline", "summary": "", "categories": "Veterinary", "first_published_date": "01/05/1991", "last_updated_date": "01/05/1991", "general_url": "https://www.ema.europa.eu/en/performance-enhancers-scientific-guideline" } ] }