{ "meta": { "total_records": 1065, "timestamp": "2026-09-29T18:06:06Z" }, "data": [ { "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": "29/09/2026", "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": "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": "29/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues" }, { "title": "Outcomes of imposed non-interventional post-authorisation safety studies", "summary": "", "categories": "Human", "first_published_date": "23/02/2017", "last_updated_date": "29/09/2026", "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": "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": "29/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/website-outages-upgrades" }, { "title": "Scientific guidelines", "summary": "The European Medicines Agency (EMA) publishes scientific guidelines for human and veterinary medicines, as well as for herbal medicinal products. Scientific guidelines reflect a harmonised approach of the EU Member States and EMA on how to interpret and apply EU requirements for quality, safety and efficacy. Guidelines also help prepare marketing authorisation applications.", "categories": "Human;Veterinary;Herbal", "first_published_date": "29/09/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/scientific-guidelines" }, { "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": "29/09/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines" }, { "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": "28/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/reform-eu-pharmaceutical-legislation" }, { "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": "28/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals" }, { "title": "Questions and answers for biological medicinal products", "summary": "", "categories": "Human", "first_published_date": "18/09/2023", "last_updated_date": "25/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guidelines/questions-answers-biological-medicinal-products" }, { "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", "first_published_date": "15/02/2019", "last_updated_date": "25/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources" }, { "title": "Enpr-EMA priority activities", "summary": "The aim of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) is to facilitate studies in order to increase the availability of medicines for children. It works by holding annual workshops to define priority tasks and setting up working groups to carry out specific activities.", "categories": "Human", "first_published_date": "25/07/2019", "last_updated_date": "24/09/2026", "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": "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": "22/09/2026", "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": "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": "22/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/assessment-templates-guidance" }, { "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": "21/09/2026", "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": "Veterinary good pharmacovigilance practices (VGVP)", "summary": "Veterinary good pharmacovigilance practices (VGVP) are a set of measures to facilitate pharmacovigilance for veterinary medicines in the European Union (EU) / European Economic Area (EEA). They apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "18/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/veterinary-good-pharmacovigilance-practices-vgvp" }, { "title": "Quality: post approval change management protocols", "summary": "", "categories": "Veterinary", "first_published_date": "13/04/2012", "last_updated_date": "18/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/research-development-veterinary-medicines/scientific-guidelines-veterinary-medicines/quality-guidelines/quality-post-approval-change-management-protocols" }, { "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": "16/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/product-information-requirements/electronic-product-information-epi" }, { "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": "16/09/2026", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/scientific-publications" }, { "title": "International collaboration on GMP inspections", "summary": "The European Medicines Agency (EMA) participates in initiatives with partner organisations outside the European Union (EU) on good manufacturing practice (GMP) inspections.", "categories": "Human", "first_published_date": "28/09/2017", "last_updated_date": "14/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/international-collaboration-gmp-inspections" }, { "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": "09/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-orphan-medical-devices" }, { "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": "09/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/high-risk-medical-devices/scientific-advice-high-risk-medical-devices" }, { "title": "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": "09/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp" }, { "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": "07/09/2026", "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": "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": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/signal-management-veterinary-medicines" }, { "title": "Pharmacogenomics", "summary": "Information on pharmacogenomics, including pharmacogenomic information in centrally authorised medicines and scientific guidelines for medicine developers.", "categories": "", "first_published_date": "04/09/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacogenomics" }, { "title": "Union Product Database: release notes", "summary": "", "categories": "Veterinary", "first_published_date": "21/10/2020", "last_updated_date": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/union-product-database/union-product-database-release-notes" }, { "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": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines" }, { "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": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance" }, { "title": "Framework for interaction with pharmaceutical industry stakeholders", "summary": "The framework for interaction with industry stakeholders formalises and structures interactions with pharmaceutical industry associations active in the human and veterinary medicines.", "categories": "Corporate", "first_published_date": "31/12/2009", "last_updated_date": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-industry/framework-interaction-pharmaceutical-industry-stakeholders" }, { "title": "Pharmaceutical industry: Getting involved in EMA activities", "summary": "Information on the criteria that not-for-profit industry organisations must meet to be eligible for involvement in EMA activities, how to apply, and the list of eligible organisations", "categories": "Corporate", "first_published_date": "04/09/2026", "last_updated_date": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/pharmaceutical-industry/pharmaceutical-industry-getting-involved-ema-activities" }, { "title": "Women's health", "summary": "The European Medicines Agency (EMA) works to ensure that the needs of women are considered throughout the development, evaluation and use of medicines in the European Union (EU). This includes promoting appropriate representation in clinical research, providing guidance to medicine developers, improving knowledge on medicine use during pregnancy and breastfeeding, and generating real world evidence on women's health.", "categories": "Human", "first_published_date": "02/09/2026", "last_updated_date": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/womens-health" }, { "title": "Scientific and technical recommendations: Veterinary Medicines Regulation", "summary": "The European Medicines Agency (EMA) prepared 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 provided these recommendations at the request of the European Commission.", "categories": "Veterinary", "first_published_date": "23/09/2019", "last_updated_date": "04/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/veterinary-medicinal-products-regulation/scientific-technical-recommendations-veterinary-medicines-regulation" }, { "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": "03/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/support-smes" }, { "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": "03/09/2026", "general_url": "https://www.ema.europa.eu/en/news-events/podcast-inside-ema" }, { "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": "02/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/plasma-master-file-pmf-certification/plasma-master-file-certificates" }, { "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": "02/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance" }, { "title": "Pre-submission interactions model pilot", "summary": "The European Medicines Agency (EMA) is running a voluntary pilot assessing a revised model for pre-submission interactions for initial marketing authorisation applications.", "categories": "Human", "first_published_date": "02/09/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance/pre-submission-interactions-model-pilot" }, { "title": "Assessment templates and guidance (veterinary medicines)", "summary": "The rapporteurs of the Committee for Veterinary Medicinal Products (CVMP) should use the templates and documents provided on this page for the assessment of any new marketing authorisation application for a veterinary medicine under the centralised procedure. For initial marketing authorisation applications, this includes a version of the list of questions and the scientific overview.", "categories": "Veterinary", "first_published_date": "10/03/2022", "last_updated_date": "02/09/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines/assessment-templates-guidance-veterinary-medicines" }, { "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": "01/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/portfolio-technology-meetings" }, { "title": "Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing", "summary": "New approach methodologies (NAMs) are innovative methods or testing approaches aimed to progressively replace, reduce and refine ('3Rs' principles) traditional animal studies. The European Medicines Agency (EMA) supports the regulatory acceptance of NAMs across the European Union (EU). 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": "01/09/2026", "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": "New approach methodologies to replace and reduce animal testing: Voluntary data submission pilot", "summary": "The European Medicines Agency (EMA) is running a pilot to facilitate sharing data generated via so-called new approach methodologies aimed at replacing, reducing and refining traditional animal testing in the non-clinical development of medicines.", "categories": "Human;Veterinary", "first_published_date": "01/09/2026", "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/new-approach-methodologies-replace-reduce-animal-testing-voluntary-data-submission-pilot" }, { "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": "01/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/task-forces" }, { "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": "01/09/2026", "general_url": "https://www.ema.europa.eu/en/about-us/who-we-are/veterinary-medicines" }, { "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": "01/09/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices/expert-panel-support-breakthrough-medical-devices-pilot-programme" }, { "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": "28/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/how-pay" }, { "title": "Tackling antimicrobial resistance: Information for animal health practitioners", "summary": "Information for veterinarians on tackling antimicrobial resistance, including restrictions on the use of certain antimicrobials in animals in the EU", "categories": "Veterinary", "first_published_date": "08/04/2025", "last_updated_date": "27/08/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/animal-health-professionals/tackling-antimicrobial-resistance-information-animal-health-practitioners" }, { "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": "26/08/2026", "general_url": "https://www.ema.europa.eu/en/medicines/medicines-human-use-under-evaluation" }, { "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": "19/08/2026", "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": "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": "19/08/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/marketing-authorisation-veterinary-medicines" }, { "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": "18/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/accessibility" }, { "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": "18/08/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmra" }, { "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": "14/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/artificial-intelligence" }, { "title": "Reliance for post-authorisation changes pilots", "summary": "EMA is testing a global model for post-authorisation changes with national regulatory authorities outside the EU, the World Health Organization (WHO) and the pharmaceutical industry. The programme enables authorities to use EMA's assessments to inform national decision-making and facilitate patient access to quality-assured medicines. This approach is based on the principle of reliance.", "categories": "Corporate", "first_published_date": "28/02/2025", "last_updated_date": "13/08/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-applied-post-autorisation-changes-pilots-pharmaceutical-industry" }, { "title": "Reliance for post-authorisation changes: guidance for the pharmaceutical industry", "summary": "EMA makes available guidance on how pharmaceutical companies can apply to a pilot programme that enables them to use reliance to submit post-authorisation changes simultaneously to multiple countries outside the European Union.", "categories": "Human", "first_published_date": "13/08/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/reliance-post-authorisation-changes-guidance-pharmaceutical-industry" }, { "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": "12/08/2026", "general_url": "https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when" }, { "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": "12/08/2026", "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": "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": "12/08/2026", "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": "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": "11/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-veterinary-medicines" }, { "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": "11/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-human-medicines" }, { "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": "10/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/vaccine-monitoring-platform" }, { "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": "10/08/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/prime-priority-medicines" }, { "title": "Reporting adverse events for veterinary medicines", "summary": "Information on reporting adverse events related to veterinary medicines in the European Union (EU)", "categories": "Veterinary", "first_published_date": "08/04/2025", "last_updated_date": "08/08/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/animal-health-professionals/reporting-adverse-events-veterinary-medicines" }, { "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": "07/08/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/medicine-shortages-availability-issues/medicine-shortages-availability-issues-guidance-companies" }, { "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": "06/08/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/fees-payable-european-medicines-agency-guidance-all-applicants" }, { "title": "United for health at WorldPride 2026", "summary": "The European Medicines Agency (EMA) celebrated diversity, equality and inclusion in public health during Amsterdam's World Pride Canal Parade.", "categories": "Corporate", "first_published_date": "04/08/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/news-events/ema-campaigns/united-health-worldpride-2026" }, { "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": "29/07/2026", "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": "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": "24/07/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp-working-parties-other-groups/healthcare-professionals-working-party" }, { "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": "22/07/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/academia" }, { "title": "Horizon scanning: Identifying emerging trends", "summary": "The EU Innovation Network (EU IN) of the European medicines regulatory network is conducting horizon scanning to identify emerging science, technologies and trends that may shape the future of human medicines.", "categories": "Human", "first_published_date": "17/07/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/eu-innovation-network-eu/horizon-scanning-identifying-emerging-trends" }, { "title": "CVMP: meeting archive 2019-2020", "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 2019 to 2020.", "categories": "Veterinary", "first_published_date": "16/07/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/cvmp-meeting-archive-2019-2020" }, { "title": "PRAC: meeting archive 2018-2020", "summary": "This is an archive of the meeting highlights, agendas and minutes from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) in 2018 to 2020.", "categories": "Human", "first_published_date": "16/07/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/prac-meeting-archive-2018-2020" }, { "title": "Questions and answers: Article 13 referral procedures", "summary": "This page lists questions that stakeholders, particularly marketing authorisation holders (MAHs)/applicants, may have on Article 13 referral procedures.", "categories": "Human;Veterinary", "first_published_date": "06/07/2016", "last_updated_date": "16/07/2026", "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": "This page lists questions that stakeholders, particularly marketing authorisation holders (MAHs)/applicants, may have on Article 29(4) referral procedures.", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "16/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/referral-procedures-human-medicines/questions-answers-article-294-referral-procedures" }, { "title": "CHMP: meeting archive 2019-2020", "summary": "This is an archive of the meeting highlights, agendas and minutes from the Committee for Medicinal Products for Human Use (CHMP) in 2019 to 2020.", "categories": "Human", "first_published_date": "16/07/2026", "last_updated_date": "", "general_url": "https://www.ema.europa.eu/en/chmp-meeting-archive-2019-2020" }, { "title": "Questions and answers: Article 30 referral procedures", "summary": "This page lists questions that stakeholders, particularly marketing authorisation holders (MAHs), may have on Article 30 referral procedures.", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "15/07/2026", "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 31 non-pharmacovigilance referrals", "summary": "This page lists questions that stakeholders, particularly marketing authorisation holders (MAHs)/applicants, may have on an Article 31 non-pharmacovigilance referral procedure.", "categories": "Human", "first_published_date": "06/07/2016", "last_updated_date": "15/07/2026", "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": "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": "15/07/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/chmp/quality-working-party" }, { "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": "15/07/2026", "general_url": "https://www.ema.europa.eu/en/committees/working-parties-other-groups/eu-innovation-network-eu" }, { "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": "14/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-labelling-package-leaflet-article-613-notifications" }, { "title": "Open letters", "summary": "", "categories": "Corporate", "first_published_date": "15/07/2016", "last_updated_date": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/news-and-events/publications/open-letters" }, { "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": "Corporate", "first_published_date": "24/09/2018", "last_updated_date": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/remote-connection-ema-it-systems" }, { "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/grouping-variations-questions-answers" }, { "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answers" }, { "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": "13/07/2026", "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": "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass" }, { "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/extensions-marketing-authorisations-questions-answers" }, { "title": "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/worksharing-questions-answers" }, { "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ib-variations-questions-answers" }, { "title": "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": "13/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ii-variations-questions-answers" }, { "title": "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": "10/07/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/antimicrobial-resistance-veterinary-medicine" }, { "title": "International arrangements", "summary": "The European Medicines Agency (EMA) cooperates with a number of countries and organisations outside the European Union (EU) based on specific types of arrangements. These arrangements enable the signatories to share information or facilitate market access and achieve greater international harmonisation while protecting consumer safety.", "categories": "", "first_published_date": "28/09/2017", "last_updated_date": "08/07/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/international-arrangements" }, { "title": "New Zealand", "summary": "The European Commission's Directorate-General for Health and Food Safety (DG-SANTE) and EMA have in place a working arrangement with the New Zealand Ministry of Health since 2026. The Ministry of Health incorporates the New Zealand Medicines and Medical Devices Safety Authority, Medsafe.", "categories": "Corporate", "first_published_date": "28/09/2017", "last_updated_date": "08/07/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/bilateral-interactions-non-eu-regulators/new-zealand" }, { "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": "07/07/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/qualification-novel-methodologies-medicine-development" }, { "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": "03/07/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/variations-requiring-assessment-veterinary-medicines" }, { "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": "03/07/2026", "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": "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": "30/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/governance-reporting/financial-management-budgetary-reporting" }, { "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": "29/06/2026", "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": "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": "29/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/annual-reports-work-programmes" }, { "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": "24/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/about-website/cookies" }, { "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": "22/06/2026", "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": "How to recognise scams and phishing using EMA credentials", "summary": "The European Medicines Agency (EMA) is aware of cases where fraudulent third parties using EMA’s credentials approach citizens to request money or send phishing emails that appear to come from EMA but in fact contain malicious links or attachments.", "categories": "Corporate", "first_published_date": "20/02/2025", "last_updated_date": "18/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-recognise-scams-phishing-using-ema-credentials" }, { "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": "17/06/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/one-health-approach" }, { "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": "17/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/data-protection-privacy-ema/central-register-data-processing-records" }, { "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": "16/06/2026", "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": "16/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/frequently-asked-questions" }, { "title": "Notifying EMA of changes to contact persons (veterinary medicines)", "summary": "Applicants and marketing authorisation holders for veterinary medicines must notify the European Medicines Agency (EMA) of any upcoming changes to contact persons specified in the application form for initial marketing authorisation.", "categories": "Veterinary", "first_published_date": "31/12/2009", "last_updated_date": "15/06/2026", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/notifying-ema-changes-contact-persons-veterinary-medicines" }, { "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": "15/06/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/contacting-ema-post-authorisation" }, { "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": "12/06/2026", "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": "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": "12/06/2026", "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": "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": "10/06/2026", "general_url": "https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/real-world-evidence" }, { "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": "08/06/2026", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/ebola" }, { "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": "03/06/2026", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/african-medicines-agency-african-union" }, { "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": "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": "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": "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": "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": "Executive Steering Group on Shortages of Medical Devices (MDSSG)", "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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-professionals/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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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/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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "Corporate", "first_published_date": "15/04/2025", "last_updated_date": "10/02/2026", "general_url": "https://www.ema.europa.eu/en/about-us/fees-payable-european-medicines-agency/annual-fees-payable-european-medicines-agency" }, { "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": "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": "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/womens-health/medicines-during-pregnancy-breastfeeding" }, { "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": "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": "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": "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": "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": "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" }, { "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": "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": "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": "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": "Human", "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": "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": "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": "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": "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": "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": "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": "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": "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": "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 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": "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": "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": "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": "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": "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": "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": "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/chmp-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": "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/pharmaceutical-industry/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": "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": "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": "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": "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": "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": "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": "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": "27/07/2025", "general_url": "https://www.ema.europa.eu/en/veterinary-regulatory-overview/post-authorisation-veterinary-medicines/pharmacovigilance-veterinary-medicines/eudravigilance-veterinary" }, { "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": "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": "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": "Cluster activities", "summary": "The European Medicines Agency (EMA) holds regular meetings 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": "Human;Veterinary;Corporate", "first_published_date": "29/09/2015", "last_updated_date": "17/07/2025", "general_url": "https://www.ema.europa.eu/en/partners-networks/international-activities/cluster-activities" }, { "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": "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": "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/healthcare-professionals/healthcare-professionals-key-documents" }, { "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": "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": "Requesting scientific advice, protocol assistance and qualification of novel methodologies 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-protocol-assistance-qualification-novel-methodologies-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": "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": "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": "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": "11/06/2025", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice/mutual-recognition-agreements-mra" }, { "title": "Healthcare professionals engagement", "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/healthcare-professionals/healthcare-professionals-engagement" }, { "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": "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": "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;Veterinary", "first_published_date": "21/09/2023", "last_updated_date": "29/04/2025", "general_url": "https://www.ema.europa.eu/en/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": "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/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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "(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": "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": "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": "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": "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": "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": "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": "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": "The procedure described here is intended to provide guidance and assist parallel distributors to fulfil their obligations, without prejudice to the interpretation of Community Directives and Regulatons by the European Commission and/or European Court of Justice.", "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": "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": "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": "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": "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": "Name Review Group form", "summary": "", "categories": "Human", "first_published_date": "01/06/2016", "last_updated_date": "05/09/2024", "general_url": "https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/marketing-authorisation-guidance-documents/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": "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": "The European Medicines Agency's (EMA) Environmental Risk Assessment European Specialised Expert Community (ERA ESEC) is a platform for information-sharing and interactions between experts in the environmental risk assessment field.", "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": "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": "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": "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 2016-2025.", "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": "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": "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": "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/healthcare-professionals/resources-healthcare-professionals" }, { "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 working 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": "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": "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": "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": "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": "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": "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": "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": "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": "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/pharmaceutical-industry/industry-stakeholder-platform-meetings" }, { "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": "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": "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": "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": "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": "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": "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": "The European Medicines Agency's (EMA) Non-Clinical and New Approach Methodologies European Specialised Expert Community is a platform for information-sharing and interactions between experts in the non-clinical field, including on new approach methodologies.", "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": "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. Working 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": "Archive of development of good pharmacovigilance practices", "summary": "", "categories": "Human", "first_published_date": "12/04/2013", "last_updated_date": "09/09/2023", "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": "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-other-groups/chmp-working-parties-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": "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": "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": "Procurement and grant activities 2025", "summary": "This page is an archive of the European Medicines Agency's tenders from 2025 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-2025" }, { "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": "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": "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": "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": "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": "Regulatory information in this area is identical for veterinary and human medicines.", "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "CAT: meeting archive 2017-2020", "summary": "This is an archive of the monthly reports, agendas and minutes from the Committee for Advanced Therapies (CAT) from 2017 to 2020.", "categories": "Human", "first_published_date": "15/06/2016", "last_updated_date": "23/06/2022", "general_url": "https://www.ema.europa.eu/en/committees/committee-advanced-therapies-cat/cat-meeting-archive-2017-2020" }, { "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": "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": "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": "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": "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": "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": "Patient and consumer engagement", "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/patient-consumer-engagement" }, { "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": "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": "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": "The EudraGMDP database is the EU database on manufacturing, import and wholesale-distribution authorisations as well as good manufacturing-practice (GMP) and good-distribution-practice (GDP) certificates. A public version of the database has been available since 2011. This allows public access to the information in the database that is not of a commercially or personally confidential nature.", "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": "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": "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": "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": "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": "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 had a working arrangement in place since 2021, allowing the exchange of 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": "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": "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": "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": "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/immunologicals-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": "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": "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": "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": "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": "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": "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": "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": "Canada", "summary": "The European Commission, the European Medicines Agency (EMA) and Health Canada have had working arrangements in place since 2007, allowing for the exchange of 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": "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": "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": "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/committee-medicinal-products-human-use-chmp/chmp-meeting-archive-2016-2018" }, { "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": "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": "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": "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 procedure and a national procedure.", "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": "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": "Training opportunities for non-EU regulators", "summary": "EMA supports non-European Union (EU) regulators by organising dedicated awareness sessions to provide them an insight into the EU medicine regulatory system and by making available information on relevant EU training opportunities that are open for their participation.", "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": "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": "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": "The European Medicines Agency (EMA) works with the European Directorate for the Quality of Medicines and HealthCare (EDQM), a directorate of the Council of Europe.", "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": "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": "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": "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": "Questions and answers: Urgent Union procedures (Article 107i)", "summary": "This page lists questions that stakeholders, particularly marketing-authorisation holders (MAHs), may have on urgent Union procedures.", "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": "This page lists questions which stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 31 referral resulting from the evaluation of data from pharmacovigilance activities.", "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": "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": "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/committee-veterinary-medicinal-products-cvmp/cvmp-meeting-archive-2016-2018" }, { "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "Japan", "summary": "The European Commission and European Medicines Agency (EMA) have had working 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": "Fellowship programmes involve exchanging staff for a short period of time. They enable the European Medicines Agency (EMA) and non-European Union (EU) regulators to exchange best practices, enhance mutual understanding and work together more closely.", "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": "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 a working arrangement 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": "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 working arrangements in place since 2015, allowing for the exchange of 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": "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": "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": "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": "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": "Human", "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "Questions and answers: Article 20 non-pharmacovigilance procedures", "summary": "This page lists questions that stakeholders, particularly marketing-authorisation holders (MAHs), may have on an Article 20 non-pharmacovigilance procedure.", "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": "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": "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-multidisciplinary-guidelines" }, { "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": "This is an archive of the monthly reports, agendas and minutes from the Committee for Advanced Therapies (CAT) from 2013 to 2016.", "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": "HMPC: meeting archive 2015-2020", "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/hmpc-meeting-archive-2015-2020" }, { "title": "COMP: meeting archive 2015-2020", "summary": "This is an archive of the monthly meeting reports, agendas and minutes from the Committee for Orphan Medicinal Products (COMP) from 2015 to 2020.", "categories": "Human", "first_published_date": "15/06/2016", "last_updated_date": "15/06/2016", "general_url": "https://www.ema.europa.eu/en/comp-meeting-archive-2015-2020" }, { "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": "Pre-submission request form", "summary": "Request for a European Medicines Agency procedure prior to the submission of a marketing authorisation application or Article 58 Application.", "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": "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": "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 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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "CAT: meeting archive 2009-2012", "summary": "This is an archive of the meeting reports from the Committee for Advanced Therapies (CAT) from 2009 to 2012.", "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": "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/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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "Scientific guidelines for herbal medicinal products", "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/scientific-guidelines-herbal-medicinal-products" }, { "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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": "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 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": "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": "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": "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": "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": "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-reporting/policies-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 for human medicines", "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-human-medicines" }, { "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": "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": "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": "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": "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": "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" } ] }