19/12/2024 | Shortage: Cyanokit | New |
19/12/2024 | Medicine: Nobivac L4 | Updated |
19/12/2024 | Medicine: Versican Plus DHPPi | Updated |
19/12/2024 | Medicine: Versican Plus DHPPi/L4 | Updated |
19/12/2024 | Page: Trametinib product-specific bioequivalence guideline | New |
19/12/2024 | Medicine: Idelvion | Updated |
19/12/2024 | Medicine: Axitinib Accord | Updated |
19/12/2024 | Medicine: Carbaglu | Updated |
19/12/2024 | Medicine: Purevax RCP FeLV | Updated |
19/12/2024 | Medicine: Purevax RCP | Updated |
19/12/2024 | Medicine: Purevax FeLV | Updated |
19/12/2024 | Document: Article 57 product data | Updated |
19/12/2024 | DHPC: Alofisel - direct healthcare professional communication (DHPC) | New |
18/12/2024 | Medicine: Veklury | Updated |
18/12/2024 | Page: Frequently asked questions about parallel distribution | Updated |
18/12/2024 | Medicine: Vanflyta | Updated |
18/12/2024 | Medicine: Simulect | Updated |
18/12/2024 | Medicine: Travatan | Updated |
18/12/2024 | Medicine: Zyprexa Velotab | Updated |
18/12/2024 | Medicine: Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) | Updated |
18/12/2024 | Medicine: Voncento | Updated |
18/12/2024 | Document: Standard operating procedure for processing of requests for fee reduction falling under paragraph 5 of Article 6 of Regulation (EU) 2024/568 | New |
18/12/2024 | Medicine: Respreeza | Updated |
18/12/2024 | Medicine: Piasky | Updated |
18/12/2024 | Medicine: Afstyla | Updated |
18/12/2024 | Page: Assessment templates and guidance (veterinary medicines) | Updated |
18/12/2024 | Document: Template - CVMP member comments on rapporteur’s reports | New |
18/12/2024 | Medicine: Takhzyro | Updated |
18/12/2024 | Medicine: Hympavzi | Updated |
18/12/2024 | Medicine: Vokanamet | Updated |
18/12/2024 | Page: Data quality framework for medicines regulation | Updated |
18/12/2024 | Medicine: Ontozry | Updated |
18/12/2024 | Page: Dexmedetomidine Accord | New |
18/12/2024 | Medicine: Lynparza | Updated |
18/12/2024 | Medicine: Invokana | Updated |
18/12/2024 | Medicine: Givlaari | Updated |
18/12/2024 | Medicine: Nintedanib Accord | Updated |
18/12/2024 | Medicine: Sapropterin Dipharma | Updated |
18/12/2024 | Event: Seventh European Medicines Agency (EMA) and EFPIA bilateral meeting | Updated |
18/12/2024 | Document: Highlights - Seventh European Medicines Agency (EMA) EFPIA bilateral meeting | New |
18/12/2024 | Page: Periodic safety update reports (PSURs) | Updated |
18/12/2024 | Event: Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting | Updated |
18/12/2024 | Document: Highlights - Third European Medicines Agency (EMA) and European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) bilateral meeting | New |
18/12/2024 | Medicine: Firdapse (previously Zenas) | Updated |
18/12/2024 | DHPC: Keppra - direct healthcare professional communication (DHPC) | New |
18/12/2024 | News: A common EU approach to data transparency in medicine regulation | New |
18/12/2024 | Document: Heads of Medicines Agencies / European Medicines Agency guidance document on the identification of commercially confidential information and personal data within the structure of the marketing-authorisation application: ... | Updated |
18/12/2024 | Medicine: Vevizye | Updated |
18/12/2024 | Event: Public event: advancing regulatory science research | Updated |
18/12/2024 | Document: Call for expression of interest for Academia to participate in the European Platform for Regulatory Science Research | New |
18/12/2024 | Medicine: Signifor | Updated |
18/12/2024 | Medicine: Wilzin | Updated |
18/12/2024 | Event: Fifth EMA/HMA Big Data Stakeholder Forum | Updated |
18/12/2024 | Document: Minutes of the CHMP meeting 22-25 July 2024 | New |
18/12/2024 | Page: ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Scientific guideline | Updated |
18/12/2024 | Document: ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions - Step 5 | New |
18/12/2024 | Document: Frequently asked questions about parallel distribution | Updated |
17/12/2024 | Medicine: Vizimpro | Updated |
17/12/2024 | Page: HMA / EMA Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (2016-2024) | Updated |
17/12/2024 | Document: Data access to medicinal products for human use - Chapter 5 Annex A: Product data elements accessible by stakeholder group | Updated |
17/12/2024 | Page: Medicine shortages and availability issues: guidance for regulators | Updated |
17/12/2024 | Document: Good practice guidance for communication to the public on medicines’ availability issues | Updated |
17/12/2024 | Document: Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1 | New |
17/12/2024 | Document: EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO) | Updated |
17/12/2024 | Document: Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies | Updated |
17/12/2024 | Document: Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application | Updated |
17/12/2024 | Document: EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 2 | New |
17/12/2024 | Event: Quarterly system demo - Q4 2024 | Updated |
17/12/2024 | Medicine: Uptravi | Updated |
17/12/2024 | Referral: Oxbryta - referral | Updated |
17/12/2024 | Medicine: Neuraceq | Updated |
17/12/2024 | Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Environmental Risk Assessment Working Party (ERAWP) 2025 | Updated |
17/12/2024 | Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 | Updated |
17/12/2024 | Shortage: Norditropin NordiFlex | Updated |
17/12/2024 | News: Emer Cooke, EMA’s Executive Director: 2024 achievements in medicine regulation | New |
17/12/2024 | Page: Biosimilar medicines: marketing authorisation | Updated |
17/12/2024 | Page: Pre-authorisation guidance | Updated |
17/12/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure | Updated |
17/12/2024 | Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changes | Updated |
17/12/2024 | Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications | Updated |
17/12/2024 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes | Updated |
17/12/2024 | Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs) | Updated |
17/12/2024 | Document: Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device | Updated |
17/12/2024 | Page: Type-IB variations: questions and answers | Updated |
17/12/2024 | Page: Type-II variations: questions and answers | Updated |
17/12/2024 | Page: Extensions of marketing authorisations: questions and answers | Updated |
17/12/2024 | Page: Grouping of variations: questions and answers | Updated |
17/12/2024 | Page: Worksharing: questions and answers | Updated |
17/12/2024 | Page: Transfer of marketing authorisation: questions and answers | Updated |
17/12/2024 | Page: Generic and hybrid applications | Updated |
17/12/2024 | Page: Renewal and annual re-assessment of marketing authorisation | Updated |
17/12/2024 | Page: Type-IA variations: questions and answers | Updated |
17/12/2024 | Document: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) | Updated |
17/12/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes | Updated |
17/12/2024 | Document: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications | Updated |
17/12/2024 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | Updated |
17/12/2024 | News: EMA business hours over holiday period | New |
17/12/2024 | Page: ICH S7B Non-clinical evaluation of the potential for delayed ventricular repolarization (QT interval prolongation) by human pharmaceuticals - Scientific guideline | Updated |
17/12/2024 | Document: Co-ordinating good manufacturing practice (GMP) inspections for centrally authorised products | Updated |
17/12/2024 | Document: CTIS newsflash - 17 December 2024 | New |
17/12/2024 | Medicine: Tyverb | Updated |
17/12/2024 | Medicine: Durysta | Updated |
16/12/2024 | Document: Big Data Steering Group (BDSG): 2024 report | New |
16/12/2024 | Herbal: Combination: Species pectorales - herbal medicinal product | Updated |
16/12/2024 | Medicine: Fluad | Updated |
16/12/2024 | Medicine: Hefiya | Updated |
16/12/2024 | Medicine: Hyrimoz | Updated |
16/12/2024 | Document: FAQs: How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 | Updated |
16/12/2024 | Medicine: Uzpruvo | Updated |
16/12/2024 | Medicine: Pemetrexed Pfizer (previously Pemetrexed Hospira) | Updated |
16/12/2024 | DHPC: Medroxyprogesterone acetate - direct healthcare professional communication (DHPC) | New |
16/12/2024 | Medicine: Naglazyme | Updated |
16/12/2024 | Medicine: Exjade | Updated |
16/12/2024 | News: Successful pilot paves the way for implementation of ePI | New |
16/12/2024 | Page: Electronic product information (ePI) | Updated |
16/12/2024 | Page: Applying for marketing authorisation: orphan medicines | Updated |
16/12/2024 | Document: Electronic product information (ePI) report: Experience gained from creation of ePI during regulatory procedures for EU human medicines | New |
16/12/2024 | Document: Union list of critical medicines | New |
16/12/2024 | Medicine: Vedrop | Updated |
16/12/2024 | Page: Applying for orphan designation | Updated |
16/12/2024 | Page: Requesting scientific advice or protocol assistance from EMA | Updated |
16/12/2024 | Document: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance with track-changes | Updated |
16/12/2024 | Medicine: Zavicefta | Updated |
16/12/2024 | Medicine: Lucentis | Updated |
16/12/2024 | Medicine: Evrenzo | Updated |
16/12/2024 | Page: Union list of critical medicines | Updated |
16/12/2024 | Document: Questions and answers on the Union list of critical medicines | Updated |
13/12/2024 | Page: Artificial intelligence | Updated |
13/12/2024 | Page: Live recombinant vector vaccines for veterinary use - Scientific guideline | Updated |
13/12/2024 | Page: Requesting certificates | Updated |
13/12/2024 | Medicine: Riltrava Aerosphere | Updated |
13/12/2024 | Medicine: Trixeo Aerosphere | Updated |
13/12/2024 | Page: Questions and answers for biological medicinal products | Updated |
13/12/2024 | Medicine: Flucelvax | Updated |
13/12/2024 | News: EMA Management Board: highlights of December 2024 meeting | New |
13/12/2024 | Document: 2025 Work plan for the European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG) | New |
13/12/2024 | Event: Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion | New |
13/12/2024 | Document: Mandate, objectives, and rules of procedure for the European Specialised Expert Community (ESEC) for Methodology | Updated |
13/12/2024 | Document: Highlight report - Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | New |
13/12/2024 | Page: Antimicrobials Working Party | Updated |
13/12/2024 | Medicine: Kizfizo | Updated |
13/12/2024 | Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Scientific Advice Working Party (SAWP-V) for 2025 | New |
13/12/2024 | Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 15 November 2024 | New |
13/12/2024 | Page: Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater - Scientific guideline | Updated |
13/12/2024 | Document: PRAC advice template | Updated |
13/12/2024 | Document: Pre-submission request form to the European Medicines Agency for veterinary medicinal product in accordance with Regulation (EU) 2019/6 | Updated |
13/12/2024 | Document: Guideline on assessing the environmental and human health risks of veterinary medicinal products in groundwater | Updated |
13/12/2024 | Document: Work plan for the Committee for Veterinary Medicinal Products (CVMP) Immunologicals Working Party (IWP) 2025 | Updated |
13/12/2024 | Document: Medicinal products for human use: Monthly figures - November 2024 | New |
13/12/2024 | Document: Work plan for the CVMP Novel Therapies & Technologies Working Party (NTWP) 2025 | Updated |
13/12/2024 | Page: Paediatric investigation plans: questions and answers | Updated |
13/12/2024 | Document: Scientific recommendations on classification of advanced therapy medicinal products | Updated |
13/12/2024 | Page: Maximum residue limits (MRL) | Updated |
13/12/2024 | Medicine: Topotecan Hospira | Updated |
13/12/2024 | Medicine: Bamlanivimab and etesevimab for COVID-19 | Updated |
13/12/2024 | Medicine: Evusheld | Updated |
13/12/2024 | Medicine: Ronapreve | Updated |
13/12/2024 | Medicine: Regkirona | Updated |
13/12/2024 | Page: Public-health advice on COVID-19 medicines | Updated |
13/12/2024 | Page: Emergency Task Force (ETF) documents | Updated |
13/12/2024 | Document: ETF statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants: December 2024 update | New |
13/12/2024 | Post-authorisation: Bridion - opinion on variation to marketing authorisation | New |
13/12/2024 | Document: Procedural advice on paediatric applications | Updated |
13/12/2024 | News: First treatment for peripheral thyrotoxicosis in patients with Allan-Herndon-Dudley syndrome | New |
13/12/2024 | Medicine: Stoboclo | New |
13/12/2024 | Medicine: Beyonttra | New |
13/12/2024 | Medicine: Andembry | New |
13/12/2024 | Medicine: Osenvelt | New |
13/12/2024 | Medicine: Paxneury | New |
13/12/2024 | Medicine: Zefylti | New |
13/12/2024 | Medicine: Welireg | New |
13/12/2024 | Medicine: Emcitate | New |
13/12/2024 | Medicine: Avtozma | New |
13/12/2024 | Medicine: Nemluvio | New |
13/12/2024 | Medicine: Kavigale | New |
13/12/2024 | Medicine: Kostaive | New |
13/12/2024 | Medicine: Seladelpar Gilead | New |
13/12/2024 | Medicine: Rytelo | New |
13/12/2024 | Medicine: Eydenzelt | New |
13/12/2024 | Medicine: Tuzulby | New |
13/12/2024 | Post-authorisation: Omvoh - opinion on variation to marketing authorisation | New |
13/12/2024 | Post-authorisation: Ofev - opinion on variation to marketing authorisation | New |
13/12/2024 | Orphan: EU/3/20/2305 - orphan designation for treatment of myelodysplastic syndromes | Updated |
13/12/2024 | Orphan: EU/3/17/1945 - orphan designation for treatment of Allan-Herndon-Dudley syndrome | Updated |
13/12/2024 | Orphan: EU/3/17/1930 - orphan designation for treatment of primary biliary cholangitis | Updated |
13/12/2024 | Orphan: EU/3/21/2532 - orphan designation for treatment of hereditary angioedema | Updated |
13/12/2024 | News: First medicine to treat rare genetic disorder causing cysts and tumours | New |
13/12/2024 | News: Alofisel withdrawn from the EU market | New |
13/12/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2024 | New |
13/12/2024 | Page: Big data | Updated |
13/12/2024 | Medicine: Latuda | Updated |
13/12/2024 | News: First treatment recommended for rare progressive lung conditions in children and adolescents | New |
13/12/2024 | Medicine: Beyfortus | Updated |
13/12/2024 | Medicine: Noxafil | Updated |
12/12/2024 | Medicine: Rydapt | Updated |
12/12/2024 | Medicine: Relistor | Updated |
12/12/2024 | Medicine: Sialanar | Updated |
12/12/2024 | Medicine: Pedea | Updated |
12/12/2024 | Medicine: Imjudo | Updated |
12/12/2024 | Medicine: Ledaga | Updated |
12/12/2024 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - November 2024 | Updated |
12/12/2024 | Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1: Registration requirements | Updated |
12/12/2024 | Medicine: Cystadrops | Updated |
12/12/2024 | Medicine: Cystadane | Updated |
12/12/2024 | Medicine: Isturisa | Updated |
12/12/2024 | Page: Investigation of bioequivalence - Scientific guideline | Updated |
12/12/2024 | Page: Signal management | Updated |
11/12/2024 | Document: CVMP work plan 2025 | New |
11/12/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
11/12/2024 | Document: QRD veterinary Appendix I - Adverse event (PhV) MSs reporting details | Updated |
11/12/2024 | Page: EudraVigilance Veterinary | Updated |
11/12/2024 | Document: Template for submission of comments for the Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet) | Updated |
11/12/2024 | Medicine: Lytgobi | Updated |
11/12/2024 | Medicine: Ibrance | Updated |
11/12/2024 | Medicine: Glivec | Updated |
11/12/2024 | Medicine: Cystagon | Updated |
11/12/2024 | Medicine: Ebvallo | Updated |
11/12/2024 | Medicine: Tezspire | Updated |
11/12/2024 | DHPC: Kexxtone - direct healthcare professional communication (DHPC) | Updated |
11/12/2024 | Medicine: Yuflyma | Updated |
11/12/2024 | Medicine: Qdenga | Updated |
11/12/2024 | Document: EMA communication perception survey report 2024 | New |
11/12/2024 | Medicine: Tacforius | Updated |
11/12/2024 | Medicine: Hexyon | Updated |
11/12/2024 | Medicine: Altuvoct | Updated |
11/12/2024 | Medicine: Rystiggo | Updated |
11/12/2024 | Medicine: Elahere | Updated |
11/12/2024 | Medicine: Teysuno | Updated |
11/12/2024 | Medicine: Corlentor | Updated |
11/12/2024 | Medicine: Dectova | Updated |
11/12/2024 | Medicine: Circadin | Updated |
10/12/2024 | Medicine: Juluca | Updated |
10/12/2024 | Medicine: Aubagio | Updated |
10/12/2024 | Medicine: Braftovi | Updated |
10/12/2024 | Medicine: Mektovi | Updated |
10/12/2024 | Medicine: Tivicay | Updated |
10/12/2024 | Medicine: Triumeq | Updated |
10/12/2024 | Medicine: Dovato | Updated |
10/12/2024 | Page: Veterinary product information (QRD) templates | Updated |
10/12/2024 | Event: 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA) | Updated |
10/12/2024 | Document: European Shortages Monitoring Platform (ESMP): Stakeholder engagement plan | Updated |
10/12/2024 | Document: Methodology European Specialised Expert Community (ESEC): Members | Updated |
10/12/2024 | Document: Three-year rolling work plan for the Quality Innovation Group (QIG) 2025-2027 | New |
10/12/2024 | Document: Clinical trial information system (CTIS) public portal trial results | Updated |
10/12/2024 | Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions | Updated |
10/12/2024 | Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP) | Updated |
10/12/2024 | Document: Guidance notes on the use of Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) terminology for reporting suspected adverse events in animals and humans - Rev.16 | Updated |
10/12/2024 | Document: Agenda - PDCO agenda of the 10-13 December 2024 meeting | New |
10/12/2024 | Event: Cancer Medicines Forum: October 2024 | New |
10/12/2024 | Document: QRD veterinary v.9.1 – Implementation plan | New |
10/12/2024 | Document: QRD veterinary combined label-leaflet annotated template (English) v.9.1 | New |
10/12/2024 | Document: QRD veterinary product-information annotated template (English) version 9.1 highlighted | New |
10/12/2024 | Document: QRD veterinary product-information annotated template (English) version 9.1 | New |
10/12/2024 | Medicine: Aquipta | Updated |
10/12/2024 | Medicine: Praluent | Updated |
10/12/2024 | Event: 2024 annual meeting of the members and Coordinating Group of the European network of paediatric research at the EMA (Enpr-EMA) | Updated |
10/12/2024 | Medicine: Opuviz | Updated |
10/12/2024 | Document: Report from the 2024 annual workshop of the European network of paediatric research at EMA (Enpr-EMA) | New |
09/12/2024 | Medicine: MenQuadfi | Updated |
09/12/2024 | Document: European Medicines Agency mid-year report 2024 (January-June 2024) | New |
09/12/2024 | Event: Thirteenth meeting of the industry stakeholder platform on research and development support | Updated |
09/12/2024 | Event: 19th industry stakeholder platform - operation of European Union (EU) pharmacovigilance | Updated |
09/12/2024 | Document: Annual report of the Good Clinical Practice Inspectors Working Group 2023 | New |
09/12/2024 | DHPC: Cyanokit - direct healthcare professional communication (DHPC) | New |
09/12/2024 | Document: Applications for new human medicines under evaluation: December 2024 | New |
09/12/2024 | Document: Letter of Support for intermediate Age-Related Macular Degeneration (AMD) biomarker and novel clinical endpoint development | New |
09/12/2024 | Document: Notification in preparation for the New fee regulation and new prepayment system for certificates of medicinal products, with implementation from January 2025 | New |
09/12/2024 | Page: Public information on medicine shortages | Updated |
09/12/2024 | Page: Medicine shortages and availability issues: guidance for companies | Updated |
09/12/2024 | Document: Guidance for industry on implementing shortage mitigation plans (SMP) | New |
09/12/2024 | Document: Guidance for industry on implementing shortage prevention plans (SPP) | New |
09/12/2024 | Page: Medicine shortage communications (MSC) | New |
09/12/2024 | Document: Medicine shortage communication (MSC) template | New |
09/12/2024 | Document: Agenda of the CHMP meeting 9-12 December 2024 | New |
09/12/2024 | Event: European Commission/EMA meeting with stakeholders on Translarna (ataluren) | Updated |
09/12/2024 | Page: Signal management (veterinary medicines) | Updated |
09/12/2024 | Medicine: Yesafili | Updated |
06/12/2024 | Event: Q&A clinic on post-authorisation procedure management in IRIS | New |
06/12/2024 | Page: Quality of medicines questions and answers: Part 1 | Updated |
06/12/2024 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 December 2024 | New |
06/12/2024 | Medicine: Icthiovac ERM | New |
06/12/2024 | Medicine: Poulvac Procerta HVT-IBD-ND | New |
06/12/2024 | Document: European Medicines Agency’s data protection notice regarding the experts database and the handling of competing interests of scientific committees’ members and experts | Updated |
06/12/2024 | Medicine: Lixiana | Updated |
06/12/2024 | Medicine: Votubia | Updated |
06/12/2024 | Document: Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials | New |
06/12/2024 | Event: Q&A Clinic on post-authorisation procedure management in IRIS - 11 Dec 2024 | New |
06/12/2024 | Medicine: Bemrist Breezhaler | Updated |
06/12/2024 | Medicine: Atectura Breezhaler | Updated |
06/12/2024 | Referral: Finasteride- and dutasteride-containing medicinal products - referral | Updated |
05/12/2024 | Medicine: Scemblix | Updated |
05/12/2024 | Medicine: Tafinlar | Updated |
05/12/2024 | DHPC: Ibandronic acid Accord - direct healthcare professional communication (DHPC) | New |
05/12/2024 | Medicine: Mekinist | Updated |
05/12/2024 | Medicine: Alli (previously Orlistat GSK) | Updated |
05/12/2024 | Medicine: Vantavo (previously Alendronate sodium and colecalciferol, MSD) | Updated |
05/12/2024 | Medicine: Adrovance | Updated |
05/12/2024 | Medicine: Esperoct | Updated |
05/12/2024 | Medicine: Pyzchiva | Updated |
05/12/2024 | Medicine: Spexotras | Updated |
05/12/2024 | Medicine: Baqsimi | Updated |
05/12/2024 | Page: Clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Scientific guideline | Updated |
05/12/2024 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice in hemoglobinopathies | Updated |
05/12/2024 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties meeting with all eligible organisations - 2024 | Updated |
05/12/2024 | Medicine: Arsenic trioxide Accord | Updated |
05/12/2024 | Document: Guidance for applicants seeking scientific support and advice on traditional herbal medicinal products | Updated |
05/12/2024 | Medicine: Ovaleap | Updated |
05/12/2024 | Medicine: Fosavance | Updated |
05/12/2024 | Medicine: Theralugand | Updated |
05/12/2024 | Event: Submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS) | Updated |
05/12/2024 | Document: Three-year work plan for the Quality Drafting Group (QDG) of the Committee on Herbal Medicinal Products (HMPC) | Updated |
05/12/2024 | Document: Data protection notice for the Experts Management Tool and the handling of competing interests | New |
05/12/2024 | Medicine: Jcovden (previously COVID-19 Vaccine Janssen) | Updated |
05/12/2024 | Document: Jcovden : Periodic safety update report assessment 25 February 2023 to 24 February 2024 | New |
04/12/2024 | Document: Guidance on the electronic submission of information on investigational medicinal products for human use in the Extended EudraVigilance medicinal product dictionary (XEVMPD) | Updated |
04/12/2024 | Medicine: Advate | Updated |
04/12/2024 | Medicine: Kovaltry | Updated |
04/12/2024 | Page: How to pay | Updated |
04/12/2024 | Document: How to pay fees and charges levied by EMA: Guidance to marketing authorisation holders and applicants | New |
04/12/2024 | PSUSA: PSUSA/00000772/202404 - periodic safety update report single assessment | New |
04/12/2024 | Document: Bimervax: Periodic safety update report assessment 30 March 2023 to 29 September 2023 | New |
04/12/2024 | Document: EVVet3 EVWeb Production - Release notes | Updated |
04/12/2024 | Document: Record of data processing activity relating to Security Access Control System | Updated |
04/12/2024 | Document: European Medicines Agency’s data protection notice for the operation of the Security Access Control System | Updated |
04/12/2024 | Document: Agenda - Medicine Shortages (SPOC) Working Party 5 December 2024 | New |
04/12/2024 | Page: Clinical requirements for non replacement therapy in haemophilia A and B - Scientific guideline | Updated |
04/12/2024 | Document: Medicine shortage mitigation plan - template | Updated |
04/12/2024 | Document: Medicine shortage prevention plan - template | Updated |
04/12/2024 | Medicine: Menveo | Updated |
04/12/2024 | Medicine: Scintimun | Updated |
04/12/2024 | Document: Scintimun-H-C-PSUSA-00000385-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation | New |
03/12/2024 | Medicine: Bevespi Aerosphere | Updated |
03/12/2024 | Document: List of substances and products subject to worksharing for signal management | Updated |
03/12/2024 | Medicine: Tauvid | Updated |
03/12/2024 | Medicine: Enhertu | Updated |
03/12/2024 | Document: Pediatric Cluster Terms of Reference | Updated |
03/12/2024 | Medicine: Celsentri | Updated |
03/12/2024 | Medicine: Xolair | Updated |
03/12/2024 | Medicine: Casgevy | Updated |
03/12/2024 | Medicine: Tasigna | Updated |
03/12/2024 | Event: Translating innovation into access for ATMPs: third EU-Innovation network multi-stakeholder meeting | Updated |
03/12/2024 | Orphan: EU/3/23/2828 - orphan designation for treatment of transthyretin-mediated amyloidosis | Updated |
03/12/2024 | Medicine: Briviact (in Italy: Nubriveo) | Updated |
03/12/2024 | Document: Briviact-H-C-PSUSA-00010447-202401 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation | New |
03/12/2024 | Event: EU NTC ten year anniversary event | Updated |
03/12/2024 | Document: Report - EU NTC ten year anniversary event | New |
03/12/2024 | Medicine: Kimmtrak | Updated |
03/12/2024 | Page: Clinical evaluation of medicinal products used in weight control - Scientific guideline | Updated |
03/12/2024 | Document: Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control | New |
03/12/2024 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 December 2024 | Updated |
03/12/2024 | Document: Agenda of the COMP meeting 3-5 December 2024 | New |
03/12/2024 | Document: EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 2: Format for the electronic submission of veterinary medicinal product information | Updated |
03/12/2024 | Medicine: Lumykras | Updated |
03/12/2024 | Document: Lumykras : EPAR - Risk management plan | New |
03/12/2024 | Document: Agenda of the CVMP meeting 3-5 December 2024 | New |
03/12/2024 | Document: Record of data processing activity for the Experts Management Tool and the handling of competing interests | Updated |
03/12/2024 | Document: Expected publication dates of PRAC recommendations on safety signals | Updated |
03/12/2024 | DHPC: Metamizole - direct healthcare professional communication (DHPC) | New |
03/12/2024 | Orphan: EU/3/16/1752 - orphan designation for treatment of haemophilia A | Updated |
02/12/2024 | Medicine: Eribulin Baxter | Updated |
02/12/2024 | Medicine: Tavlesse | Updated |
02/12/2024 | PSUSA: PSUSA/00002204/202404 - periodic safety update report single assessment | New |
02/12/2024 | Medicine: Nustendi | Updated |
02/12/2024 | Medicine: Nilemdo | Updated |
02/12/2024 | Medicine: Cablivi | Updated |
02/12/2024 | Medicine: Prevexxion RN+HVT+IBD | Updated |
02/12/2024 | Page: National competent authorities (human) | Updated |
02/12/2024 | Medicine: Metacam | Updated |
02/12/2024 | Medicine: Sancuso | Updated |
02/12/2024 | Medicine: Frontpro (previously Afoxolaner Merial) | Updated |
02/12/2024 | Medicine: Cerezyme | Updated |
02/12/2024 | Event: Committee for Advanced Therapies (CAT): 4-6 December 2024 | Updated |
02/12/2024 | Medicine: Fabhalta | Updated |
02/12/2024 | Document: Agenda of the CAT meeting 4-6 December 2024 | New |
02/12/2024 | Document: Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activities | Updated |
02/12/2024 | Event: Paediatric Committee (PDCO): 15-18 October 2024 | Updated |
02/12/2024 | Document: Minutes - PDCO minutes of the 15-18 October 2024 meeting | New |