| 28/05/2025 | Medicine: Absimky | Updated |
| 28/05/2025 | Medicine: NovoRapid | Updated |
| 28/05/2025 | Medicine: Riximyo | Updated |
| 28/05/2025 | Medicine: Efficib | Updated |
| 28/05/2025 | Medicine: Truxima | Updated |
| 28/05/2025 | Medicine: Xolair | Updated |
| 28/05/2025 | Event: EMA workshop on primary efficacy endpoints for antivirals and monoclonal antibodies intended for the treatment of COVID-19 and influenza | Updated |
| 28/05/2025 | Page: Nitrosamine impurities: guidance for marketing authorisation holders | Updated |
| 28/05/2025 | Medicine: Sixmo | Updated |
| 28/05/2025 | Page: Quality of medicines questions and answers: Part 2 | Updated |
| 28/05/2025 | Page: Scientific and technical recommendations: Veterinary Medicines Regulation | Updated |
| 28/05/2025 | Medicine: Cubicin | Updated |
| 28/05/2025 | Medicine: Lacosamide Accord | Updated |
| 28/05/2025 | Medicine: Pemetrexed medac | Updated |
| 28/05/2025 | Shortage: Champix | Updated |
| 28/05/2025 | PSUSA: PSUSA/00000210/202408 - periodic safety update report single assessment | New |
| 28/05/2025 | PSUSA: PSUSA/00001603/202408 - periodic safety update report single assessment | New |
| 28/05/2025 | Medicine: Jemperli | Updated |
| 28/05/2025 | Medicine: Enhertu | Updated |
| 28/05/2025 | Medicine: Emgality | Updated |
| 28/05/2025 | Medicine: Ocrevus | Updated |
| 28/05/2025 | Medicine: Adtralza | Updated |
| 28/05/2025 | Document: Annex to 27-30 January 2025 CHMP Minutes | New |
| 28/05/2025 | Document: Minutes of the CHMP meeting 27-30 January 2025 | New |
| 28/05/2025 | Medicine: Ibuprofen Gen.Orph | Updated |
| 28/05/2025 | Medicine: Lyfnua | Updated |
| 28/05/2025 | Medicine: Privigen | Updated |
| 28/05/2025 | DHPC: Ixchiq - direct healthcare professional communication (DHPC) | New |
| 28/05/2025 | Event: Strengthening evidence generation in the EU | New |
| 28/05/2025 | Post-authorisation: Amyvid - withdrawal of application for variation to marketing authorisation | Updated |
| 28/05/2025 | Page: List of medicines under additional monitoring | Updated |
| 28/05/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 28/05/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 28/05/2025 | Document: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union | Updated |
| 28/05/2025 | Document: Annex V - List of hydroxyethyl starch (HES)-containing medicinal products in the European Union | Updated |
| 28/05/2025 | Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) | Updated |
| 28/05/2025 | Event: Fourteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
| 28/05/2025 | News: EMA closed 29-30 May | New |
| 27/05/2025 | Medicine: Xenpozyme | Updated |
| 27/05/2025 | Medicine: Galafold | Updated |
| 27/05/2025 | Medicine: Icandra (previously Vildagliptin / metformin hydrochloride Novartis) | Updated |
| 27/05/2025 | Medicine: Eucreas | Updated |
| 27/05/2025 | Medicine: Paxlovid | Updated |
| 27/05/2025 | Medicine: Zomarist | Updated |
| 27/05/2025 | Medicine: Prevymis | Updated |
| 27/05/2025 | Medicine: Ovaleap | Updated |
| 27/05/2025 | Medicine: Sorafenib Accord | Updated |
| 27/05/2025 | Medicine: HyQvia | Updated |
| 27/05/2025 | Medicine: Inflectra | Updated |
| 27/05/2025 | Document: Start of procedure - extension of marketing authorisation (26 April - 22 May 2025) | New |
| 27/05/2025 | Medicine: Ixchiq | Updated |
| 27/05/2025 | Document: Start of procedure: Type II variation - extension of indication (26 April - 22 May 2025) | New |
| 27/05/2025 | Document: Minutes of the CHMP meeting 9-12 December 2024 | New |
| 27/05/2025 | Document: Overview of (invented) names reviewed in April 2025 by the Name Review Group (NRG) adopted at the CHMP meeting of 22 May 2025 | New |
| 27/05/2025 | Document: CTIS newsflash - 27 May 2025 | New |
| 27/05/2025 | Document: List of centrally authorised products with safety-related changes to the product information | Updated |
| 27/05/2025 | Document: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2025 | New |
| 27/05/2025 | Page: EudraVigilance training and support | Updated |
| 27/05/2025 | PIP: EMEA-003306-PIP01-22 - paediatric investigation plan | Updated |
| 27/05/2025 | PSUSA: PSUSA/00010355/202409 - periodic safety update report single assessment | New |
| 27/05/2025 | Medicine: Calquence | Updated |
| 27/05/2025 | Page: Quality of medicines questions and answers: Part 1 | Updated |
| 27/05/2025 | Medicine: Voxzogo | Updated |
| 27/05/2025 | Page: Website outages and upgrades | Updated |
| 27/05/2025 | Medicine: Ranivisio | Updated |
| 27/05/2025 | Medicine: Epruvy (previously Ranibizumab Midas) | Updated |
| 26/05/2025 | Page: Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 26/05/2025 | Event: ADRA project - information session for veterinary pharmaceutical industry | Updated |
| 26/05/2025 | Medicine: Eksunbi | Updated |
| 26/05/2025 | Medicine: Otulfi | Updated |
| 26/05/2025 | Document: Floseal haemostatic matrix (Floseal VH S/D) - Procedural steps and scientific information after initial consultation (archive) | Updated |
| 26/05/2025 | Referral: Oxbryta - referral | Updated |
| 26/05/2025 | Referral: Mysimba - referral | Updated |
| 26/05/2025 | Medicine: Pyzchiva | Updated |
| 26/05/2025 | Medicine: Pylclari | Updated |
| 26/05/2025 | Medicine: Bimervax | Updated |
| 26/05/2025 | Medicine: Rixathon | Updated |
| 26/05/2025 | Event: Product Management Service (PMS) information day 2025 | Updated |
| 26/05/2025 | Page: COVID-19 medicines | Updated |
| 26/05/2025 | PIP: EMEA-003063-PIP03-22 - paediatric investigation plan | Updated |
| 26/05/2025 | Medicine: Cinainu | Updated |
| 23/05/2025 | Medicine: Lacosamide UCB | Updated |
| 23/05/2025 | Medicine: Ovitrelle | Updated |
| 23/05/2025 | Medicine: Vegzelma | Updated |
| 23/05/2025 | Medicine: Retsevmo | Updated |
| 23/05/2025 | Medicine: Advate | Updated |
| 23/05/2025 | Medicine: Pedmarqsi | Updated |
| 23/05/2025 | Medicine: Remsima | Updated |
| 23/05/2025 | Medicine: Ifirmacombi | Updated |
| 23/05/2025 | Medicine: Ifirmasta (previously Irbesartan Krka) | Updated |
| 23/05/2025 | Medicine: Menveo | Updated |
| 23/05/2025 | Medicine: Ristfor | Updated |
| 23/05/2025 | Medicine: Velmetia | Updated |
| 23/05/2025 | Medicine: Janumet | Updated |
| 23/05/2025 | Medicine: Ebymect | Updated |
| 23/05/2025 | Document: Timetable: Type II variation and worksharing application alternative monthly assessment | Updated |
| 23/05/2025 | Document: Timetable: Type II variation and worksharing application weekly assessment | Updated |
| 23/05/2025 | Medicine: Kisplyx | Updated |
| 23/05/2025 | Medicine: Komboglyze | Updated |
| 23/05/2025 | Medicine: Zoledronic Acid Accord | Updated |
| 23/05/2025 | Medicine: Xigduo | Updated |
| 23/05/2025 | Medicine: Epidyolex | Updated |
| 23/05/2025 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 May 2025 | New |
| 23/05/2025 | Medicine: Kostaive | Updated |
| 23/05/2025 | Medicine: Inhixa | Updated |
| 23/05/2025 | Medicine: Blitzima | Updated |
| 23/05/2025 | Document: European Medicines Agency's data protection notice for selection and recruitment | Updated |
| 23/05/2025 | Document: European Union example instances - E2B(R3) testing files | Updated |
| 23/05/2025 | Document: Test cases (1a-10) RTFs | Updated |
| 23/05/2025 | Document: EudraVigilance registration manual | Updated |
| 23/05/2025 | Document: EudraVigilance - EVWEB user manual | Updated |
| 23/05/2025 | Medicine: Arexvy | Updated |
| 23/05/2025 | Document: Timetable: Type IB variation requiring linguistic review | Updated |
| 23/05/2025 | Event: Management Board meeting: 13 March 2025 | Updated |
| 23/05/2025 | Document: Timetable: Type II variation and worksharing application monthly assessment | Updated |
| 23/05/2025 | Document: Timetable: Type II variation and worksharing application assessment - ATMP | Updated |
| 23/05/2025 | Event: HMA/EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment | Updated |
| 23/05/2025 | Document: Minutes of the Cancer Medicines Forum - March 2025 | New |
| 23/05/2025 | Page: ICH M12 on drug interaction studies - Scientific guideline | Updated |
| 23/05/2025 | Page: ICH E6 Good clinical practice - Scientific guideline | Updated |
| 23/05/2025 | Document: Overview of comments received on ICH E6(R3) guideline for good clinical practice – Annex 2 - Step 2b | New |
| 23/05/2025 | Event: Workshop on the use of Bayesian statistics in clinical development | Updated |
| 23/05/2025 | Page: ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline | Updated |
| 23/05/2025 | Document: Overview of comments received on ICH M11 technical specification during second consultation (EMA/CHMP/ICH/778800/2022) | New |
| 23/05/2025 | Page: Consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets - Scientific guideline | New |
| 23/05/2025 | Document: Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets | New |
| 23/05/2025 | News: Changes to the use of antibiotic azithromycin | New |
| 23/05/2025 | News: EMA starts review of ipidacrine-containing medicines | New |
| 23/05/2025 | Referral: Ipidacrine-containing medicinal products - referral | New |
| 23/05/2025 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
| 23/05/2025 | Medicine: Blenrep | New |
| 23/05/2025 | Post-authorisation: Lutathera - withdrawal of application for variation to marketing authorisation | New |
| 23/05/2025 | Post-authorisation: Tevimbra - opinion on variation to marketing authorisation | New |
| 23/05/2025 | Post-authorisation: Rezolsta - opinion on variation to marketing authorisation | New |
| 23/05/2025 | Medicine: Atropine sulfate FGK | New |
| 23/05/2025 | Medicine: Itovebi | New |
| 23/05/2025 | Medicine: Aucatzyl | New |
| 23/05/2025 | Medicine: Emtricitabine / Tenofovir alafenamide Viatris | New |
| 23/05/2025 | Medicine: Riulvy | New |
| 23/05/2025 | Medicine: Rolcya | New |
| 23/05/2025 | Medicine: Maapliv | New |
| 23/05/2025 | Post-authorisation: Imfinzi - opinion on variation to marketing authorisation | New |
| 23/05/2025 | Medicine: Bomyntra | New |
| 23/05/2025 | Medicine: Conexxence | New |
| 23/05/2025 | Post-authorisation: Saxenda - opinion on variation to marketing authorisation | New |
| 23/05/2025 | Medicine: Ezmekly | New |
| 23/05/2025 | Medicine: Teriparatide Ascend | New |
| 23/05/2025 | News: New treatment for adults with acute lymphoblastic leukaemia | New |
| 23/05/2025 | Document: Start of Union reviews adopted during the CHMP meeting of 19-22 May 2025 | New |
| 23/05/2025 | Medicine: Revestive | Updated |
| 23/05/2025 | Medicine: Nerlynx | Updated |
| 23/05/2025 | Medicine: Abrysvo | Updated |
| 23/05/2025 | Medicine: Xydalba | Updated |
| 22/05/2025 | Event: Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities July 2025 | New |
| 22/05/2025 | Medicine: Supemtek Tetra (previously Supemtek) | Updated |
| 22/05/2025 | Page: National competent authorities (human) | Updated |
| 22/05/2025 | Medicine: Uptravi | Updated |
| 22/05/2025 | Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 05-07 May 2025 | New |
| 22/05/2025 | Document: Orientation guide for patient representatives and healthcare professionals - EMA building | Updated |
| 22/05/2025 | Document: Orientation guide for delegates - EMA building | Updated |
| 22/05/2025 | Document: Agenda - EMA’s 30th anniversary scientific conference | Updated |
| 22/05/2025 | Document: Orientation guide for industry - EMA building | Updated |
| 21/05/2025 | Page: COVID-19 vaccines: key facts | Updated |
| 21/05/2025 | Event: European Society of Cardiology (ESC) bilateral meeting | New |
| 21/05/2025 | 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 |
| 21/05/2025 | Document: Scientific recommendations on classification of advanced therapy medicinal products | Updated |
| 21/05/2025 | Medicine: Scemblix | Updated |
| 21/05/2025 | Medicine: Pedea | Updated |
| 21/05/2025 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
| 21/05/2025 | Medicine: Teysuno | Updated |
| 21/05/2025 | Medicine: Instanyl | Updated |
| 21/05/2025 | Medicine: LysaKare | Updated |
| 21/05/2025 | Medicine: Poteligeo | Updated |
| 20/05/2025 | Medicine: Korjuny | Updated |
| 20/05/2025 | PIP: EMEA-001220-PIP07-20-M01 - paediatric investigation plan | Updated |
| 20/05/2025 | PIP: EMEA-001501-PIP09-21 - paediatric investigation plan | Updated |
| 20/05/2025 | PIP: EMEA-001214-PIP07-21 - paediatric investigation plan | Updated |
| 20/05/2025 | PIP: EMEA-003185-PIP01-22 - paediatric investigation plan | Updated |
| 20/05/2025 | Medicine: Tevimbra | Updated |
| 20/05/2025 | Medicine: Artesunate Amivas | Updated |
| 20/05/2025 | Medicine: Eltrombopag Accord | Updated |
| 20/05/2025 | Medicine: Beqvez (previously Durveqtix) | Updated |
| 20/05/2025 | Medicine: Zavicefta | Updated |
| 20/05/2025 | Medicine: Conbriza | Updated |
| 20/05/2025 | Medicine: Duavive | Updated |
| 20/05/2025 | Document: Agenda - PDCO agenda of the 20-23 May 2025 meeting | New |
| 20/05/2025 | Page: Electronic product information (ePI) | Updated |
| 19/05/2025 | PSUSA: PSUSA/00002492/202409 - periodic safety update report single assessment | New |
| 19/05/2025 | Medicine: Pelgraz | Updated |
| 19/05/2025 | Medicine: Brinavess | Updated |
| 19/05/2025 | Medicine: Sitagliptin / Metformin hydrochloride Accord | Updated |
| 19/05/2025 | Medicine: Vipdomet | Updated |
| 19/05/2025 | Medicine: Orencia | Updated |
| 19/05/2025 | Medicine: Noxafil | Updated |
| 19/05/2025 | Medicine: Adempas | Updated |
| 19/05/2025 | Medicine: Briviact (in Italy: Nubriveo) | Updated |
| 19/05/2025 | Medicine: Beovu | Updated |
| 19/05/2025 | Document: Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorisation holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products | Updated |
| 19/05/2025 | Medicine: Fymskina | Updated |
| 19/05/2025 | Document: Standard operating procedure for validation, publication, and maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues | New |
| 19/05/2025 | Event: Clinical Trials Information System (CTIS): Information day | Updated |
| 19/05/2025 | Medicine: Flixabi | Updated |
| 19/05/2025 | Document: European Medicines Agency’s Data Protection Notice for the Organisation Management System (OMS) activities | New |
| 19/05/2025 | Document: Records of data processing activity for the Organisation Management System (OMS) activities | New |
| 19/05/2025 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - May 2025 | Updated |
| 19/05/2025 | Event: Committee for Medicinal Products for Human Use (CHMP): 19-22 May 2025 | Updated |
| 19/05/2025 | Document: CTIS newsflash - 16 May 2025 | New |
| 19/05/2025 | Document: Medicinal products for human use: monthly figures - April 2025 | New |
| 19/05/2025 | Document: Network Data Steering Group workplan 2025-2028 | Updated |
| 19/05/2025 | Medicine: Bylvay | Updated |
| 19/05/2025 | Document: Public engagement highlights 2024 | New |
| 16/05/2025 | Document: Organisation chart: Advisory functions | Updated |
| 16/05/2025 | Medicine: Buprenorphine Neuraxpharm | Updated |
| 16/05/2025 | Medicine: Ogluo | Updated |
| 16/05/2025 | Medicine: Lyvdelzi (previously Seladelpar Gilead) | Updated |
| 16/05/2025 | Medicine: Sibnayal | Updated |
| 16/05/2025 | Post-authorisation: Bluevac BTV (previously Bluevac BTV8) - opinion on variation to marketing authorisation | New |
| 16/05/2025 | Medicine: Fluralaner Intervet | New |
| 16/05/2025 | Post-authorisation: NexGard Combo - opinion on variation to marketing authorisation | New |
| 16/05/2025 | Post-authorisation: Stronghold Plus - opinion on variation to marketing authorisation | New |
| 16/05/2025 | Medicine: Nobilis Multriva IBm+ND+Gm+REOm+EDS | New |
| 16/05/2025 | Medicine: Innovax-ND-IBD-ILT | New |
| 16/05/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 2025 | New |
| 16/05/2025 | Medicine: Cerdelga | Updated |
| 16/05/2025 | Medicine: Uzpruvo | Updated |
| 16/05/2025 | Medicine: Accofil | Updated |
| 16/05/2025 | Medicine: Eydenzelt | Updated |
| 16/05/2025 | Medicine: Bortezomib Hospira | Updated |
| 16/05/2025 | Medicine: Matever | Updated |
| 16/05/2025 | Medicine: Fingolimod Accord | Updated |
| 16/05/2025 | Document: EVVET – Data warehouse user manual | Updated |
| 16/05/2025 | Medicine: Remicade | Updated |
| 16/05/2025 | Medicine: Flucelvax | Updated |
| 16/05/2025 | Medicine: Enspryng | Updated |
| 16/05/2025 | EU-M4all: Mosquirix - opinion on medicine for use outside EU | Updated |
| 16/05/2025 | News: ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant | New |
| 16/05/2025 | Document: EMA recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2025-2026 | New |
| 16/05/2025 | Medicine: Imfinzi | Updated |
| 16/05/2025 | Medicine: Deqsiga | Updated |
| 16/05/2025 | Page: Advisory functions | Updated |
| 16/05/2025 | Document: Confidentiality undertaking for observers | Updated |
| 15/05/2025 | Medicine: Rinvoq | Updated |
| 15/05/2025 | Medicine: INOmax | Updated |
| 15/05/2025 | Medicine: Lorviqua | Updated |
| 15/05/2025 | Medicine: Osenvelt | Updated |
| 15/05/2025 | Medicine: Filsuvez | Updated |
| 15/05/2025 | Document: Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’ - Version 1.5 | New |
| 15/05/2025 | Document: External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use - Version 1.5 | New |
| 15/05/2025 | Medicine: Riluzole Zentiva | Updated |
| 15/05/2025 | Medicine: Sprycel | Updated |
| 15/05/2025 | Medicine: Opuviz | Updated |
| 15/05/2025 | Document: Annex - National provisions for SMEs applicable to the pharmaceutical sector | Updated |
| 15/05/2025 | Medicine: Rytelo | Updated |
| 15/05/2025 | Medicine: Dimethyl fumarate Mylan | Updated |
| 15/05/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025 | Updated |
| 15/05/2025 | Medicine: Sondelbay | Updated |
| 15/05/2025 | Medicine: Faslodex | Updated |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - August 2025 | New |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - July 2025 | New |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - September 2025 | New |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - October 2025 | New |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - November 2025 | New |
| 15/05/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - December 2025 | New |
| 15/05/2025 | Medicine: Uplizna | Updated |
| 15/05/2025 | Medicine: Winlevi | Updated |
| 15/05/2025 | Medicine: Kymriah | Updated |
| 15/05/2025 | PIP: EMEA-003049-PIP01-21-M01 - paediatric investigation plan | Updated |
| 15/05/2025 | PIP: EMEA-000639-PIP03-16-M03 - paediatric investigation plan | Updated |
| 15/05/2025 | Document: HMPC: overview of assessment work - priority list | Updated |
| 14/05/2025 | PIP: EMEA-000597-PIP03-15-M06 - paediatric investigation plan | Updated |
| 14/05/2025 | PIP: EMEA-003170-PIP01-21-M02 - paediatric investigation plan | Updated |
| 14/05/2025 | Document: Article 57 product data | Updated |
| 14/05/2025 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
| 14/05/2025 | Medicine: Isentress | Updated |
| 14/05/2025 | Medicine: Zabdeno | Updated |
| 14/05/2025 | Medicine: Mvabea | Updated |
| 14/05/2025 | Medicine: Clopidogrel Krka | Updated |
| 14/05/2025 | Medicine: Entresto | Updated |
| 14/05/2025 | Medicine: Neparvis | Updated |
| 14/05/2025 | Document: PMF dossier requirements - Questions and answers for PMF holders | Updated |
| 14/05/2025 | Event: European shortages monitoring platform (ESMP): updates and question and answer (Q&A) clinic for marketing authorisation holders (MAHs) | New |
| 14/05/2025 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
| 14/05/2025 | Medicine: Zyllt | Updated |
| 14/05/2025 | Document: Agenda of the CAT meeting 14-16 May 2025 | New |
| 14/05/2025 | Document: Agenda of the COMP meeting 13-15 May 2025 | New |
| 14/05/2025 | Document: Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 April 2025 | New |
| 14/05/2025 | Medicine: Tobi Podhaler | Updated |
| 13/05/2025 | PIP: EMEA-003568-PIP01-23 - paediatric investigation plan | New |
| 13/05/2025 | PIP: EMEA-003603-PIP01-24 - paediatric investigation plan | New |
| 13/05/2025 | PSUSA: PSUSA/00001606/202409 - periodic safety update report single assessment | New |
| 13/05/2025 | PSUSA: PSUSA/00010348/202409 - periodic safety update report single assessment | New |
| 13/05/2025 | PSUSA: PSUSA/00010929/202410 - periodic safety update report single assessment | New |
| 13/05/2025 | Medicine: Clopidogrel Krka d.d. (previously Zopya) | Updated |
| 13/05/2025 | Medicine: Clopidogrel TAD | Updated |
| 13/05/2025 | PIP: EMEA-002876-PIP02-23 - paediatric investigation plan | New |
| 13/05/2025 | Medicine: Kanjinti | Updated |
| 13/05/2025 | Medicine: Blincyto | Updated |
| 13/05/2025 | PIP: EMEA-002689-PIP02-23 - paediatric investigation plan | New |
| 13/05/2025 | PIP: EMEA-003176-PIP02-22 - paediatric investigation plan | New |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP) essentials: Industry and network reporting requirements | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP) Informational brief | Updated |
| 13/05/2025 | Document: Amended Biologics Working Party Vaccines Quality Operational Expert Group (BV-OEG) Influenza Meeting: EU recommendations for the seasonal influenza vaccine composition for the season 2025/2026 | Updated |
| 13/05/2025 | Medicine: Actelsar HCT | Updated |
| 13/05/2025 | Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP) | Updated |
| 13/05/2025 | Medicine: Enbrel | Updated |
| 13/05/2025 | Medicine: Dyrupeg | Updated |
| 13/05/2025 | Page: Medicines for human use under evaluation | Updated |
| 13/05/2025 | Medicine: Datroway | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities | Updated |
| 13/05/2025 | Document: Justification table templates | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP): Marketing authorisation holder reporting templates | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders | Updated |
| 13/05/2025 | Document: European Shortages Monitoring Platform (ESMP): National competent authority reporting templates | Updated |
| 12/05/2025 | Medicine: Xyrem | Updated |
| 12/05/2025 | Document: Minutes of the HMPC meeting 17-19 March 2025 | New |
| 12/05/2025 | Event: EMA/FVE info session for veterinary practitioners : Understanding the first report of sales and use of antimicrobials in animals | New |
| 12/05/2025 | PSUSA: PSUSA/00010571/202407 - periodic safety update report single assessment | New |
| 12/05/2025 | PSUSA: PSUSA/00003143/202409 - periodic safety update report single assessment | New |
| 12/05/2025 | PSUSA: PSUSA/00002643/202408 - periodic safety update report single assessment | New |
| 12/05/2025 | Medicine: Amlodipine / Valsartan Mylan | Updated |
| 12/05/2025 | PSUSA: PSUSA/00010072/202409 - periodic safety update report single assessment | New |
| 12/05/2025 | PSUSA: PSUSA/00010670/202409 - periodic safety update report single assessment | New |
| 12/05/2025 | Medicine: Voriconazole Accord | Updated |
| 12/05/2025 | Medicine: Olanzapine Teva | Updated |
| 12/05/2025 | Medicine: Pomalidomide Zentiva | Updated |
| 12/05/2025 | Medicine: Levetiracetam Hospira | Updated |
| 12/05/2025 | Medicine: Lucentis | Updated |
| 12/05/2025 | Medicine: Targretin | Updated |
| 12/05/2025 | Medicine: Yesafili | Updated |
| 12/05/2025 | Medicine: Omjjara | Updated |
| 12/05/2025 | Medicine: Aqumeldi | Updated |
| 12/05/2025 | Document: IVF Media G5 - Procedural steps and scientific information after initial consultation | Updated |
| 12/05/2025 | Shortage: NovoSeven (eptacog alfa) | New |
| 12/05/2025 | Document: Medicine shortage communication (MSC): Fiasp PumpCart and NovoRapid PumpCart | New |
| 12/05/2025 | Shortage: NovoRapid PumpCart (insulin aspart) | New |
| 12/05/2025 | Shortage: Fiasp PumpCart (insulin aspart) | New |
| 12/05/2025 | PIP: EMEA-001741-PIP04-17-M05 - paediatric investigation plan | Updated |
| 12/05/2025 | PIP: EMEA-003130-PIP02-23 - paediatric investigation plan | New |
| 12/05/2025 | Medicine: Rystiggo | Updated |
| 12/05/2025 | Referral: Ixchiq - referral | Updated |
| 08/05/2025 | Medicine: Carvykti | Updated |
| 08/05/2025 | Page: Careers | Updated |
| 08/05/2025 | Page: Who we are | Updated |
| 08/05/2025 | Document: EMA Gender equality plan 2025 - 2030 | New |
| 08/05/2025 | Medicine: Tuzulby | Updated |
| 08/05/2025 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
| 08/05/2025 | Document: Draft qualification opinion for Simcyp Simulator | New |
| 08/05/2025 | Medicine: Neupro | Updated |
| 08/05/2025 | Page: Supporting innovation | Updated |
| 08/05/2025 | Document: Process for the electronic submission of medicinal product information - Chapter 3 | Updated |
| 08/05/2025 | Document: European Medicines Agency Write PMS API implementation Guide (zip) | Updated |
| 08/05/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025 | New |
| 08/05/2025 | Referral: Finasteride- and dutasteride-containing medicinal products - referral | Updated |
| 08/05/2025 | News: Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines | New |
| 08/05/2025 | Page: Questions and answers for biological medicinal products | Updated |
| 08/05/2025 | Medicine: Givlaari | Updated |
| 08/05/2025 | Medicine: Vimpat | Updated |
| 08/05/2025 | Page: Good Manufacturing Practice (GMP) / Distribution Practice Practice (GDP) Inspectors Working Group | Updated |
| 08/05/2025 | Document: Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products | New |
| 08/05/2025 | Medicine: Tacforius | Updated |
| 08/05/2025 | Medicine: Synjardy | Updated |
| 08/05/2025 | Medicine: Tecentriq | Updated |
| 08/05/2025 | Medicine: Tremfya | Updated |
| 08/05/2025 | Medicine: Jentadueto | Updated |
| 08/05/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 March 2025 | Updated |
| 08/05/2025 | Medicine: Kayfanda | Updated |
| 08/05/2025 | Medicine: Brukinsa | Updated |
| 07/05/2025 | PSUSA: PSUSA/00010239/202408 - periodic safety update report single assessment | New |
| 07/05/2025 | Medicine: Cibinqo | Updated |
| 07/05/2025 | Medicine: Firazyr | Updated |
| 07/05/2025 | Medicine: Finlee | Updated |
| 07/05/2025 | Medicine: Ongentys | Updated |
| 07/05/2025 | Medicine: Zepatier | Updated |
| 07/05/2025 | Medicine: Cabazitaxel Accord | Updated |
| 07/05/2025 | Medicine: Breyanzi | Updated |
| 07/05/2025 | News: Leveraging the power of data for public and animal health | New |
| 07/05/2025 | Page: Artificial intelligence | Updated |
| 07/05/2025 | Page: Network Data Steering Group (NDSG) | Updated |
| 07/05/2025 | News: EMA starts review of Ixchiq (live attenuated chikungunya vaccine) | New |
| 07/05/2025 | Medicine: Evenity | Updated |
| 07/05/2025 | Medicine: Vectibix | Updated |
| 07/05/2025 | Medicine: Daurismo | Updated |
| 07/05/2025 | News: EMA closed on 9 May | New |
| 07/05/2025 | Medicine: Zejula | Updated |
| 07/05/2025 | Medicine: Bavencio | Updated |
| 07/05/2025 | Medicine: Urorec | Updated |
| 06/05/2025 | PSUSA: PSUSA/00010269/202407 - periodic safety update report single assessment | New |
| 06/05/2025 | PSUSA: PSUSA/00000761/202408 - periodic safety update report single assessment | New |
| 06/05/2025 | PSUSA: PSUSA/00010464/202407 - periodic safety update report single assessment | New |
| 06/05/2025 | Medicine: Vyjuvek | Updated |
| 06/05/2025 | Medicine: Herceptin | Updated |
| 06/05/2025 | Medicine: Lunsumio | Updated |
| 06/05/2025 | Medicine: Roctavian | Updated |
| 06/05/2025 | Page: PRIME: priority medicines | Updated |
| 06/05/2025 | Document: List of medicines currently in PRIME scheme | Updated |
| 06/05/2025 | Medicine: Bortezomib Sun | Updated |
| 06/05/2025 | Medicine: Briumvi | Updated |
| 06/05/2025 | Medicine: RoActemra | Updated |
| 06/05/2025 | Medicine: Zolgensma | Updated |
| 06/05/2025 | Document: Standard operating procedure for assignment of micro-, small- or medium-sized-enterprise status | Updated |
| 06/05/2025 | Document: Standard operating procedure for renewal of micro-, small- or medium-sized-enterprise status | Updated |
| 06/05/2025 | Medicine: Mavenclad | Updated |
| 06/05/2025 | Medicine: Sitagliptin / Metformin hydrochloride Sun | Updated |
| 06/05/2025 | Medicine: Elebrato Ellipta | Updated |
| 06/05/2025 | Medicine: Obodence | Updated |
| 06/05/2025 | Medicine: Sunitinib Accord | Updated |
| 06/05/2025 | Medicine: Posaconazole Accord | Updated |
| 06/05/2025 | Document: UPD registration guide for UI and API users | Updated |
| 06/05/2025 | Medicine: Iqirvo | Updated |
| 06/05/2025 | Medicine: Imatinib Accord | Updated |
| 06/05/2025 | Medicine: Abiraterone Accord | Updated |
| 06/05/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025 | Updated |
| 06/05/2025 | Document: Minutes - Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) (April 2025) | New |
| 06/05/2025 | Medicine: Mayzent | Updated |
| 06/05/2025 | Medicine: Arsenic trioxide Mylan | Updated |
| 06/05/2025 | Document: Agenda of the PRAC meeting 5-8 May 2025 | New |
| 06/05/2025 | Document: Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 2 - track changes | Updated |
| 06/05/2025 | 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 |
| 05/05/2025 | Medicine: Trelegy Ellipta | Updated |
| 05/05/2025 | Medicine: Ketoconazole Esteve (previously Ketoconazole HRA) | Updated |
| 05/05/2025 | Medicine: Leqembi | Updated |
| 05/05/2025 | Medicine: Circadin | Updated |
| 05/05/2025 | Medicine: Kavigale | Updated |
| 05/05/2025 | Document: List of signals discussed at PRAC since September 2012 | Updated |
| 05/05/2025 | Medicine: Hetronifly | Updated |
| 05/05/2025 | Medicine: Deltyba | Updated |
| 05/05/2025 | Medicine: mResvia | Updated |
| 05/05/2025 | Document: European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 5 | New |
| 05/05/2025 | Event: CVMP Interested Parties’ meeting May 2025 | New |
| 05/05/2025 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
| 05/05/2025 | Document: New product information wording: extracts from PRAC recommendations on signals adopted at the 7-10 April 2025 PRAC | New |
| 05/05/2025 | Document: PRAC recommendations on signals adopted at the 7-10 April 2025 meeting | New |
| 05/05/2025 | Medicine: Ecansya (previously Capecitabine Krka) | Updated |
| 05/05/2025 | Medicine: Stoboclo | Updated |
| 05/05/2025 | Medicine: Capecitabine Accord | Updated |
| 02/05/2025 | Medicine: NeoRecormon | Updated |
| 02/05/2025 | Medicine: Nuvaxovid | Updated |
| 02/05/2025 | Page: Emergency Task Force (ETF) documents | Updated |
| 02/05/2025 | Document: PRAC-ETF considerations on the use of Ixchiq live attenuated virus vaccine against chikungunya | New |
| 02/05/2025 | Medicine: Capecitabine Medac | Updated |
| 02/05/2025 | Medicine: Xeloda | Updated |
| 02/05/2025 | Medicine: Eptifibatide Accord | Updated |
| 02/05/2025 | Medicine: Levetiracetam Sun | Updated |
| 02/05/2025 | Medicine: Fintepla | Updated |
| 02/05/2025 | Medicine: Beyfortus | Updated |
| 02/05/2025 | Medicine: Bekemv | Updated |
| 02/05/2025 | Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) | Updated |
| 02/05/2025 | Medicine: Alprolix | Updated |
| 02/05/2025 | Medicine: Pirsue | Updated |
| 02/05/2025 | Medicine: Segluromet | Updated |
| 02/05/2025 | Document: Agenda of the HMPC meeting 5-7 May 2025 | New |
| 02/05/2025 | Medicine: Lyrica | Updated |
| 02/05/2025 | Medicine: Lynozyfic | Updated |
| 02/05/2025 | Medicine: Piqray | Updated |
| 02/05/2025 | Medicine: Deferasirox Mylan | Updated |
| 02/05/2025 | Medicine: Opdivo | Updated |
| 02/05/2025 | Page: Handling competing interests | Updated |
| 02/05/2025 | Page: Data protection and privacy at EMA | Updated |
| 02/05/2025 | Page: Regulatory acceptance of new approach methodologies (NAMs) to reduce animal use testing | New |
| 02/05/2025 | Page: SME Regulation and reports | Updated |
| 02/05/2025 | Document: Small and medium-sized enterprise (SME) office annual report 2024 | New |
| 01/05/2025 | Document: Policy 58: European Medicines Agency policy on the handling of competing interests of Management Board members | Updated |
| 01/05/2025 | Document: Policy 44: European Medicines Agency policy on the handling of competing interests of scientific committees’ members and experts | Updated |
