| 25/03/2025 | Medicine: Emadine | Updated |
| 25/03/2025 | Medicine: Comirnaty | Updated |
| 25/03/2025 | Medicine: Abrysvo | Updated |
| 25/03/2025 | Medicine: Amvuttra | Updated |
| 25/03/2025 | Medicine: Zabdeno | Updated |
| 25/03/2025 | Medicine: Ocrevus | Updated |
| 25/03/2025 | Medicine: EndolucinBeta | Updated |
| 25/03/2025 | Medicine: Sugammadex Fresenius Kabi | Updated |
| 25/03/2025 | Document: Annual list of grants 2024 | New |
| 25/03/2025 | Event: Second EMA / Alliance for Regenerative Medicine bilateral meeting | New |
| 25/03/2025 | Document: CTIS newsflash - 25 March 2025 | New |
| 25/03/2025 | Medicine: Prasugrel Viatris (previously Prasugrel Mylan) | Updated |
| 25/03/2025 | PIP: EMEA-002945-PIP03-23 - paediatric investigation plan | New |
| 25/03/2025 | Document: European Medicines Agency procedural advice on recommendations on unforeseen variations according to Article 5 of Commission Regulation (EC) No 1234/2008 | Updated |
| 25/03/2025 | Page: Notifying a change of marketing status | Updated |
| 25/03/2025 | PIP: EMEA-002886-PIP02-23 - paediatric investigation plan | New |
| 25/03/2025 | Page: Periodic safety update reports (PSURs) | Updated |
| 25/03/2025 | Page: Post-authorisation safety studies (PASS) | Updated |
| 25/03/2025 | Medicine: Sugammadex Amomed | Updated |
| 25/03/2025 | Medicine: Onpattro | Updated |
| 25/03/2025 | Page: Grouping of variations: questions and answers | Updated |
| 25/03/2025 | Page: Worksharing: questions and answers | Updated |
| 25/03/2025 | Page: Extensions of marketing authorisations: questions and answers | Updated |
| 25/03/2025 | Page: Type-II variations: questions and answers | Updated |
| 25/03/2025 | Page: Type-IB variations: questions and answers | Updated |
| 25/03/2025 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure | Updated |
| 25/03/2025 | Document: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes | Updated |
| 25/03/2025 | Page: Type-IA variations: questions and answers | Updated |
| 25/03/2025 | Page: Pre-authorisation guidance | Updated |
| 25/03/2025 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure | Updated |
| 25/03/2025 | Document: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes | Updated |
| 25/03/2025 | Page: Guidance on the application of the amended Variations Regulation from 1 January 2025 | Updated |
| 25/03/2025 | Medicine: Mvabea | Updated |
| 25/03/2025 | Document: Agenda - PDCO agenda of the 25-28 March 2025 meeting | New |
| 25/03/2025 | Event: Webinar on reflection paper on the qualification of non-mutagenic impurities | Updated |
| 25/03/2025 | Document: Minutes of the CVMP meeting 11-12 February 2025 | New |
| 25/03/2025 | PIP: EMEA-002796-PIP01-20-M02 - paediatric investigation plan | Updated |
| 25/03/2025 | Event: EMA multi-stakeholder workshop on reporting and qualification of mechanistic models for regulatory assessment | New |
| 25/03/2025 | PIP: EMEA-002744-PIP01-19-M01 - paediatric investigation plan | Updated |
| 25/03/2025 | PIP: EMEA-002342-PIP02-18-M03 - paediatric investigation plan | Updated |
| 25/03/2025 | PIP: EMEA-002734-PIP01-19-M01 - paediatric investigation plan | Updated |
| 24/03/2025 | Medicine: Xeljanz | Updated |
| 24/03/2025 | PIP: EMEA-002342-PIP01-18-M04 - paediatric investigation plan | Updated |
| 24/03/2025 | PIP: EMEA-000877-PIP03-17-M05 - paediatric investigation plan | Updated |
| 24/03/2025 | Page: Paediatric investigation plans: questions and answers | Updated |
| 24/03/2025 | Medicine: Seladelpar Gilead | Updated |
| 24/03/2025 | Medicine: Siiltibcy | Updated |
| 24/03/2025 | PIP: EMEA-000574-PIP03-23 - paediatric investigation plan | New |
| 24/03/2025 | Document: PhV non-compliance notification contact points at National Competent Authority (NCA) level | Updated |
| 24/03/2025 | News: EMA establishes regular procedure for scientific advice on certain high-risk medical devices | Updated |
| 24/03/2025 | Event: Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations | Updated |
| 24/03/2025 | Document: QRD Form 2 and checklist for the submission of day +25 files - veterinary | Updated |
| 24/03/2025 | Document: Minutes of the CAT meeting 4-6 December 2024 | Updated |
| 24/03/2025 | Document: Annex to 24-27 March 2025 CHMP Agenda | New |
| 24/03/2025 | Document: Agenda of the CHMP meeting 24-27 March 2025 | New |
| 24/03/2025 | Medicine: Vimkunya | New |
| 24/03/2025 | Page: Medical devices | Updated |
| 24/03/2025 | Document: Pilot on advice from expert panels to manufacturers of high-risk medical devices: Interim report on the experience with the pilot from February 2023 to December 2024 | New |
| 24/03/2025 | Event: EMA Veterinary Innovation Day | Updated |
| 21/03/2025 | PIP: EMEA-001741-PIP10-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003225-PIP01-22 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003425-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003519-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003520-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | PIP: EMEA-003541-PIP01-23 - paediatric investigation plan | New |
| 21/03/2025 | Medicine: Buvidal | Updated |
| 21/03/2025 | Medicine: Veoza | Updated |
| 21/03/2025 | Medicine: Polivy | Updated |
| 21/03/2025 | Medicine: Drovelis | Updated |
| 21/03/2025 | Event: Q&A clinic on web-based electronic Application Form (eAF) functionalities for CAPs and non-CAPs variations | Updated |
| 21/03/2025 | Medicine: Enjaymo | Updated |
| 21/03/2025 | Orphan: EU/3/13/1170 - orphan designation for treatment of acromegaly | Updated |
| 21/03/2025 | Medicine: Mycapssa | Updated |
| 21/03/2025 | Medicine: Dupixent | Updated |
| 21/03/2025 | Page: Union Product Database: release notes | Updated |
| 21/03/2025 | Document: Release notes - production release version 1.7.2514-3 - 21 March 2025 - Veterinary Medical Products Regulation: Union Product Database | New |
| 21/03/2025 | Document: Mandate, objectives and rules of procedure for the CVMP Pharmacovigilance Working Party (PhVWP-V) | Updated |
| 21/03/2025 | Event: 3Rs Working Party (3RsWP) plenary meeting - Public session on the 2025-2027 work plan | Updated |
| 20/03/2025 | Document: 2024 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission | New |
| 20/03/2025 | PSUSA: PSUSA/00000329/202407 - periodic safety update report single assessment | New |
| 20/03/2025 | Medicine: Humira | Updated |
| 20/03/2025 | Medicine: Mounjaro | Updated |
| 20/03/2025 | Medicine: Constella | Updated |
| 20/03/2025 | Medicine: Prevenar 13 | Updated |
| 20/03/2025 | Medicine: Sivextro | Updated |
| 20/03/2025 | Medicine: Scintimun | Updated |
| 20/03/2025 | Event: EMA workshop on the challenges in drug development, regulation and clinical practice for immunoglobulins | Updated |
| 20/03/2025 | Event: Certificates Processing System: Demo & Q&A session for industry stakeholders | Updated |
| 20/03/2025 | Document: Minutes of the HMPC meeting 20-22 January 2025 | New |
| 20/03/2025 | News: EMA qualifies first artificial intelligence tool to diagnose inflammatory liver disease (MASH) in biopsy samples | New |
| 20/03/2025 | Page: Opinions and letters of support on the qualification of novel methodologies for medicine development | Updated |
| 20/03/2025 | DHPC: Emblaveo - direct healthcare professional communication (DHPC) | New |
| 20/03/2025 | Medicine: Idefirix | Updated |
| 20/03/2025 | Medicine: Voxzogo | Updated |
| 19/03/2025 | Medicine: Namuscla | Updated |
| 19/03/2025 | Medicine: Pomalidomide Krka | Updated |
| 19/03/2025 | PSUSA: PSUSA/00010511/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | Medicine: Tenofovir disoproxil Zentiva | Updated |
| 19/03/2025 | Medicine: Leflunomide ratiopharm | Updated |
| 19/03/2025 | Medicine: Jayempi | Updated |
| 19/03/2025 | Medicine: Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) | Updated |
| 19/03/2025 | Medicine: Tolura | Updated |
| 19/03/2025 | Medicine: Rivastigmine Actavis | Updated |
| 19/03/2025 | Medicine: Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 19/03/2025 | Medicine: Rasagiline ratiopharm | Updated |
| 19/03/2025 | PSUSA: PSUSA/00002944/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | Medicine: Fymskina | Updated |
| 19/03/2025 | PSUSA: PSUSA/00002087/202407 - periodic safety update report single assessment | New |
| 19/03/2025 | PSUSA: PSUSA/00000081/202408 - periodic safety update report single assessment | New |
| 19/03/2025 | PIP: EMEA-003149-PIP01-21-M02 - paediatric investigation plan | Updated |
| 19/03/2025 | Event: Webinar on PMS Project Made Easy: Summary of activities and Practical Tips for SMEs | Updated |
| 19/03/2025 | Document: Medicinal products for human use: monthly figures - February 2025 | New |
| 19/03/2025 | Document: QRD statements for metered dose inhalers containing fluorinated greenhouse gases | Updated |
| 19/03/2025 | Document: 2024 European Medicines Agency annual report on independence | New |
| 19/03/2025 | Page: Applying for marketing authorisation: orphan medicines | Updated |
| 18/03/2025 | Medicine: Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva | Updated |
| 18/03/2025 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
| 18/03/2025 | EU-M4all: Ivermectin/Albendazole - opinion on medicine for use outside EU | Updated |
| 18/03/2025 | Medicine: Lenvima | Updated |
| 18/03/2025 | Medicine: Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.) | Updated |
| 18/03/2025 | Page: Variations requiring assessment (veterinary medicines) | Updated |
| 18/03/2025 | PIP: EMEA-000410-PIP01-08-M06 - paediatric investigation plan | Updated |
| 18/03/2025 | Document: Agenda of the CAT meeting 19-21 March 2025 | New |
| 18/03/2025 | Page: ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline | Updated |
| 18/03/2025 | Document: ICH M11 Technical Specification - Updated step 2b | New |
| 18/03/2025 | Event: Product Management Service (PMS) webinar : Unlocking Integration – MAH & Software Developers to explore PMS API Machine-to-Machine Connection | Updated |
| 18/03/2025 | Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 | Updated |
| 18/03/2025 | PIP: EMEA-003514-PIP02-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003514-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003504-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | PIP: EMEA-003438-PIP02-23 - paediatric investigation plan | New |
| 18/03/2025 | News: Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028 | New |
| 18/03/2025 | Document: Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (final) | New |
| 18/03/2025 | Document: Analysis and summaries of public consultation results: The European medicines agencies network strategy to 2028 | New |
| 18/03/2025 | PIP: EMEA-003426-PIP01-23 - paediatric investigation plan | New |
| 18/03/2025 | Event: EMA traineeship programme informative session | New |
| 17/03/2025 | Medicine: Leucofeligen FeLV/RCP | Updated |
| 17/03/2025 | Medicine: Cimalgex | Updated |
| 17/03/2025 | Medicine: Cytopoint | Updated |
| 17/03/2025 | Medicine: Steglatro | Updated |
| 17/03/2025 | Medicine: Skilarence | Updated |
| 17/03/2025 | Medicine: Cejemly | Updated |
| 17/03/2025 | Event: European Organisation for Research and Treatment of Cancer (EORTC) bilateral meeting | New |
| 17/03/2025 | Medicine: Lazcluze | Updated |
| 17/03/2025 | Medicine: Yervoy | Updated |
| 17/03/2025 | PIP: EMEA-003389-PIP01-23 - paediatric investigation plan | New |
| 17/03/2025 | Document: 2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG) | Updated |
| 17/03/2025 | Medicine: Uptravi | Updated |
| 17/03/2025 | PIP: EMEA-003300-PIP01-22 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002951-PIP02-21 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002817-PIP05-23 - paediatric investigation plan | New |
| 17/03/2025 | PIP: EMEA-002618-PIP04-23 - paediatric investigation plan | New |
| 17/03/2025 | Page: Methylphenidate product-specific bioequivelance guidance | New |
| 17/03/2025 | Medicine: Opdivo | Updated |
| 17/03/2025 | PIP: EMEA-002600-PIP03-21-M01 - paediatric investigation plan | Updated |
| 17/03/2025 | PIP: EMEA-002582-PIP03-23 - paediatric investigation plan | New |
| 17/03/2025 | Page: Assessment templates and guidance | Updated |
| 17/03/2025 | Event: Finding clinical trials with the ACT EU Trial Map | Updated |
| 17/03/2025 | Document: List of signals discussed at PRAC since September 2012 | Updated |
| 17/03/2025 | Document: PRAC recommendations on signals adopted at the 10-13 February 2025 meeting | New |
| 14/03/2025 | Medicine: Revinty Ellipta | Updated |
| 14/03/2025 | Event: ADRA project - information session for veterinary pharmaceutical industry | Updated |
| 14/03/2025 | Page: Contacts at the European Medicines Agency | Updated |
| 14/03/2025 | Document: Template for late submission of ICSRs to EV | New |
| 14/03/2025 | PSUSA: PSUSA/00000406/202408 - periodic safety update report single assessment | New |
| 14/03/2025 | Event: European Shortages Monitoring Platform (ESMP) training on crisis and MSSG-led preparedness reporting for marketing authorisation holders (MAHs) | Updated |
| 14/03/2025 | Medicine: Prevexxion RN | Updated |
| 14/03/2025 | Document: Agenda - Management Board meeting: 13 March 2025 | Updated |
| 14/03/2025 | Medicine: Rozlytrek | Updated |
| 14/03/2025 | Page: Medicines for human use under evaluation | Updated |
| 14/03/2025 | Medicine: Mhyosphere PCV ID | Updated |
| 14/03/2025 | Medicine: Koselugo | Updated |
| 14/03/2025 | Medicine: Porcilis PCV | Updated |
| 14/03/2025 | Document: Scientific advice under Article 115(5) of Regulation (EU) 2019/6 on veterinary medicinal products, regarding the list of substances essential for the treatment of equine species and for which the withdrawal period for equine species shall be six months | Updated |
| 14/03/2025 | Medicine: mResvia | Updated |
| 14/03/2025 | PIP: EMEA-002578-PIP01-19-M01 - paediatric investigation plan | Updated |
| 14/03/2025 | Medicine: Dimethyl fumarate Accord | Updated |
| 14/03/2025 | Medicine: Yesafili | Updated |
| 14/03/2025 | Medicine: Prazivetin | New |
| 14/03/2025 | Medicine: Nobilis Multriva IBm+ND+EDS | New |
| 14/03/2025 | Medicine: Prevestrus vet | New |
| 14/03/2025 | Post-authorisation: Rheumocam - opinion on variation to marketing authorisation | New |
| 14/03/2025 | Medicine: Hepizovac | New |
| 14/03/2025 | Event: Committee for Medicinal Products for Veterinary Use (CVMP): 11-13 March 2025 | Updated |
| 14/03/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 March 2025 | New |
| 14/03/2025 | News: First vaccine against epizootic haemorrhagic disease recommended for approval | New |
| 14/03/2025 | PIP: EMEA-002566-PIP01-19-M01 - paediatric investigation plan | Updated |
| 14/03/2025 | Page: Frequently asked questions | Updated |
| 14/03/2025 | PIP: EMEA-002559-PIP09-23 - paediatric investigation plan | New |
| 14/03/2025 | Document: Frequently asked questions (FAQs): How to create, submit and withdraw a Clinical Trial Application - CTIS Training Programme - Module 10 | Updated |
| 14/03/2025 | PIP: EMEA-002451-PIP01-18-M02 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-002350-PIP01-18-M03 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-002303-PIP01-17-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | Document: User guide for micro, small and medium-sized enterprises | Updated |
| 14/03/2025 | News: EMA Management Board: highlights of March 2025 meeting | New |
| 14/03/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 March 2025 | New |
| 14/03/2025 | PIP: EMEA-002141-PIP01-17-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001949-PIP02-18-M04 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001949-PIP01-16-M06 - paediatric investigation plan | Updated |
| 14/03/2025 | PIP: EMEA-001900-PIP02-17-M08 - paediatric investigation plan | Updated |
| 14/03/2025 | Medicine: Gardasil 9 | Updated |
| 14/03/2025 | Document: Product Management Service (PMS) roadmap | Updated |
| 14/03/2025 | Medicine: Silodyx | Updated |
| 13/03/2025 | PSUSA: PSUSA/00010390/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | PSUSA: PSUSA/00010598/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | PSUSA: PSUSA/00002256/202407 - periodic safety update report single assessment | New |
| 13/03/2025 | Herbal: Oleae folium - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Cynarae folium - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Avenae herba - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Avenae fructus - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Verbasci flos - herbal medicinal product | Updated |
| 13/03/2025 | Herbal: Sambuci flos - herbal medicinal product | Updated |
| 13/03/2025 | Page: Network Portfolio | Updated |
| 13/03/2025 | PIP: EMEA-001888-PIP01-15-M02 - paediatric investigation plan | Updated |
| 13/03/2025 | PIP: EMEA-001741-PIP01-14-M07 - paediatric investigation plan | Updated |
| 13/03/2025 | Medicine: Zolsketil pegylated liposomal | Updated |
| 13/03/2025 | Event: European Shortages Monitoring (ESMP) - Question and answer clinic for marketing authorisation holders on shortage reporting via ESMP | Updated |
| 13/03/2025 | PIP: EMEA-000205-PIP02-11-M06 - paediatric investigation plan | Updated |
| 13/03/2025 | Medicine: Imraldi | Updated |
| 13/03/2025 | Medicine: Naveruclif | Updated |
| 13/03/2025 | Document: Release notes - production release version 1.7.2514 - 12 March 2025 - Veterinary Medical Products Regulation: Union Product Database | Updated |
| 13/03/2025 | PIP: EMEA-001213-PIP03-23 - paediatric investigation plan | New |
| 13/03/2025 | Document: Network Portfolio Roadmap | Updated |
| 13/03/2025 | Page: High-risk medical devices: consultation procedures and advice | Updated |
| 13/03/2025 | Document: List of clinical evaluation consultation procedure (CECP) opinions issued for medical devices awaiting finalisation of conformity assessment | New |
| 13/03/2025 | Document: Drug-Eluting stent (DES) - Notified Body 2265 - 10/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP) | New |
| 13/03/2025 | PIP: EMEA-000383-PIP04-23 - paediatric investigation plan | New |
| 13/03/2025 | Medicine: Entyvio | Updated |
| 13/03/2025 | News: Unregulated advanced therapy medicinal products pose serious risks to health | New |
| 13/03/2025 | Medicine: Imcivree | Updated |
| 13/03/2025 | Medicine: Xgeva | Updated |
| 13/03/2025 | Herbal: Polypodii rhizoma - herbal medicinal product | Updated |
| 13/03/2025 | News: EMA Management Board elects new chair | New |
| 13/03/2025 | Document: Agenda of the HMPC meeting 17-19 March 2025 | New |
| 13/03/2025 | Medicine: Skojoy | Updated |
| 12/03/2025 | PIP: EMEA-000309-PIP07-21-M01 - paediatric investigation plan | Updated |
| 12/03/2025 | Orphan: EU/3/20/2347 - orphan designation for treatment of neuronal ceroid lipofuscinosis | Updated |
| 12/03/2025 | Orphan: EU/3/23/2836 - orphan designation for treatment of Guillain-Barré syndrome | Updated |
| 12/03/2025 | Orphan: EU/3/16/1609 - orphan designation for treatment of autoimmune haemolytic anaemia | Updated |
| 12/03/2025 | Orphan: EU/3/22/2723 - orphan designation for treatment of ovarian cancer | Updated |
| 12/03/2025 | Orphan: EU/3/20/2247 - orphan designation for treatment of myelofibrosis | Updated |
| 12/03/2025 | Orphan: EU/3/19/2149 - orphan designation for treatment of Huntington’s disease | Updated |
| 12/03/2025 | Orphan: EU/3/11/945 - orphan designation for treatment of acute liver failure | Updated |
| 12/03/2025 | Orphan: EU/3/22/2731 - orphan designation for treatment of small cell lung cancer | Updated |
| 12/03/2025 | Orphan: EU/3/24/3011 - orphan designation for treatment of myasthenia gravis | Updated |
| 12/03/2025 | Orphan: EU/3/17/1930 - orphan designation for treatment of primary biliary cholangitis | Updated |
| 12/03/2025 | Orphan: EU/3/20/2288 - orphan designation for treatment of myelodysplastic syndromes | Updated |
| 12/03/2025 | Orphan: EU/3/15/1582 - orphan designation for treatment of acute myeloid leukaemia | Updated |
| 12/03/2025 | Herbal: Lini semen - herbal medicinal product | Updated |
| 12/03/2025 | Herbal: Urticae radix - herbal medicinal product | Updated |
| 12/03/2025 | Document: IRIS guide for applicants - How to create and submit scientific applications, for industry and individual applicants | Updated |
| 12/03/2025 | Medicine: Evusheld | Updated |
| 12/03/2025 | Medicine: Sugammadex Mylan | Updated |
| 12/03/2025 | Medicine: Yselty | Updated |
| 12/03/2025 | Medicine: Rekambys | Updated |
| 12/03/2025 | Medicine: Gencebok | Updated |
| 12/03/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 12/03/2025 | Document: Summary of the Medicine Shortages SPOC Working Party meeting on 21 January 2025 | New |
| 12/03/2025 | PIP: EMEA-003043-PIP01-21-M01 - paediatric investigation plan | Updated |
| 12/03/2025 | Medicine: Wainzua | Updated |
| 12/03/2025 | Document: CTIS newsflash - 11 March 2025 | New |
| 12/03/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 12/03/2025 | Document: Final European Union herbal monograph on Urtica dioica L.; Urtica urens L., radix - Revision 1 | Updated |
| 12/03/2025 | Document: Final list of references supporting the assessment of Urtica dioica L.; Urtica urens L., radix - Revision 1 | Updated |
| 12/03/2025 | Document: Minutes - PDCO minutes of the 28-31 January 2025 meeting | New |
| 12/03/2025 | Document: Superseded Community herbal monograph on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded opinion of the HMPC on Urtica dioica L., Urtica urens L. their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded assessment report on Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded list of references supporting the assessment of Urtica dioica L., Urtica urens L., their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Document: Superseded overview of comments received on Community herbal monograph on Urtica dioica L., Urtica urens L. their hybrids or their mixtures, radix - First version | Updated |
| 12/03/2025 | Medicine: Sarclisa | Updated |
| 12/03/2025 | Event: Management Board meeting: 13 March 2025 | Updated |
| 12/03/2025 | Event: Regulation (EU) 2024/568: Questions and answers clinic for the Human Industry stakeholders | Updated |
| 12/03/2025 | Document: Minutes of the PRAC meeting 13-16 January 2025 | New |
| 12/03/2025 | Event: Regulation (EU) 2024/568: Questions and answers clinic for the Veterinary Industry stakeholders | Updated |
| 12/03/2025 | Page: Clinical investigation of medicinal products in the treatment of depression - Scientific guideline | Updated |
| 12/03/2025 | Document: European Medicines Agency's data protection notice on the use of SNDS data for the performance of DARWIN EU® studies on incidence and prevalence of pathologies and use of drugs in the French population | New |
| 12/03/2025 | Page: Clinical investigation of medicinal products in the treatment of epileptic disorders - Scientific guideline | Updated |
| 12/03/2025 | Medicine: Vocabria | Updated |
| 12/03/2025 | Event: Quarterly System Demo - Q1 2025 | Updated |
| 11/03/2025 | Medicine: Rytelo | Updated |
| 11/03/2025 | Medicine: Paxneury | Updated |
| 11/03/2025 | Medicine: Andembry | Updated |
| 11/03/2025 | Medicine: Rybrevant | Updated |
| 11/03/2025 | Page: European Shortages Monitoring Platform (ESMP) | Updated |
| 11/03/2025 | Medicine: Uzpruvo | Updated |
| 11/03/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 11/03/2025 | Page: PRIME: priority medicines | Updated |
| 11/03/2025 | Document: List of medicines currently in PRIME scheme | Updated |
| 11/03/2025 | Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting 24-27 February 2025 | New |
| 11/03/2025 | Orphan: EU/3/25/3027 - orphan designation for treatment of follicular lymphoma | New |
| 11/03/2025 | Orphan: EU/3/15/1478 - orphan designation for treatment of Duchenne muscular dystrophy | Updated |
| 11/03/2025 | Orphan: EU/3/25/3030 - orphan designation for treatment of homocystinuria and/or methylmalonic acidaemia due to genetic defects of intracellular cobalamin processing | New |
| 11/03/2025 | Orphan: EU/3/17/1954 - orphan designation for treatment of mantle cell lymphoma | Updated |
| 11/03/2025 | Orphan: EU/3/25/3033 - orphan designation for treatment of arrhythmogenic cardiomyopathy caused by pathogenic mutations in the PKP2 gene | New |
| 11/03/2025 | Orphan: EU/3/25/3032 - orphan designation for treatment of Olmsted syndrome | New |
| 11/03/2025 | Orphan: EU/3/16/1766 - orphan designation for treatment of diffuse large B-cell lymphoma | Updated |
| 11/03/2025 | Orphan: EU/3/05/334 - orphan designation for treatment of X-linked hypohidrotic ectodermal dysplasia (Christ-Siemens-Touraine Syndrome) | Updated |
| 11/03/2025 | Orphan: EU/3/25/3035 - orphan designation for treatment of acromegaly | New |
| 11/03/2025 | Orphan: EU/3/25/3026 - orphan designation for treatment of hyperphenylalaninaemia | New |
| 11/03/2025 | Orphan: EU/3/25/3029 - orphan designation for treatment of primary sclerosing cholangitis | New |
| 11/03/2025 | Orphan: EU/3/25/3028 - orphan designation for treatment of amyotrophic lateral sclerosis | New |
| 11/03/2025 | Orphan: EU/3/25/3034 - orphan designation for treatment of adenosine deaminase 2 deficiency (DADA2) | New |
| 11/03/2025 | Medicine: Emcitate | Updated |
| 11/03/2025 | Orphan: EU/3/25/3031 - orphan designation for treatment of limb-girdle muscular dystrophy | New |
| 11/03/2025 | Shortage: Quetiapine | New |
| 11/03/2025 | Event: Cancer Medicines Forum: December 2024 | New |
| 11/03/2025 | Document: Presentation - Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases: FDA guidance (Mirat Shah) | New |
| 11/03/2025 | Document: Minutes of the Cancer Medicines Forum - December 2024 | New |
| 10/03/2025 | Medicine: Zefylti | Updated |
| 10/03/2025 | Event: Human variation electronic application form (eAF) training session and Q&A clinic | Updated |
| 10/03/2025 | Event: Q&A clinic Human variations web-based electronic Application Form (eAF) for non-CAPs | Updated |
| 10/03/2025 | Medicine: Inaqovi | Updated |
| 10/03/2025 | Medicine: Sutent | Updated |
| 10/03/2025 | Medicine: Entresto | Updated |
| 10/03/2025 | Medicine: Neparvis | Updated |
| 10/03/2025 | Medicine: Silodosin Recordati | Updated |
| 10/03/2025 | Medicine: Ofev | Updated |
| 10/03/2025 | Document: Frequently asked questions on the European Shortages Monitoring Platform (ESMP) | Updated |
| 10/03/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 March 2025 | Updated |
| 10/03/2025 | Document: Agenda of the PRAC meeting 10-13 March 2025 | New |
| 10/03/2025 | Medicine: Spikevax (previously COVID-19 Vaccine Moderna) | Updated |
| 10/03/2025 | Medicine: Blincyto | Updated |
| 10/03/2025 | Event: SPOR and XEVMPD status update webinar | Updated |
| 10/03/2025 | Document: Agenda of the CVMP meeting 11-13 March 2025 | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) open Application Programming Interface (API) specifications for the ESMP API for national competent authorities (NCAs) (JSON) (YAML) | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) Application Programming Interface (API) specifications | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) data access policy - Annex A: Data elements accessible by ESMP access level | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) data access policy | New |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for national competent authorities | Updated |
| 10/03/2025 | Medicine: Entecavir Viatris (previously Entecavir Mylan) | Updated |
| 10/03/2025 | Page: Veterinary product information (QRD) templates | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders | Updated |
| 10/03/2025 | Document: European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders | Updated |
| 07/03/2025 | PSUSA: PSUSA/00010199/202405 - periodic safety update report single assessment | New |
| 07/03/2025 | PSUSA: PSUSA/00001761/202404 - periodic safety update report single assessment | New |
| 07/03/2025 | PSUSA: PSUSA/00000048/202406 - periodic safety update report single assessment | New |
| 07/03/2025 | Page: Plasma master file certificates | Updated |
| 07/03/2025 | PIP: EMEA-003470-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Herbal: Urticae herba - herbal medicinal product | Updated |
| 07/03/2025 | Document: Final European Union herbal monograph on Urtica dioica L.; Urtica urens L., herba - Revision 1 | Updated |
| 07/03/2025 | Medicine: Pedea | Updated |
| 07/03/2025 | Document: Minutes of the CHMP meeting on 14-17 October 2024 | New |
| 07/03/2025 | Orphan: EU/3/08/579 - orphan designation for corneal lesions, with associated corneal (limbal) stem cell deficiency, due to ocular burns | Updated |
| 07/03/2025 | Medicine: Holoclar | Updated |
| 07/03/2025 | Medicine: Bridion | Updated |
| 07/03/2025 | Medicine: Ibrance | Updated |
| 07/03/2025 | Medicine: Verzenios | Updated |
| 07/03/2025 | Medicine: BeneFIX | Updated |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - March 2025 | New |
| 07/03/2025 | Event: Q&A clinic on human variations web-based electronic application form (eAF) | Updated |
| 07/03/2025 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
| 07/03/2025 | Event: Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs | Updated |
| 07/03/2025 | Event: Info session on web-based electronic Application Form (eAF) add package | Updated |
| 07/03/2025 | PIP: EMEA-003476-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - June 2025 | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025 | New |
| 07/03/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - April 2025 | New |
| 07/03/2025 | Medicine: Nobilis Multriva REOm | Updated |
| 07/03/2025 | PIP: EMEA-003475-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Kimmtrak | Updated |
| 07/03/2025 | Medicine: Brinavess | Updated |
| 07/03/2025 | PIP: EMEA-001911-PIP02-22 - paediatric investigation plan | New |
| 07/03/2025 | PIP: EMEA-003498-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Truqap | Updated |
| 07/03/2025 | Medicine: Supemtek Tetra (previously Supemtek) | Updated |
| 07/03/2025 | Medicine: Equilis Prequenza | Updated |
| 07/03/2025 | PIP: EMEA-003466-PIP01-23 - paediatric investigation plan | New |
| 07/03/2025 | Medicine: Recarbrio | Updated |
| 07/03/2025 | Medicine: Equilis Te | Updated |
| 07/03/2025 | Page: COVID-19 medicines | Updated |
| 07/03/2025 | Medicine: Equilis Prequenza Te | Updated |
| 07/03/2025 | Document: Minutes of the CHMP meeting 11-14 November 2024 | New |
| 07/03/2025 | Event: Clinical Trials Information System (CTIS) bitesize talk: Change of sponsor in CTIS | Updated |
| 07/03/2025 | Page: Website outages and upgrades | Updated |
| 07/03/2025 | Document: List of withdrawn medicinal products in accordance with Art. 123(4) of the Directive (1 January - 31 December 2024) | Updated |
| 06/03/2025 | PIP: EMEA-003238-PIP02-22 - paediatric investigation plan | New |
| 06/03/2025 | PIP: EMEA-003237-PIP02-22 - paediatric investigation plan | New |
| 06/03/2025 | Medicine: Hexyon | Updated |
| 06/03/2025 | Medicine: Rybelsus | Updated |
| 06/03/2025 | Medicine: Eltrombopag Viatris | Updated |
| 06/03/2025 | Medicine: Ulunar Breezhaler | Updated |
| 06/03/2025 | PSUSA: PSUSA/00010483/202406 - periodic safety update report single assessment | New |
| 06/03/2025 | Medicine: Tygacil | Updated |
| 06/03/2025 | Medicine: Pregabalin Viatris (previously Pregabalin Mylan) | Updated |
| 06/03/2025 | PIP: EMEA-000402-PIP03-17-M08 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000325-PIP01-08-M11 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000128-PIP02-09-M05 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-000016-PIP01-07-M09 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-002963-PIP01-21-M01 - paediatric investigation plan | Updated |
| 06/03/2025 | PIP: EMEA-002950-PIP01-20-M01 - paediatric investigation plan | Updated |
| 06/03/2025 | Medicine: Yorvipath | Updated |
| 06/03/2025 | PIP: EMEA-001032-PIP01-10-M07 - paediatric investigation plan | Updated |
| 06/03/2025 | Medicine: Bemrist Breezhaler | Updated |
| 06/03/2025 | Medicine: Atectura Breezhaler | Updated |
| 06/03/2025 | Medicine: Sitagliptin / Metformin hydrochloride Mylan | Updated |
| 05/03/2025 | Medicine: Hexacima | Updated |
| 05/03/2025 | Medicine: Dynastat | Updated |
| 05/03/2025 | Medicine: Cimzia | Updated |
| 05/03/2025 | Medicine: Zimbus Breezhaler | Updated |
| 05/03/2025 | Medicine: Quofenix | Updated |
| 05/03/2025 | Medicine: Enerzair Breezhaler | Updated |
| 05/03/2025 | Medicine: Benepali | Updated |
| 05/03/2025 | Medicine: Neoclarityn | Updated |
| 05/03/2025 | Medicine: Azomyr | Updated |
| 05/03/2025 | Medicine: Aerius | Updated |
| 05/03/2025 | Referral: Azithromycin-containing medicinal products for systemic use - referral | Updated |
| 05/03/2025 | Document: List of European Union reference dates (EURD) and frequency of submission of periodic safety update reports (PSURs) | Updated |
| 05/03/2025 | Medicine: Syvazul BTV 3 | Updated |
| 05/03/2025 | Medicine: Bluevac-3 | Updated |
| 05/03/2025 | Medicine: Skyrizi | Updated |
| 05/03/2025 | Medicine: Lenalidomide Mylan | Updated |
| 05/03/2025 | Event: Union product database: webinar for veterinary marketing authorisation holders on an industry dedicated read API | Updated |
| 05/03/2025 | Document: Annex to 24-27 February 2025 CHMP Agenda | Updated |
| 05/03/2025 | Document: Frequently asked questions (FAQs) : How to create and submit an annual safety report and respond to related requests for information - CTIS Training Programme - Module 18 | Updated |
| 05/03/2025 | Document: Minutes - PDCO minutes of the 12-15 November 2024 meeting | Updated |
| 05/03/2025 | Medicine: Remsima | Updated |
| 05/03/2025 | Page: CHMP opinions on consultation procedures | Updated |
| 05/03/2025 | Document: Vitrolife IVF media - Procedural steps and scientific information after initial consultation | Updated |
| 05/03/2025 | Medicine: Eylea | Updated |
| 05/03/2025 | Medicine: Tarceva | Updated |
| 05/03/2025 | Medicine: Awiqli | Updated |
| 05/03/2025 | Medicine: Alimta | Updated |
| 05/03/2025 | Medicine: Inrebic | Updated |
| 05/03/2025 | Medicine: ReFacto AF | Updated |
| 04/03/2025 | Medicine: Viagra | Updated |
| 04/03/2025 | Medicine: Ibandronic acid Accord | Updated |
| 04/03/2025 | Medicine: Coagadex | Updated |
| 04/03/2025 | Medicine: Toviaz | Updated |
| 04/03/2025 | Medicine: SomaKit TOC | Updated |
| 04/03/2025 | Document: New product information wording – Extracts from PRAC recommendations on signals adopted at the 28-31 October 2024 PRAC | Updated |
| 04/03/2025 | Medicine: Ryzodeg | Updated |
| 04/03/2025 | Medicine: Viramune | Updated |
| 04/03/2025 | PIP: EMEA-002727-PIP02-23 - paediatric investigation plan | New |
| 04/03/2025 | Medicine: Skyclarys | Updated |
| 04/03/2025 | Medicine: Lutathera | Updated |
| 04/03/2025 | PIP: EMEA-003484-PIP01-23 - paediatric investigation plan | New |
| 04/03/2025 | Medicine: Baiama | Updated |
| 04/03/2025 | Medicine: Mirvaso | Updated |
| 03/03/2025 | PSUSA: PSUSA/00002943/202406 - periodic safety update report single assessment | New |
| 03/03/2025 | Medicine: Vegzelma | Updated |
| 03/03/2025 | Medicine: Xoterna Breezhaler | Updated |
| 03/03/2025 | Medicine: Tecartus | Updated |
| 03/03/2025 | Medicine: Anagrelide Viatris (previously Anagrelide Mylan) | Updated |
| 03/03/2025 | Event: European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties joint meeting | Updated |
| 03/03/2025 | Medicine: Orserdu | Updated |
| 03/03/2025 | Medicine: Ultibro Breezhaler | Updated |
| 03/03/2025 | Medicine: Obodence | Updated |
| 03/03/2025 | Medicine: Nepexto | Updated |
| 03/03/2025 | Medicine: Beyonttra | Updated |
| 03/03/2025 | News: New clinical trial map launched in the EU | New |
| 03/03/2025 | Page: Clinical Trials Information System | Updated |
| 03/03/2025 | Document: Regulatory Procedure Management (RPM) for the Product Lifecycle Management (PLM) - Frequently asked questions | Updated |
| 03/03/2025 | Medicine: Spherox | Updated |
| 03/03/2025 | Medicine: Efient | Updated |
| 03/03/2025 | Medicine: Litfulo | Updated |
| 03/03/2025 | Medicine: Atazanavir Viatris (previously Atazanavir Mylan) | Updated |
| 03/03/2025 | Medicine: Pyzchiva | Updated |
| 03/03/2025 | Medicine: MenQuadfi | Updated |
| 03/03/2025 | Medicine: Ruconest | Updated |
| 03/03/2025 | Medicine: Clopidogrel / Acetylsalicylic acid Viatris (previously Clopidogrel / Acetylsalicylic acid Mylan) | Updated |
| 03/03/2025 | Medicine: Modigraf | Updated |
| 03/03/2025 | Event: Clinical Trials Information System (CTIS) bitesize talk: End of transition period and notifications including serious breach | Updated |
| 03/03/2025 | Event: Clinical Trials Information System (CTIS) Bitesize Talk: Revised transparency rules and the new CTIS public portal | Updated |
| 03/03/2025 | Medicine: Torisel | Updated |
| 03/03/2025 | Page: Procurement | Updated |