| 28/02/2025 | Document: Infectious Diseases Working Party (IDWP) consolidated 3-year rolling work plan 2025-2027 | Updated |
| 28/02/2025 | Event: European Shortages Monitoring Platform (ESMP) workshop on application programming interface (API) for marketing authorisation holders (MAHs) | New |
| 28/02/2025 | Page: Reliance for post-authorisation changes: pilots for the pharmaceutical industry | New |
| 28/02/2025 | Event: Training on human variations web-based electronic application form (eAF) functionalities for CAPs and non-CAPs variations | Updated |
| 28/02/2025 | Event: Certificates Processing System: Demo & Q&A session for Industry stakeholders (H+V) | New |
| 28/02/2025 | Medicine: Envarsus | Updated |
| 28/02/2025 | Herbal: Eucalypti aetheroleum - herbal medicinal product | Updated |
| 28/02/2025 | Page: Nitrosamine impurities in specific medicines | Updated |
| 28/02/2025 | Page: Procedures for monograph and list entry establishment | Updated |
| 28/02/2025 | Herbal: Betulae folium - herbal medicinal product | Updated |
| 28/02/2025 | Herbal: Eleutherococci radix - herbal medicinal product | Updated |
| 28/02/2025 | Herbal: Passiflorae herba - herbal medicinal product | Updated |
| 28/02/2025 | Herbal: Hederae helicis folium - herbal medicinal product | Updated |
| 28/02/2025 | Post-authorisation: Tremfya - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Dupixent - withdrawal of application for variation to marketing authorisation | New |
| 28/02/2025 | Medicine: Rilonacept FGK Representative Service GmbH | New |
| 28/02/2025 | Post-authorisation: Bimervax - withdrawal of application for variation to marketing authorisation | New |
| 28/02/2025 | Medicine: Trabectedin Accord | New |
| 28/02/2025 | Post-authorisation: Kaftrio - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Kalydeco - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Columvi - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Abrysvo - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Supemtek Tetra (previously Supemtek) - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Prevymis - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Rinvoq - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Keytruda - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Medicine: Leqembi | New |
| 28/02/2025 | Medicine: Vyjuvek | New |
| 28/02/2025 | Post-authorisation: Ixchiq - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Medicine: Deqsiga | New |
| 28/02/2025 | Medicine: Lynozyfic | New |
| 28/02/2025 | Post-authorisation: Enhertu - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Calquence - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Fabhalta - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Jaypirca - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Medicine: Kizfizo | Updated |
| 28/02/2025 | Post-authorisation: Stelara - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Darzalex - opinion on variation to marketing authorisation | New |
| 28/02/2025 | Post-authorisation: Imfinzi - opinion on variation to marketing authorisation | New |
| 28/02/2025 | News: Combination of cystic fibrosis medicines to treat patients with rare mutations | New |
| 28/02/2025 | News: First topical gene therapy treatment for dystrophic epidermolysis bullosa | New |
| 28/02/2025 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2025 | New |
| 28/02/2025 | Document: List of centrally authorised products with safety-related changes to the product information | Updated |
| 28/02/2025 | Document: Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004 | Updated |
| 28/02/2025 | Medicine: Fluenz | Updated |
| 28/02/2025 | Page: Orphan designation: Overview | Updated |
| 28/02/2025 | Document: Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2 | New |
| 28/02/2025 | Page: Clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Scientific guideline | Updated |
| 27/02/2025 | Document: Minutes of the CAT meeting 22-24 January 2025 | New |
| 27/02/2025 | Medicine: Nuvaxovid | Updated |
| 27/02/2025 | Medicine: Advagraf | Updated |
| 27/02/2025 | Medicine: Omlyclo | Updated |
| 27/02/2025 | Medicine: Remicade | Updated |
| 27/02/2025 | Medicine: Welireg | Updated |
| 27/02/2025 | Document: Infographic - Orphan Medicines in the EU | Updated |
| 27/02/2025 | Document: Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations | Updated |
| 27/02/2025 | Medicine: Zavicefta | Updated |
| 27/02/2025 | Medicine: Soliris | Updated |
| 27/02/2025 | Medicine: Xalkori | Updated |
| 27/02/2025 | Medicine: Spinraza | Updated |
| 27/02/2025 | Document: Clinical Trial Information System (CTIS) evaluation timelines | Updated |
| 27/02/2025 | Medicine: Voydeya | Updated |
| 27/02/2025 | Medicine: Evkeeza | Updated |
| 27/02/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 27/02/2025 | Medicine: Biktarvy | Updated |
| 27/02/2025 | Medicine: Fasenra | Updated |
| 27/02/2025 | Medicine: Somavert | Updated |
| 26/02/2025 | Medicine: Wezenla | Updated |
| 26/02/2025 | Medicine: Steqeyma | Updated |
| 26/02/2025 | Document: Annex - National provisions for SMEs applicable to the pharmaceutical sector | Updated |
| 26/02/2025 | Medicine: Kostaive | New |
| 26/02/2025 | Medicine: Micardis | Updated |
| 26/02/2025 | Event: Joint EC/HMA/EMA multi-stakeholder workshop on pharmacogenomics | Updated |
| 26/02/2025 | Medicine: Fampridine Accord | Updated |
| 26/02/2025 | Medicine: Herzuma | Updated |
| 26/02/2025 | Medicine: ProQuad | Updated |
| 26/02/2025 | Medicine: GeGant | Updated |
| 26/02/2025 | Medicine: Sunlenca | Updated |
| 26/02/2025 | Medicine: Sitagliptin SUN | Updated |
| 26/02/2025 | Medicine: Aripiprazole Accord | Updated |
| 26/02/2025 | Medicine: MicardisPlus | Updated |
| 26/02/2025 | Page: ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline | Updated |
| 26/02/2025 | Page: Investigation of bioequivalence - Scientific guideline | Updated |
| 26/02/2025 | Medicine: Bimervax | Updated |
| 26/02/2025 | Medicine: Eklira Genuair | Updated |
| 26/02/2025 | Page: Clinical evaluation of new vaccines - Scientific guideline | Updated |
| 26/02/2025 | Medicine: Duaklir Genuair | Updated |
| 26/02/2025 | Medicine: Giotrif | Updated |
| 26/02/2025 | Document: Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals | Updated |
| 26/02/2025 | Herbal: Pilosellae herba cum radice - herbal medicinal product | Updated |
| 26/02/2025 | Document: Agenda - PDCO agenda of the 25-28 February 2025 meeting | New |
| 26/02/2025 | PIP: EMEA-003063-PIP02-22 - paediatric investigation plan | Updated |
| 26/02/2025 | PIP: EMEA-000786-PIP01-09-M02 - paediatric investigation plan | Updated |
| 25/02/2025 | Medicine: Xtandi | Updated |
| 25/02/2025 | Document: Medicinal products for human use: monthly figures - January 2025 | New |
| 25/02/2025 | Document: CTIS newsflash - 25 February 2025 | New |
| 25/02/2025 | Medicine: Stelara | Updated |
| 25/02/2025 | Event: ACT EU workshop on ICH E6 R3 (principles and Annex 1) | Updated |
| 25/02/2025 | Medicine: Brimica Genuair | Updated |
| 25/02/2025 | Medicine: Eptifibatide Accord | Updated |
| 25/02/2025 | Medicine: Bretaris Genuair | Updated |
| 25/02/2025 | Medicine: Trumenba | Updated |
| 25/02/2025 | Medicine: Tacforius | Updated |
| 25/02/2025 | Medicine: Carvykti | Updated |
| 25/02/2025 | PSUSA: PSUSA/00000434/202407 - periodic safety update report single assessment | New |
| 25/02/2025 | Medicine: Pregabalin Pfizer | Updated |
| 25/02/2025 | Page: Questions and answers for biological medicinal products | Updated |
| 25/02/2025 | Herbal: Tribuli terrestris herba - herbal medicinal product | Updated |
| 25/02/2025 | Herbal: Prunus avium peduncle - herbal medicinal product | Updated |
| 24/02/2025 | Medicine: Poulvac Procerta HVT-IBD-ND | Updated |
| 24/02/2025 | Medicine: Icthiovac ERM | Updated |
| 24/02/2025 | Medicine: Breyanzi | Updated |
| 24/02/2025 | Page: List of medicines under additional monitoring | Updated |
| 24/02/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 24/02/2025 | Document: List of medicinal products under additional monitoring | Updated |
| 24/02/2025 | Medicine: Lyrica | Updated |
| 24/02/2025 | Medicine: Kavigale | Updated |
| 24/02/2025 | Page: EU Innovation Network (EU-IN) | Updated |
| 24/02/2025 | Document: New Approach Methodologies EU-IN Horizon Scanning Report | New |
| 24/02/2025 | Document: Agenda of the CHMP meeting 24-27 February 2025 | New |
| 24/02/2025 | Medicine: Relvar Ellipta | Updated |
| 24/02/2025 | Page: Good distribution practice | Updated |
| 24/02/2025 | Page: Good manufacturing practice | Updated |
| 24/02/2025 | Page: Development of the Clinical Trials Information System | Updated |
| 24/02/2025 | Page: Clinical Trials Information System (CTIS): training and support | Updated |
| 24/02/2025 | Document: Marketing authorisation application (MAA) - pre-submission interactions form | Updated |
| 24/02/2025 | Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications | Updated |
| 24/02/2025 | Document: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal products applications: document with track changes | Updated |
| 24/02/2025 | Orphan: EU/3/24/3020 - orphan designation for inherited retinal dystrophy due to defects in the RPE65 gene | New |
| 24/02/2025 | Orphan: EU/3/22/2721 - orphan designation for treatment of biliary tract cancer | Updated |
| 24/02/2025 | Medicine: Avastin | Updated |
| 24/02/2025 | Orphan: EU/3/24/3014 - orphan designation for treatment of acute promyelocytic leukaemia | Updated |
| 24/02/2025 | Page: Biosimilar medicines: marketing authorisation | Updated |
| 24/02/2025 | Orphan: EU/3/18/2115 - orphan designation for treatment of spinal muscular atrophy | Updated |
| 24/02/2025 | Orphan: EU/3/10/823 - orphan designation for treatment of familial chylomicronaemia | Updated |
| 24/02/2025 | Orphan: EU/3/21/2459 - orphan designation for treatment of familial chylomicronaemia syndrome | Updated |
| 24/02/2025 | DHPC: Kisqali - direct healthcare professional communication (DHPC) | New |
| 21/02/2025 | Page: World Health Organization (WHO) | Updated |
| 21/02/2025 | Page: Infectious Diseases Working Party | Updated |
| 21/02/2025 | Page: Oncology Working Party | Updated |
| 21/02/2025 | Document: Consolidated 3-year rolling work plan for the Oncology Working Party : January 2025 - December 2027 | Updated |
| 21/02/2025 | Page: Funding | Updated |
| 21/02/2025 | Document: Agenda of the COMP meeting 3-5 December 2024 | Updated |
| 21/02/2025 | Document: Minutes of the COMP meeting 3-5 December 2024 | Updated |
| 21/02/2025 | Document: Agenda of the COMP meeting 21-23 January 2025 | Updated |
| 21/02/2025 | Document: Heading and text to be inserted in Section 5.1 of the SmPC | Updated |
| 21/02/2025 | Document: Minimum inhibitory concentration (MIC) breakpoints | Updated |
| 21/02/2025 | Document: Substances considered as not falling within the scope of Regulation (EC) No. 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin | Updated |
| 21/02/2025 | Page: Demonstration of efficacy for veterinary medicinal products containing antimicrobial substances - Scientific guideline | Updated |
| 21/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – February 2025 | Updated |
| 21/02/2025 | Document: Agenda – Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) 26 February 2025 | New |
| 21/02/2025 | Page: Conduct of efficacy studies for intramammary products for use in cattle - Scientific guideline | Updated |
| 21/02/2025 | Medicine: Omvoh | Updated |
| 20/02/2025 | Document: DARWIN EU data partners onboarded in phases I, II and III | Updated |
| 20/02/2025 | Medicine: Fabhalta | Updated |
| 20/02/2025 | Medicine: Victoza | Updated |
| 20/02/2025 | Page: How to recognise scams using EMA credentials | New |
| 20/02/2025 | Document: Minutes of the CVMP meeting 14-15 January 2025 | New |
| 20/02/2025 | Orphan: EU/3/24/3019 - orphan designation for treatment of autoimmune haemolytic anaemia | New |
| 20/02/2025 | Orphan: EU/3/24/3024 - orphan designation for treatment of Cushing's syndrome of endogenous origin | New |
| 20/02/2025 | Orphan: EU/3/15/1576 - orphan designation for treatment of ovarian cancer | Updated |
| 20/02/2025 | Orphan: EU/3/22/2722 - orphan designation for treatment of hereditary angioedema | Updated |
| 20/02/2025 | Orphan: EU/3/13/1196 - orphan designation for treatment of Wiskott-Aldrich syndrome | Updated |
| 20/02/2025 | Orphan: EU/3/22/2626 - orphan designation for treatment of erythromelalgia | Updated |
| 20/02/2025 | Orphan: EU/3/15/1540 - orphan designation for treatment of mucopolysaccharidosis type II (Hunter's syndrome) | Updated |
| 20/02/2025 | Orphan: EU/3/12/1095 - orphan designation for treatment of mucopolysaccharidosis type IIIB (Sanfilippo B syndrome) | Updated |
| 20/02/2025 | Orphan: EU/3/14/1257 - orphan designation for treatment of recombination-activating gene 1 deficient severe combined immunodeficiency | Updated |
| 20/02/2025 | Orphan: EU/3/23/2887 - orphan designation for treatment of recurrent respiratory papillomatosis | Updated |
| 20/02/2025 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
| 20/02/2025 | Orphan: EU/3/24/3023 - orphan designation for treatment of glycogen storage disease type IV | New |
| 20/02/2025 | Medicine: Imfinzi | Updated |
| 20/02/2025 | Orphan: EU/3/24/3017 - orphan designation for treatment of primary biliary cholangitis | New |
| 20/02/2025 | Orphan: EU/3/24/3022 - orphan designation for treatment of non-traumatic osteonecrosis | New |
| 20/02/2025 | Orphan: EU/3/24/3016 - orphan designation for treatment of soft tissue sarcoma | New |
| 20/02/2025 | Medicine: Tuznue | Updated |
| 20/02/2025 | Orphan: EU/3/24/3025 - orphan designation for treatment of gastrointestinal stromal tumours | New |
| 20/02/2025 | Orphan: EU/3/24/3015 - orphan designation for treatment of pancreatic cancer | New |
| 20/02/2025 | Orphan: EU/3/24/3018 - orphan designation for treatment of congenital alpha-1 antitrypsin deficiency | New |
| 20/02/2025 | Orphan: EU/3/24/3021 - orphan designation for treatment of chronic pancreatitis | New |
| 20/02/2025 | Medicine: Saxenda | Updated |
| 20/02/2025 | Page: Data Analysis and Real World Interrogation Network (DARWIN EU) | Updated |
| 20/02/2025 | Medicine: Sapropterin Dipharma | Updated |
| 20/02/2025 | Medicine: Yesintek | Updated |
| 20/02/2025 | Document: DARWIN EU: Making health data count | Updated |
| 20/02/2025 | Event: DARWIN EU Advisory Board meeting: 3 May 2024 | Updated |
| 20/02/2025 | Document: Minutes - DARWIN EU Advisory Board - 3 May 2024 | New |
| 20/02/2025 | Medicine: Qaialdo | Updated |
| 20/02/2025 | Medicine: Memantine Mylan | Updated |
| 20/02/2025 | Medicine: Jakavi | Updated |
| 19/02/2025 | PIP: EMEA-003501-PIP01-23 - paediatric investigation plan | New |
| 19/02/2025 | PIP: EMEA-003500-PIP01-23 - paediatric investigation plan | New |
| 19/02/2025 | PIP: EMEA-003392-PIP01-23 - paediatric investigation plan | New |
| 19/02/2025 | PIP: EMEA-003182-PIP01-22-M01 - paediatric investigation plan | Updated |
| 19/02/2025 | PIP: EMEA-003350-PIP01-23 - paediatric investigation plan | New |
| 19/02/2025 | PIP: EMEA-002904-PIP01-20-M01 - paediatric investigation plan | Updated |
| 19/02/2025 | PIP: EMEA-001195-PIP01-11-M07 - paediatric investigation plan | Updated |
| 19/02/2025 | PSUSA: PSUSA/00000434/202407 - periodic safety update report single assessment | New |
| 19/02/2025 | Medicine: Obgemsa | Updated |
| 19/02/2025 | Medicine: Zoely | Updated |
| 19/02/2025 | Medicine: Pluvicto | Updated |
| 19/02/2025 | Medicine: Vevizye | Updated |
| 19/02/2025 | Medicine: Prevenar 20 (previously Apexxnar) | Updated |
| 19/02/2025 | Medicine: Balversa | Updated |
| 19/02/2025 | Medicine: Apretude | Updated |
| 19/02/2025 | Medicine: Thyrogen | Updated |
| 19/02/2025 | Document: Clinical Trial Information System (CTIS) - Sponsor handbook | Updated |
| 19/02/2025 | Medicine: Pregabalin Sandoz | Updated |
| 19/02/2025 | Medicine: Nemluvio | Updated |
| 19/02/2025 | Page: Generic and hybrid applications | Updated |
| 19/02/2025 | Medicine: Neupro | Updated |
| 19/02/2025 | Medicine: Galvus | Updated |
| 19/02/2025 | Orphan: EU/3/17/1925 - orphan designation for treatment of multiple myeloma | Updated |
| 19/02/2025 | Medicine: Blenrep | Updated |
| 19/02/2025 | Medicine: Erbitux | Updated |
| 18/02/2025 | Medicine: Ravicti | Updated |
| 18/02/2025 | Medicine: Avamys | Updated |
| 18/02/2025 | Medicine: Ebvallo | Updated |
| 18/02/2025 | Medicine: Iclusig | Updated |
| 18/02/2025 | Medicine: Flucelvax Tetra | Updated |
| 18/02/2025 | Page: Artificial intelligence | Updated |
| 18/02/2025 | Medicine: Imjudo | Updated |
| 18/02/2025 | Medicine: Spexotras | Updated |
| 18/02/2025 | Medicine: Vyndaqel | Updated |
| 18/02/2025 | Medicine: GoResp Digihaler (previously Budesonide/Formoterol Teva Pharma B.V.) | Updated |
| 18/02/2025 | Page: Transfer of marketing authorisation: questions and answers | Updated |
| 18/02/2025 | Page: Changing the labelling and package leaflet (Article 61(3) notifications) | Updated |
| 18/02/2025 | Document: Checklist for the submission of Type IA and Type IB (without linguistic review) product information annexes and Annex A (if applicable) - human | Updated |
| 18/02/2025 | Event: European medicines agencies network strategy (EMANS) to 2028 webinar | Updated |
| 18/02/2025 | Event: Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - 4 February 2025 | Updated |
| 18/02/2025 | Document: Agenda of the CAT meeting 19-21 February 2025 | New |
| 18/02/2025 | Document: Quick guide - Introduction: CTIS for SMEs and Academia - CTIS Training Programme - Module 19 | Updated |
| 18/02/2025 | Document: Quick guide: How to search, view and download a Clinical Trial and a Clinical Trial Application (sponsors) - CTIS Training Programme - Module 09 | Updated |
| 18/02/2025 | Document: FAQs: Introduction to the Clinical Trials Regulation (EU) No 536/2014 - CTIS Training Programme - Module 01 | Updated |
| 18/02/2025 | Referral: Finasteride- and dutasteride-containing medicinal products - referral | Updated |
| 18/02/2025 | Medicine: Onureg | Updated |
| 18/02/2025 | Document: European Medicines Agency’s data protection notice regarding personal data processing in the Clinical Trials Information System (CTIS) | New |
| 18/02/2025 | Page: Maximum residue limits (MRL) | Updated |
| 18/02/2025 | Event: EMA Open Door Day | Updated |
| 18/02/2025 | Medicine: Azacitidine Accord | Updated |
| 18/02/2025 | Document: Agenda - ACT EU workshop on ICH E6 (R3) | Updated |
| 18/02/2025 | Document: Programme - EMA's Open Door Day | New |
| 17/02/2025 | PIP: EMEA-003301-PIP01-22-M01 - paediatric investigation plan | Updated |
| 17/02/2025 | PIP: EMEA-003155-PIP01-21-M01 - paediatric investigation plan | Updated |
| 17/02/2025 | PIP: EMEA-002755-PIP01-19-M02 - paediatric investigation plan | Updated |
| 17/02/2025 | PIP: EMEA-002713-PIP02-21-M01 - paediatric investigation plan | Updated |
| 17/02/2025 | Medicine: Daptomycin Hospira | Updated |
| 17/02/2025 | Medicine: Cibinqo | Updated |
| 17/02/2025 | Document: Minutes - HMA-EMA joint Big Data Steering Group teleconference - 11 December 2024 | Updated |
| 17/02/2025 | Page: International Coalition of Medicines Regulatory Authorities (ICMRA) | Updated |
| 17/02/2025 | Document: Agenda of the COMP meeting 18-19 February 2025 | New |
| 17/02/2025 | Page: Big data | Updated |
| 17/02/2025 | Event: Fifth EMA/HMA Big Data Stakeholder Forum | Updated |
| 17/02/2025 | Document: Report - HMA/EMA Big Data Stakeholder Forum 2024 | New |
| 17/02/2025 | Page: Template for a European Union herbal monograph | Updated |
| 17/02/2025 | Page: Template for assessment report for the development of European Union herbal monographs and list entries | Updated |
| 17/02/2025 | Medicine: Mekinist | Updated |
| 17/02/2025 | Page: Environmental management | New |
| 17/02/2025 | Page: Interested Parties to the HMPC | Updated |
| 17/02/2025 | 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 |
| 17/02/2025 | Document: Contact details of national competent authorities for requests of translation exemptions falling under Art. 63.3 of Directive 2001/83/EC and cases of shortages | Updated |
| 17/02/2025 | Medicine: CellCept | Updated |
| 17/02/2025 | Medicine: Piqray | Updated |
| 17/02/2025 | Medicine: Trydonis | Updated |
| 17/02/2025 | PIP: EMEA-003472-PIP01-23 - paediatric investigation plan | New |
| 17/02/2025 | Medicine: Trimbow | Updated |
| 17/02/2025 | PIP: EMEA-003471-PIP01-23 - paediatric investigation plan | New |
| 17/02/2025 | PIP: EMEA-003468-PIP01-23 - paediatric investigation plan | New |
| 17/02/2025 | PIP: EMEA-003404-PIP01-23 - paediatric investigation plan | New |
| 17/02/2025 | Medicine: Evenity | Updated |
| 17/02/2025 | News: EMA earns certification for its environmental efforts | New |
| 14/02/2025 | PIP: EMEA-002640-PIP01-19-M01 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002438-PIP02-19-M03 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002762-PIP02-20-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002198-PIP01-21-M01 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002746-PIP01-20-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001794-PIP02-16-M06 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002723-PIP01-19-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001716-PIP04-19-M01 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001625-PIP01-14-M07 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001619-PIP03-16-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001220-PIP01-11-M09 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-002360-PIP02-22-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PSUSA: PSUSA/00000789/202406 - periodic safety update report single assessment | New |
| 14/02/2025 | PSUSA: PSUSA/00000989/202406 - periodic safety update report single assessment | New |
| 14/02/2025 | PSUSA: PSUSA/00002163/202407 - periodic safety update report single assessment | New |
| 14/02/2025 | Medicine: Zinforo | Updated |
| 14/02/2025 | Medicine: Karvea | Updated |
| 14/02/2025 | PIP: EMEA-001812-PIP01-15-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | PIP: EMEA-001716-PIP07-22 - paediatric investigation plan | Updated |
| 14/02/2025 | Medicine: Paxlovid | Updated |
| 14/02/2025 | PIP: EMEA-001776-PIP02-17-M02 - paediatric investigation plan | Updated |
| 14/02/2025 | Medicine: Beyfortus | Updated |
| 14/02/2025 | PIP: EMEA-001318-PIP01-12-M05 - paediatric investigation plan | Updated |
| 14/02/2025 | Page: Union list of critical medicines | Updated |
| 14/02/2025 | Page: Substance and product data management services | Updated |
| 14/02/2025 | PIP: EMEA-003467-PIP01-23 - paediatric investigation plan | New |
| 14/02/2025 | Document: Union list of critical medicines: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Product Management System (PMS) entries (outdated) | Updated |
| 14/02/2025 | Herbal: Combination: Hyperici herba - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Valerianae radix - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Valerianae aetheroleum - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Salviae officinalis folium - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Centaurii herba - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Anisi fructus - herbal medicinal product | Updated |
| 14/02/2025 | Herbal: Anisi aetheroleum - herbal medicinal product | Updated |
| 14/02/2025 | Medicine: Elmaro | New |
| 14/02/2025 | Medicine: Omeprazole TriviumVet | New |
| 14/02/2025 | Post-authorisation: Porcilis ColiClos - opinion on variation to marketing authorisation | New |
| 14/02/2025 | Post-authorisation: Simparica Trio - opinion on variation to marketing authorisation | New |
| 14/02/2025 | Medicine: Vectormune HVT-AIV | New |
| 14/02/2025 | News: Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-12 February 2025 | New |
| 14/02/2025 | Event: Conversations on cancer - cervical cancer treatment innovation: a collaborative discussion | Updated |
| 14/02/2025 | Document: Records of data processing activity regarding the processing of personal data in the Clinical Trials Information System (CTIS) | Updated |
| 14/02/2025 | Page: Patients' and Consumers' Working Party | Updated |
| 14/02/2025 | Document: Product Management Service (PMS) – Frequently Asked Questions (FAQs) | Updated |
| 14/02/2025 | Medicine: Lyumjev (previously Liumjev) | Updated |
| 14/02/2025 | Medicine: Opfolda | Updated |
| 14/02/2025 | Document: Article 57 product data | Updated |
| 14/02/2025 | News: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 February 2025 | New |
| 14/02/2025 | Page: Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development | New |
| 14/02/2025 | Medicine: Ambrisentan Viatris (previously Ambrisentan Mylan) | Updated |
| 14/02/2025 | Event: Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system | New |
| 14/02/2025 | Document: QRD veterinary product-information highlighted template version 9.1 | Updated |
| 14/02/2025 | Document: QRD veterinary product-information template version 9.1 | Updated |
| 13/02/2025 | PSUSA: PSUSA/00010605/202407 - periodic safety update report single assessment | New |
| 13/02/2025 | PSUSA: PSUSA/00010252/202406 - periodic safety update report single assessment | New |
| 13/02/2025 | PSUSA: PSUSA/00010184/202406 - periodic safety update report single assessment | New |
| 13/02/2025 | PSUSA: PSUSA/00009236/202406 - periodic safety update report single assessment | New |
| 13/02/2025 | Medicine: Bortezomib Fresenius Kabi | Updated |
| 13/02/2025 | PSUSA: PSUSA/00000342/202407 - periodic safety update report single assessment | New |
| 13/02/2025 | Medicine: Docetaxel Accord | Updated |
| 13/02/2025 | PIP: EMEA-003174-PIP01-21-M01 - paediatric investigation plan | Updated |
| 13/02/2025 | Medicine: Dimethyl fumarate Neuraxpharm | Updated |
| 13/02/2025 | PIP: EMEA-001786-PIP01-15-M03 - paediatric investigation plan | Updated |
| 13/02/2025 | Medicine: Tabrecta | Updated |
| 13/02/2025 | Medicine: Nimenrix | Updated |
| 13/02/2025 | Medicine: Ruxience | Updated |
| 13/02/2025 | Medicine: Ozempic | Updated |
| 13/02/2025 | PIP: EMEA-003507-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003499-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003497-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003469-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003496-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003419-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003396-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-002674-PIP01-19 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-002022-PIP02-23 - paediatric investigation plan | New |
| 13/02/2025 | Event: Training on human variations web-based electronic application form (eAF) functionalities for non-CAPs variations | Updated |
| 13/02/2025 | PIP: EMEA-003071-PIP02-23 - paediatric investigation plan | New |
| 13/02/2025 | Page: Overview of the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Scientific guideline | Updated |
| 13/02/2025 | Page: Overview of the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Scientific guideline | Updated |
| 13/02/2025 | PIP: EMEA-003025-PIP03-23-M01 - paediatric investigation plan | Updated |
| 13/02/2025 | PIP: EMEA-003233-PIP01-22 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-001299-PIP03-17-M03 - paediatric investigation plan | Updated |
| 13/02/2025 | Document: Minutes - PDCO minutes of the 10-13 December 2024 meeting | New |
| 13/02/2025 | PIP: EMEA-003437-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003486-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003490-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003386-PIP01-22 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003421-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-003488-PIP01-23 - paediatric investigation plan | New |
| 13/02/2025 | Medicine: Locametz | Updated |
| 13/02/2025 | PIP: EMEA-002798-PIP04-23 - paediatric investigation plan | New |
| 13/02/2025 | PIP: EMEA-002329-PIP02-20-M03 - paediatric investigation plan | Updated |
| 13/02/2025 | PIP: EMEA-002208-PIP01-17-M03 - paediatric investigation plan | Updated |
| 13/02/2025 | Medicine: Xaluprine (previously Mercaptopurine Nova Laboratories) | Updated |
| 13/02/2025 | Medicine: Lydisilka | Updated |
| 13/02/2025 | Page: ICH M12 on drug interaction studies - Scientific guideline | Updated |
| 13/02/2025 | PIP: EMEA-001911-PIP03-23 - paediatric investigation plan | New |
| 13/02/2025 | Document: Implementation strategy of ICH Guideline M12 on drug interaction studies | New |
| 13/02/2025 | PIP: EMEA-001731-PIP01-14-M04 - paediatric investigation plan | Updated |
| 12/02/2025 | Document: Antimicrobial Sales and Use (ASU) Platform: Release notes | Updated |
| 12/02/2025 | Medicine: Wyost | Updated |
| 12/02/2025 | Medicine: Actelsar HCT | Updated |
| 12/02/2025 | Medicine: Dafiro HCT | Updated |
| 12/02/2025 | Medicine: Copalia HCT | Updated |
| 12/02/2025 | Medicine: Exforge HCT | Updated |
| 12/02/2025 | Medicine: Dafiro | Updated |
| 12/02/2025 | Medicine: Copalia | Updated |
| 12/02/2025 | Medicine: Exforge | Updated |
| 12/02/2025 | Medicine: Skytrofa (previously Lonapegsomatropin Ascendis Pharma) | Updated |
| 12/02/2025 | Page: Budesonide, gastro-resistant hard capsules with prolonged release properties, 3 mg, product-specific bioequivalence guidance | New |
| 12/02/2025 | Page: Budesonide, prolonged release tablets, 9 mg product- specific bioequivalence guidance | New |
| 12/02/2025 | Page: Budesonide, gastro-resistant hard capsules, 3 mg, gastro- resistant granules, 9 mg product-specific bioequivalence guidance | New |
| 12/02/2025 | PIP: EMEA-002862-PIP01-20-M04 - paediatric investigation plan | Updated |
| 12/02/2025 | Page: Product-specific bioequivalence guidance | Updated |
| 12/02/2025 | PIP: EMEA-003360-PIP01-22 - paediatric investigation plan | New |
| 12/02/2025 | PIP: EMEA-003587-PIP01-24 - paediatric investigation plan | New |
| 12/02/2025 | Document: HMPC meeting report on European Union herbal monographs, guidelines and other activities - 20-22 January 2025 | New |
| 12/02/2025 | Medicine: Duloxetine Viatris (previously Duloxetine Mylan) | Updated |
| 12/02/2025 | Medicine: Pemetrexed Fresenius Kabi | Updated |
| 12/02/2025 | Medicine: Emblaveo | Updated |
| 12/02/2025 | Medicine: Pemetrexed Accord | Updated |
| 12/02/2025 | Document: Agenda - European medicines agencies network strategy (EMANS) to 2028 - webinar | Updated |
| 12/02/2025 | Page: Nilotinib product-specific bioequivalence guidance | New |
| 12/02/2025 | Document: Overview of comments received on `Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance’ (EMA/CHMP/518671/2023) | New |
| 12/02/2025 | Document: Nilotinib hard capsules 50, 150 and 200 mg product-specific bioequivalence guidance | New |
| 12/02/2025 | Medicine: Myalepta | Updated |
| 11/02/2025 | PIP: EMEA-000802-PIP01-09 - paediatric investigation plan | Updated |
| 11/02/2025 | Herbal: Boldi folium - herbal medicinal product | Updated |
| 11/02/2025 | Medicine: Karvezide | Updated |
| 11/02/2025 | Medicine: CoAprovel | Updated |
| 11/02/2025 | Medicine: Repaglinide Teva | Updated |
| 11/02/2025 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products | Updated |
| 11/02/2025 | Medicine: Aprovel | Updated |
| 11/02/2025 | Page: Non-clinical Working Party | Updated |
| 11/02/2025 | Medicine: Armisarte (previously Pemetrexed Actavis) | Updated |
| 11/02/2025 | Page: Supporting innovation | Updated |
| 11/02/2025 | Document: Consolidated 3-year work plan for the Emergency Task Force (ETF) | Updated |
| 11/02/2025 | Medicine: Kinpeygo | Updated |
| 11/02/2025 | Medicine: Korjuny | Updated |
| 11/02/2025 | Medicine: Hetronifly | Updated |
| 11/02/2025 | Document: Agenda of the CVMP meeting 11-13 February 2025 | New |
| 11/02/2025 | Document: Jakavi-H-C-002464-X-0070-G : EPAR - Assessment report - Variation | New |
| 10/02/2025 | Document: Applications for new human medicines under evaluation: February 2025 | New |
| 10/02/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 10 - 13 February 2025 | Updated |
| 10/02/2025 | Document: Agenda of the PRAC meeting 10-13 February 2025 | New |
| 10/02/2025 | Medicine: Ituxredi | Updated |
| 10/02/2025 | Document: Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance | Updated |
| 10/02/2025 | Event: Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party | Updated |
| 10/02/2025 | Event: Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024 | Updated |
| 10/02/2025 | Document: Minutes of the PRAC meeting 25-28 November 2024 | New |
| 10/02/2025 | Event: ACT EU multi-stakeholder platform annual meeting | Updated |
| 10/02/2025 | Document: Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA) | Updated |
| 10/02/2025 | Document: Advice to medical device manufacturers - 2025 Timetable | New |
| 10/02/2025 | Document: Request for advice on the clinical development strategy and / or clinical investigations according to Article 61(2) of Regulation (EU) 2017/745 on from the medical device expert panels | New |
| 10/02/2025 | Document: Guide to manufacturers on the procedure for requesting advice from expert panels on clinical investigations and / or clinical development strategies for high-risk medical devices | New |
| 10/02/2025 | Page: Linguistic review - Human | Updated |
| 07/02/2025 | PSUSA: PSUSA/00003148/202405 - periodic safety update report single assessment | New |
| 07/02/2025 | Medicine: Kesimpta | Updated |
| 07/02/2025 | Medicine: Datroway | Updated |
| 07/02/2025 | Page: Industry Standing Group | Updated |
| 07/02/2025 | Medicine: Stivarga | Updated |
| 07/02/2025 | Document: Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 27-30 January 2025 | New |
| 06/02/2025 | Page: Careers | Updated |
| 06/02/2025 | Document: EMA human resources strategy: Priorities 2023-2025 | New |
| 06/02/2025 | Event: Product Management Service (PMS) webinar on Product User Interface (PUI) edit functionalities for industry users | Updated |
| 06/02/2025 | Medicine: Epruvy (previously Ranibizumab Midas) | Updated |
| 06/02/2025 | Page: EudraVigilance training and support | Updated |
| 06/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) - December 2024 | Updated |
| 06/02/2025 | Page: Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Scientific guideline | Updated |
| 06/02/2025 | Medicine: Tolfenamic acid VMD | Updated |
| 06/02/2025 | Medicine: Quviviq | Updated |
| 06/02/2025 | Medicine: Keytruda | Updated |
| 06/02/2025 | PIP: P/87/2010 - paediatric investigation plan | Updated |
| 06/02/2025 | Medicine: Eurneffy | Updated |
| 06/02/2025 | Page: Submission deadlines for orphan designations | Updated |
| 06/02/2025 | Medicine: Jaypirca | Updated |
| 06/02/2025 | Medicine: Tevimbra | Updated |
| 06/02/2025 | Page: Medicine shortages and availability issues | Updated |
| 06/02/2025 | Medicine: Icandra (previously Vildagliptin / metformin hydrochloride Novartis) | Updated |
| 05/02/2025 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) - tracked changes | Updated |
| 05/02/2025 | Document: Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746) | Updated |
| 05/02/2025 | PSUSA: PSUSA/00002229/202404 - periodic safety update report single assessment | New |
| 05/02/2025 | PIP: EMEA-001434-PIP01-13-M03 - paediatric investigation plan | Updated |
| 05/02/2025 | PSUSA: PSUSA/00010774/202403 - periodic safety update report single assessment | New |
| 05/02/2025 | Medicine: Lantus | Updated |
| 05/02/2025 | Medicine: Apidra | Updated |
| 05/02/2025 | Medicine: Vumerity | Updated |
| 05/02/2025 | Page: Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meetings | Updated |
| 05/02/2025 | Medicine: Penbraya | Updated |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – December 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – November 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – October 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – September 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – July 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – June 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025 | New |
| 05/02/2025 | Event: Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – April 2025 | New |
| 05/02/2025 | Event: Questions and answers clinic on post-authorisation procedure management in IRIS - 17 Jan 2025 | Updated |
| 05/02/2025 | Event: Twelfth Industry Standing Group (ISG) meeting | Updated |
| 05/02/2025 | Medicine: Zomarist | Updated |
| 05/02/2025 | Medicine: Xiliarx | Updated |
| 05/02/2025 | Medicine: Emtricitabine/Tenofovir disoproxil Krka d.d. | Updated |
| 05/02/2025 | Medicine: Enyglid | Updated |
| 05/02/2025 | Medicine: Ponvory | Updated |
| 05/02/2025 | Medicine: Ilaris | Updated |
| 05/02/2025 | Medicine: Urorec | Updated |
| 05/02/2025 | Medicine: Nivestim | Updated |
| 05/02/2025 | Medicine: Hukyndra | Updated |
| 05/02/2025 | Medicine: Kisqali | Updated |
| 05/02/2025 | Medicine: Jalra | Updated |
| 05/02/2025 | Medicine: Vabysmo | Updated |
| 05/02/2025 | Shortage: Eldisine | Updated |
| 04/02/2025 | Medicine: Alkindi | Updated |
| 04/02/2025 | Medicine: Rapamune | Updated |
| 04/02/2025 | Medicine: Repaglinide Krka | Updated |
| 04/02/2025 | Event: Questions and answers clinic on post-authorisation procedure management in IRIS | Updated |
| 04/02/2025 | Medicine: Vueway | Updated |
| 04/02/2025 | Medicine: Elucirem | Updated |
| 04/02/2025 | Medicine: Truxima | Updated |
| 04/02/2025 | Medicine: Blitzima | Updated |
| 04/02/2025 | Page: Vaccines Working Party | Updated |
| 04/02/2025 | Page: Methodology Working Party | Updated |
| 04/02/2025 | Page: 3Rs Working Party | Updated |
| 04/02/2025 | Page: Quality Working Party | Updated |
| 04/02/2025 | Page: Rheumatology/Immunology Working Party | Updated |
| 04/02/2025 | Page: Haematology Working Party | Updated |
| 04/02/2025 | Medicine: Hepcludex | Updated |
| 04/02/2025 | Page: Biologics Working Party | Updated |
| 04/02/2025 | Page: Biosimilar Medicinal Products Working Party | Updated |
| 04/02/2025 | Page: Central Nervous System Working Party | Updated |
| 04/02/2025 | Page: Cardiovascular Working Party | Updated |
| 04/02/2025 | Medicine: Zolgensma | Updated |
| 04/02/2025 | Medicine: Izelvay | Updated |
| 03/02/2025 | Page: Availability of medicines before and during crises | Updated |
| 03/02/2025 | PSUSA: PSUSA/00000408/202405 - periodic safety update report single assessment | New |
| 03/02/2025 | Page: Qualification of non-mutagenic impurities - Scientific guideline | Updated |
| 03/02/2025 | Document: Nanotechnology-based medicinal products for human use EU-IN Horizon Scanning Report | New |
| 03/02/2025 | Medicine: Obizur | Updated |
| 03/02/2025 | Medicine: Trazimera | Updated |
| 03/02/2025 | Document: Committee for Advanced Therapies (CAT): Work Plan 2025 | New |
| 03/02/2025 | Medicine: Fortacin | Updated |
| 03/02/2025 | Medicine: Gohibic | Updated |
| 03/02/2025 | Medicine: Eucreas | Updated |