14/05/2024 | Document: Agenda of the PRAC meeting 13-16 May 2024 | Updated |
14/05/2024 | Document: Guidebook for tenderers | Updated |
14/05/2024 | Document: Article 57 product data | Updated |
14/05/2024 | Medicine: Thalidomide Lipomed | Updated |
14/05/2024 | Medicine: Mayzent | Updated |
14/05/2024 | Page: Clinical Trials Information System: training and support | Updated |
14/05/2024 | Event: Clinical Trials Information System (CTIS): Walk-in clinic - July 2024 | Updated |
14/05/2024 | Medicine: Olanzapine Mylan | Updated |
14/05/2024 | Event: Information and Q&A session on updated CAPs in web-based eAF | Updated |
14/05/2024 | Document: Minutes of the PRAC meeting 4-7 March 2024 | New |
14/05/2024 | Medicine: Vegzelma | Updated |
14/05/2024 | Medicine: Poteligeo | Updated |
14/05/2024 | Document: Products Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe - Chapter 1 | Updated |
14/05/2024 | Medicine: Aspaveli | Updated |
14/05/2024 | Document: On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services | Updated |
14/05/2024 | Document: Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe: Introduction - EU Implementation Guide | Updated |
14/05/2024 | Event: EMA/FVE info session on restrictions for the use of certain antimicrobials in animals | Updated |
13/05/2024 | Medicine: Flixabi | Updated |
13/05/2024 | Medicine: GONAL-f | Updated |
13/05/2024 | Medicine: Agamree | Updated |
13/05/2024 | Medicine: Ryzneuta | Updated |
13/05/2024 | Medicine: Axumin | Updated |
13/05/2024 | Medicine: Bexsero | Updated |
13/05/2024 | Medicine: GHRYVELIN (previously Macimorelin Aeterna Zentaris) | Updated |
13/05/2024 | Medicine: Scenesse | Updated |
13/05/2024 | Medicine: Anagrelide Viatris (previously Anagrelide Mylan) | Updated |
13/05/2024 | Medicine: Myozyme | Updated |
13/05/2024 | Medicine: Zepatier | Updated |
13/05/2024 | Medicine: Fabrazyme | Updated |
13/05/2024 | Medicine: Kauliv | Updated |
13/05/2024 | Medicine: Onglyza | Updated |
13/05/2024 | Medicine: Fingolimod Accord | Updated |
13/05/2024 | Medicine: Rasagiline Mylan | Updated |
13/05/2024 | Medicine: Plerixafor Accord | Updated |
13/05/2024 | Medicine: Pregabalin Mylan | Updated |
13/05/2024 | Medicine: Atriance | Updated |
13/05/2024 | Medicine: Spinraza | Updated |
13/05/2024 | Medicine: Darunavir Mylan | Updated |
13/05/2024 | Medicine: Granupas (previously Para-aminosalicylic acid Lucane) | Updated |
13/05/2024 | Medicine: Vyndaqel | Updated |
13/05/2024 | Medicine: Dupixent | Updated |
13/05/2024 | Medicine: Telmisartan Actavis | Updated |
13/05/2024 | Medicine: Luxturna | Updated |
13/05/2024 | Medicine: Leqvio | Updated |
13/05/2024 | Medicine: Heplisav B | Updated |
13/05/2024 | Medicine: Orkambi | Updated |
13/05/2024 | Medicine: Reblozyl | Updated |
13/05/2024 | Medicine: Abrysvo | Updated |
13/05/2024 | Medicine: Keytruda | Updated |
13/05/2024 | Medicine: Tresiba | Updated |
13/05/2024 | Medicine: Isentress | Updated |
13/05/2024 | Medicine: Ryzodeg | Updated |
08/05/2024 | Page: CVMP recommendations on limited market classification and eligibility for authorisation under Article 23 | Updated |
08/05/2024 | Document: Timetable: Post-authorisation safety study (PASS) protocols and final results | Updated |
08/05/2024 | Page: Website outages and upgrades | Updated |
08/05/2024 | Document: Timetable: Initial (Full) marketing authorisation application - ATMP | Updated |
07/05/2024 | Document: Organisation chart: Advisory functions | Updated |
07/05/2024 | Page: Need for maximum residue limit (MRL) evaluation for biological substances - Scientific guideline | Updated |
07/05/2024 | Medicine: Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | Updated |
07/05/2024 | Herbal: Hippocastani cortex - herbal medicinal product | Updated |
07/05/2024 | News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024 | Updated |
07/05/2024 | News: EMA closed 9-10 May | New |
07/05/2024 | Event: Information session on Call for Proposals "EU 4 AMA: leveraging European expertise for medicines regulation in Africa" | New |
07/05/2024 | Page: PRIME: priority medicines | Updated |
07/05/2024 | Document: List of medicines currently in PRIME scheme | Updated |
07/05/2024 | Medicine: Emblaveo | Updated |
07/05/2024 | News: One Health: a joint framework for action published by five EU agencies | New |
07/05/2024 | Event: Product Management Service (PMS) Info-Day | Updated |
07/05/2024 | Page: COVID-19 vaccines: key facts | Updated |
06/05/2024 | Document: Record of data processing activity relating to Security Access Control System (public) | Updated |
06/05/2024 | Document: Records of data processing activity (public) for audiovisual tool for checking presence in meeting rooms | New |
06/05/2024 | Document: European Medicines Agency’s privacy statement for the operation of the Security Access Control System | Updated |
06/05/2024 | Document: European Medicines Agency’s data protection notice for the audiovisual tool for checking presence in meeting rooms | New |
06/05/2024 | Page: Procurement | Updated |
06/05/2024 | Event: EMA and EORTC multi-stakeholder workshop on soft tissue and bone sarcoma | Updated |
06/05/2024 | PSUSA: PSUSA/00002310/202308 - periodic safety update report single assessment | New |
06/05/2024 | Document: Meeting report - Joint EMA/EORTC Workshop on Soft Tissue and Bone Sarcoma Workshop | New |
06/05/2024 | Document: Minutes of the COMP meeting 12-14 March 2024 | New |
06/05/2024 | Referral: Synapse - referral | Updated |
06/05/2024 | Medicine: Adynovi | Updated |
06/05/2024 | Medicine: Advate | Updated |
06/05/2024 | Document: Clinical Trial Information System (CTIS) structured data form - Initial application, additional Member State Concerned, substantial modification, non-substantial modification | Updated |
06/05/2024 | Document: List of signals discussed at PRAC since September 2012 | Updated |
06/05/2024 | Document: PRAC recommendations on signals adopted at the 8-11 April 2024 PRAC meeting | New |
03/05/2024 | Medicine: MenQuadfi | Updated |
03/05/2024 | PIP: EMEA-002754-PIP01-19 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-002693-PIP01-19 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-003157-PIP01-21 - paediatric investigation plan | Updated |
03/05/2024 | PIP: EMEA-001666-PIP01-14-M01 - paediatric investigation plan | Updated |
03/05/2024 | Document: Agenda - Joint HMA/EMA Big Data Steering Group Workshop on RWE methods | Updated |
03/05/2024 | Document: Agenda - Twelfth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines | Updated |
03/05/2024 | Event: Third European Medicines Agency and Affordable Medicines Europe bilateral meeting | Updated |
03/05/2024 | PSUSA: PSUSA/00002589/202307 - periodic safety update report single assessment | New |
03/05/2024 | Medicine: Briumvi | Updated |
03/05/2024 | Document: Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23 | Updated |
03/05/2024 | Medicine: Tevimbra | Updated |
03/05/2024 | Event: Q&A Clinic for IRIS Network users for transitioned regulatory procedures | New |
03/05/2024 | Medicine: Sivextro | Updated |
03/05/2024 | Medicine: Talzenna | Updated |
03/05/2024 | Page: ICH M10 on bioanalytical method validation - Scientific guideline | Updated |
03/05/2024 | Page: Plasma master file certificates | Updated |
03/05/2024 | Page: Big data | Updated |
03/05/2024 | Page: Real-world evidence | New |
03/05/2024 | Page: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence - Scientific guideline | New |
03/05/2024 | Document: Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence | New |
02/05/2024 | Document: Template for scientific document (part B-F) | Updated |
02/05/2024 | Event: CVMP Interested Parties’ meeting | New |
02/05/2024 | Document: Scientific recommendations on classification of advanced therapy medicinal products | Updated |
02/05/2024 | Document: Appendix 1: Acceptable intakes established for N-nitrosamines | Updated |
02/05/2024 | Page: Information Management | Updated |
02/05/2024 | Herbal: Malvae sylvestris flos - herbal medicinal product | Updated |
02/05/2024 | Medicine: Pelmeg | Updated |
02/05/2024 | Medicine: Noxafil | Updated |
02/05/2024 | Medicine: Teriflunomide Accord | Updated |
02/05/2024 | Medicine: Byooviz | Updated |
02/05/2024 | Medicine: Pluvicto | Updated |
02/05/2024 | Medicine: RotaTeq | Updated |
02/05/2024 | Medicine: Tracleer | Updated |
02/05/2024 | Medicine: Stayveer | Updated |
02/05/2024 | Document: Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure | New |
02/05/2024 | Event: EU NTC ten year anniversary event | New |
02/05/2024 | Medicine: Volibris | Updated |
02/05/2024 | Herbal: Malvae folium - herbal medicinal product | Updated |
02/05/2024 | Medicine: Vafseo | Updated |
02/05/2024 | Medicine: Incellipan | Updated |
02/05/2024 | Page: Handling competing interests | Updated |
02/05/2024 | Medicine: Celldemic | Updated |
02/05/2024 | Medicine: Zynyz | Updated |
02/05/2024 | Document: CAT quarterly highlights and approved ATMPs - February - April 2024 | New |
02/05/2024 | Page: Quality of medicines questions and answers: Part 1 | Updated |
02/05/2024 | Page: Stability testing for applications for variations to a marketing authorisation for veterinary medicinal products - Scientific guideline | Updated |
02/05/2024 | Document: Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products | New |
02/05/2024 | Medicine: Mirapexin | Updated |
02/05/2024 | Document: Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling | New |
02/05/2024 | Document: List of eligible industry stakeholder organisations | Updated |