Registration and agenda - Biosimilar medicines - Multistakeholder Event (13 December 2023)

Agenda - 101st meeting of the Pharmaceutical Committee (23 November 2023)

First electronic product information (ePIs) published for selected human medicines

Open Calls for expressions of interest - EMA COMP and EMA PRAC Committees

Updated document - ICH Q9 Quality Risk Management

Updated document - Questions & Answers : Clinical Trials Regulation (EU) No 536/2014

Guidance for the transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

Phasing out of extraordinary COVID-19 regulatory flexibilities

Agenda - Stakeholder workshop on the “Transparency Directive” (Directive 89/105/EEC) (29 June 2023)

EU-US agreement on GMP inspections brings high quality medicines faster to animals

European Health Union: Commission proposes pharmaceuticals reform for
more accessible, affordable and innovative medicines

Questions and Answers on the Recommendation on Antimicrobial Resistance

Questions and Answers on the pharmaceutical legislation

Presentations and video recordings - Multistakeholder Event on Biosimilar medicines (13 December 2022)

Quick guide for sponsors - Regulation 536/2014 in practice (Eudralex vol. 10)

Improving the quality of medicines

Clinical Trials: EU survey on the implementation of the Clinical Trial Regulation

Agenda and Pre-registration - Webinar on Best practices in the public procurement of medicines (7 February 2023, 10:00-12:30 CET)

EU Guideline on orphan applications (for designation and transfer) - 2022/C 440/02