Medicinal products - Latest updates

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 pharmaceutical legislation

Questions and Answers on the Recommendation on Antimicrobial Resistance

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

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

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

Recommendation paper on decentralised elements in clinical trials

Pharmaceuticals: Commission proposes updated EMA fees

Biosimilar medicines - Multistakeholder Event (13 December 2022)

Staff Working Document on Vulnerabilities of the global supply chains of medicines – Structured Dialogue on the security of medicines supply

Agenda - 100th meeting of the Pharmaceutical Committee (21 October 2022)

Civil Society representatives: Call for expressions of interest for the EMA PDCO Committee