Medicinal products - Latest updates

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

Update - EudraLex - Volume 10 - Clinical trials guidelines - Questions and Answers Document - Regulation (EU) 536/2014 – Version 6.2 (September 2022)

Revision - Manufacture of Sterile Medicinal Products

Summary record - 99th meeting of the Pharmaceutical Committee (11 May 2022)

Questions and answers - Complex clinical trials

Questions and Answers Document – Regulation (EU) 536/2014 – Version 6.1, May 2022

Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746