New Clinical Trials Regulation published
Recommendation
4-6 March 2025
Management, Supply and Quality Assurance of Clinical Trials
Register now for ECA's GMP Newsletter
The new Clinical Trials Regulation with the official title "Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC" has been published in the Official Journal of the EU.
Besides the goal to simplify clinical trial approvals, the Regulation aims to foster transparency on the conduct of trials in the European Economic Area (EEA). This will be achieved now by providing the legal basis for the publication of clinical trial results. The respective IT-tools and platforms will be implemented by the European Medicines Agency (EMA) to "support sponsors and experts in the Member States in carrying out their roles in relation to the authorisation of trials, their supervision, safety reporting and compliance activities, as well as to enable public access to information on clinical trials".
Source: EMA press release
Related GMP News
18.12.2024Swissmedic Position Paper on Clinical Trials
05.12.2024ICH E6(R3) Annex 2 Draft Guideline Released
05.12.2024ICH M15 Draft Guideline on Model-Informed Drug Development
07.11.2024Interim-Report on EMA's Clinical Study Data Proof-of-Concept Pilot
07.11.2024FDA Issues Guidances to Support Clinical Trial Innovation
17.10.2024FDA's final Q&A Document on Electronic Systems & Data in Clinical Trials