Book by 30 June 2026 and get a 10% early-bird discount on all events starting on or after 25 August 2026. To the promotion
GMP search engine – look up GMP compliance regulations and news
New Clinical Trials Regulation published
Recommendation
16-18 June 2026
Management, Supply and Quality Assurance of Clinical Trials
On the Road to 30,000 Members
Let us become the World's Leading GMP/GDP Compliance Community in 2026
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
03.06.2026In-use Storage Time of Reconstituted Medicines
28.05.2026New EMA Q&A on the Implementation of 3DP Technology
28.05.2026EMA publishes Presentations on Contractual Agreements in Clinical Trials
28.05.2026UK Substantial Modifications Pilot
07.05.2026What are the GMP Requirements for Investigational Medicinal Products (IMPs)?