31 January 2025
EMA: Clinical trials regulation now fully applicable in the European Union
All clinical trials in the European Union (EU), including those previously approved under the Clinical Trials Directive (CTD), are now governed by the Clinical Trials Regulations (CTR). This concludes a three-year transition period, during more than 5,000 trials have been transferred to the Clinical Trials Information System (CTIS), the central platform for trial submission, assessment, and oversight.
The CTIS enhances transparency through a publicly accessible database, while the oversight of clinical trials remains with the EU/EEA Member States, and the European Medicines Agency (EMA) maintains the CTIS. The European Commission oversees the CTR implementation, with further improvements to the CTIS planned throughout 2025.
For more information, see here.
More News
-
-
Swissmedic: New strategic Approach to minimizing Animal Testing in the Development of Medicinal Products
-
European Medicines Agency: New oral GLP-1 Medicine for Weight Management and Type 2 Diabetes
-
Swissmedic: The new Pharmacopoea Helvetica 13
-
FOPH: Capital Income of Health Insurers for Premium Reduction – current voluntary System deemed sufficient
-
Swissmedic: Haemovigilance Annual Report 2025
-
Decision C-6534/2024 of 13 October 2026
-
Swissmedic: GMP Compliance by foreign Manufacturers - Simplifications for Industry and Clarification of unresolved Issues
-
European Medicines Agency: Clinical Trial Applications Advice Pilot becomes permanent
-
European Medicines Agency: Highlights of the September 2026 Management Board meeting