Clinical Trials Regulation now fully applicable in EU

31 January 2025

As of today, all clinical trials in the European Union (EU), including those that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR).

This marks the end of a three-year transition period, during which more than 5,000 studies were transitioned to the CTR through submission to the Clinical Trials Information System (CTIS), the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU.

Remaining trials that are ongoing after January 30 and that were not moved to the new system may be subject to corrective measures applied by EU member states.

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