Clinical trials' transition to new EU system - one year left

31 January 2024

All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by January 31, 2025.

This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU, the European Medicines Agency (EMA) advised today.

Sponsors of clinical trials expected to continue after January 30, 2025 must consider the time required for EU member states to complete the authorization procedure, which can take up to three months. To help streamline the process, member states will implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive (CTD), to the Clinical Trials Regulation.

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