All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 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.
Sponsors of clinical trials expected to continue after 30 January 2025 must consider the time required for Member States to complete the authorisation 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…
