We are now only 7 months away from the end of the 3-year transition period to the Clinical Trials Regulation (CTR). Sponsors are reminded to transition any trials that are expected to continue after 30 January 2025 from the Clinical Trials Directive to the CTR.

Sponsors should take into account the time necessary for completion of the Member State(s) evaluation procedure, which can take up to 3 months. Members States have agreed on an expedited procedure for transitioning trials to the CTR which will be applied whenever possible, as described in the CTCG Best practice guide.

Clinical trials that have not transitioned to the CTR by 30 January 2025 will be considered non-compliant with the CTR, as highlighted in the European Commission’s guidance on transition.

Further resources to support sponsors transitioning trials are available on the CTIS website.

-       EMA Clinical Trials Team