End of the Transition Period for Clinical Trials

From 31 January 2025, all clinical trials in the European Union (EU), including ongoing trials authorised under the previous regulatory framework, the Clinical Trials Directive (CTD), will be subject to the Clinical Trials Regulation (CTR). This marks the end of a three-year transition period during which clinical trials were converted to the CTR by submitting them to the Clinical Trials Information System (CTIS), the single point of contact for sponsors and national competent authorities for the submission and assessment of clinical trial applications in the EU.

Clinical trial transfers no longer possible

Only the EMA's CTIS system is now mandatory as the portal for the submission and maintenance of clinical trials in Europe for all clinical trial procedures. During the transition period, ongoing CTD clinical trials had to be adapted to the current regulatory framework of the Clinical Trials Regulation (CTR). Corrective actions may be taken for all trials that have not yet been switched, as clinical trials can not be adapted retrospectively. Transfer applications are no longer possible and sponsors of ongoing CTD trials must submit a new application via the CTIS.  Further information is available on the respective EMA website.