We are now in the final year of transition from the Clinical Trials Directive to the Clinical Trials Regulation (CTR). The application of the CTR strengthens Europe as an attractive location for clinical research by streamlining the processes for application, supervision of clinical trials and the publication of clinical trial data in the Clinical Trials Information System (CTIS).  

All ongoing clinical trials in the EU must be transitioned to CTIS by 30 January 2025. Sponsors with clinical trials expected to continue beyond that date 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, as described in the CTCG Best practice guide.

There is also guidance and additional support materials available to help sponsors make the transition. Sponsors can also attend dedicated training and info events, including the CTIS bitesize talk on 29 February 2024 and a CTIS Info day on 25 March 2024.

- The EMA Clinical Trials Team