Call to action: Start now on the transition of clinical trials to CTR!

Information on ‘transition trials’ is available on the CCMO website: clinical trials that need to be transitioned to the Clinical Trials Regulation. It is estimated that many trials still await transition.

On 31 January 2022 the Clinical Trials Regulation (CTR) came into force with a transition period of three years. All clinical trials authorised under the Clinical Trials Directive (CTD) still ongoing after 30 January 2025 should be transitioned to CTR in time.

The sponsor is responsible for a timely transition to CTR. An expedited administrative procedure is foreseen up to 16 October 2024. For submission beyond this date, a prompt approval cannot be guaranteed.

Information on

On the CCMO website, you may find information for sponsors on ‘transition trials’ answering the following three questions:

  • When should the sponsor transition a clinical trial to CTR?
  • How should a clinical trial be transitioned to CTR?
  • What to do after the clinical trial has been transitioned?

Many clinical trials still await transition. So: do not wait until the last moment to start the transition. Start straightaway!