Transitioned trials
- Published: January 28, 2022
- Last updated: March 3, 2025
From 31 January 2025 all clinical trials previously regulated by Directive 2001/20/EC must have been transitioned to CTR in order to continue to be conducted.
Only clinical trials previously authorised according to Directive 2001/20/EG with at least one active site after 30 January 2025 must have been transitioned by an application in CTIS. Active site in the context of transition trials means that the last visit of the last subject, or other trial-specific interventions with the subject specified in the protocol take place after 30 January 2025.
At the time of the first substantial modification after transition, the sponsor must submit documents updated according to CTR. Please refer to ”Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation” on the EU Commission webpage and documents on HMA webpage under section Clinical Trial Coordination Group/Key document list/Transitional trials.
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