Submission of an application for transition of a clinical trial

Transition applications concern clinical trials (and combination trials) that have already been approved by an ethics committee and authorized by an NCA under the CTD. An application for transition of a clinical trial is submitted to CTIS.

A transition application must be submitted if the study continues after the 30th of January 2025. If the trial ends before this date in the EU/EEA (more specifically in all MSs within the EU/EEA), there is no need for a transition application

No fee is charged for processing transition applications.

More detailed guidance on transition applications can be found in Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials RegulationSee also  EudraLex volume 10 document, which is updated regularly.

EU-portaali ja -tietokanta

Euroopan komission transitio-ohje

EudraLex - Volume 10 - Clinical trials guidelines

Frequently asked questions about transition trials