Since January 31, 2023, all new applications for research involving medicinal products have been submitted via the new Clinical Trials Information System (CTIS). All ongoing studies approved under the CTD must be transferred to CTIS by January 30, 2025 at the latest. These so-called transition trials should be registered in CTIS and should be approved by all Member States concerned (MSC) before the end of the transition period (31 January 2025). An expedited administrative procedure is foreseen up to 16 October 2024. This procedure can take up to 22 days if there are no request for information (RFI), or up to 37 days for research files with validation questions. In principle, a study in transition is not reassessed. In exceptional cases, a question period (RFI) may take place during the assessment phase. In that case, the expedited administrative procedure expires and the standard CTR periods apply (maximum 106 days). During the transition, the study may continue under the CTD.
More information can be found on this website of the CCMO.