Francesca Spera -


Clinical trials authorized under Directive 2001/20/EC (CTD) that are still ongoing after January 30th, 2025 will have to migrate to Regulation (EU) no. 536/2014 (CTR) by that date, upon submission and authorization of a “transitioning application” in the Clinical Trials Information System (CTIS).


Clinical trials that have not been resubmitted in CTIS will have to be stopped and those who are still unauthorized in CTIS will have to be suspended until the transition is completed.


Therefore, AIFA strongly recommends submitting transition applications in advance, considering the time necessary for validation/evaluation, which can extend from 1 week up to 106 days. Thus, Sponsor should consider October 16th, 2024 as the final date by which to submit the application in order to guarantee the finalization of the procedural outcome by January 30th, 2025.


RPN will provide any further update and is available to provide full support for transition applications in CTIS.




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