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Submission study before 31 January 2023

CTIS was launched on 31 January 2022, starting the clock for the one-year transition time for all sponsors of clinical trials. During the first year of the transition period, clinical trial sponsors can choose whether to submit an initial clinical trial application in line with the Clinical Trials Directive 2001/20/EG or under the Clinical Trials Regulation (CTR), via CTIS.

The last date for sponsors to submit initial Clinical Trial Applications under the Clinical Trials Directive is 30 January 2023. Starting from 31 January 2023, the use of CTIS will be mandatory for all initial clinical trial application in the EU.

We would like to underline that the submission to the EC’s and the FAMHP until 30/1/2023 (23:59) is sufficient to still fall under the Clinical Trials Directive regime. In other words: a study does not have to be validated on 30/1/2023. A submission before 31 January 2023 is sufficient to still evaluate the study under the Clinical Trials Directive, and not under the CTR.

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