All applications for authorisations to run a clinical trial must as of 31 January 2023 be submitted via the EU Clinical Trials Information System (CTIS)

On 31 January 2023, it became compulsory to submit applications for new clinical trials through the CTIS EU portal, and this means that the 2022 Clinical Trials Regulation is now fully implemented.

The Clinical Trials Information System has been in partial use since the new Clinical Trials Regulation entered into force on 31 January 2022. For a transition period, it has been possible to submit applications to the local authorities, like under the former directive, as well as through CTIS. The European Medicines Agency (EMA) has continuously been assessing the CTIS functionality throughout the transition period and has been making improvements to the system.

As of 31 January 2023, the system was ready to be fully implemented, and it is now the only access to submitting new applications for clinical trials.

CTIS is advantageous since all applications will be processed through one joint European system. This means that all information on clinical trials being conducted in the EU is gathered in one place, which will make it easier to share trial data across borders.

Changes to ongoing clinical trials can still be submitted as before until 31 January 2025, after which point only CTIS can be used.

A new Q&A on the protection of (i) commercially confidential information and (i) personal data when using CTIS has also just been published. The European Commission and EMA and Heads of Medicines Agencies (HMA) have prepared the Q&A document jointly. Read the Q&A.

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