Six-month Countdown to Go-live for the Clinical Trials Information System (CTIS)

On 2 August 2021 the EMA announced six-month countdown to go-live for the CTIS.

The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for the Clinical Trials Information System (CTIS) will be on 31 January 2022.

As set out in the Clinical Trials Regulation, the entry into application of that Regulation is set by the publication of a notice in the Official Journal of the European Union, which confirms that the clinical trial EU Portal and Database, one of the main deliverables of the Regulation and the key component of CTIS, has reached full functionality. The application of the Regulation and the go-live of CTIS take place six months after the publication of this notice.

The Clinical Trials Regulation aims to harmonise the submission, assessment and supervision processes for clinical trials throughout the EU. CTIS will allow the streamlining of these processes, ensuring the EU remains an attractive region for clinical research.

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