Clinical Trials Information System (CTIS) Highlights

On 6 August 2021 the EMA published the issue 4 of the CTIS highlights newsletter from August 2021.

On the 31st of July 2021, a major CTIS milestone has been reached. The coming into application of the Clinical Trials Regulation (EU) No 536/2014 and therefore the go-live date for CTIS has now been confirmed as 31 January 2022, meaning the six-month countdown to CTIS has begun. The European Commission has established this through their notice published in the Official Journal of the European Union.

When CTIS goes live, it will harmonise the submission, assessment and supervision of clinical trials in the EU and the EEA.

CTIS will streamline submission processes for commercial, non-commercial and academic clinical trial sponsors. In addition, it will streamline the authorisation and supervision process for the EU/EEA Member States. The European Commission will play a role in the supervision of the implementation of the Regulation.

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