EMA Clinical Trials Highlights

21 December 2022 – the EMA published Issue 12 of the Clinical Trials Highlights newsletter.

Since the launch of CTIS on 31 January 2022, almost 200 clinical trial applications have been authorized and over 200 are under evaluation. During this time, EMA has collaborated with Sponsor and Member State users to identify and successfully resolve technical issues, providing proactive hands-on support to the CTIS user community and strengthening the system ahead of its compulsory use.

As of 31 January 2023, sponsors must submit all initial clinical trial applications under the CTR using CTIS and can no longer submit via the processes outlined in the Clinical Trials Directive.

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