Navigating the process complexities and challenges associated with EU-CTR transition applications

By Shivam Vashisth and Marion Schoeffel2024-05-08T09:30:00

Abstract

From 31 January 2025, clinical trials authorised under the old EU Clinical Trial Directive (CTD) must either have ended in the EU/EEA or have been transitioned to new EU Clinical Trial Regulation (CTR). Therefore, any ongoing trial with at least one active site in the EU beyond 30 January 2025 needs to be transitioned to the CTR before expiry of the transition period. The EU Clinical Trial Coordination Group (CTCG) has agreed on an expedited, harmonised member state (MS) evaluation procedure based on the validation of minimum application dossiers restricted to documents already authorised under the EU CTD.

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