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Transition of clinical trials to the Clinical Trials Regulation

Published 28 December 2023 by Nuno Almeida Ribeironuno almeida ribeiro Coelho Ribeiro & Associados, Portugal

The Clinical Trials Regulation (CTR), effective from January 31, 2022, introduced a pivotal change in the EU’s clinical trial landscape. Transitioning from the previous Clinical Trial Directive (CTD) to the CTR involves submitting a streamlined “transitioning application” before January 30, 2025. This regulatory evolution underscores efficiency and transparency in clinical trials, urging sponsors to initiate the transition process promptly for uninterrupted trial continuity under the CTR.

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