Clinical Trial Regulation (CTR)

The Clinical Trial Regulation (EU) No 536/2014 [CTR] is an European Union framework designed to harmonize and streamline the approval and conduct of clinical trials across EU/EEA Member States. It aims to enhance the safety of participants, increase transparency, and improve the efficiency of clinical research within the EU/EEA.

The CTR, which became applicable on January 31, 2022, replaces the earlier Clinical Trials Directive (2001/20/EC). It introduces a centralized system through the Clinical Trials Information System (CTIS), where sponsors can submit a single application for authorization of a clinical trial conducted in multiple EU/EEA countries.

The EU Commission conveys that key features include a harmonized application process, coordinated timelines for assessment, and enhanced public access to clinical trial data, fostering transparency and trust in medical research.