Abstract

All clinical trials authorised under the Clinical Trials Directive (CTD) with at least one active site in the European Economic Area (EEA) on 30 January 2025 must complete the transition to the Clinical Trials Regulation (EU) 536/2014 (CTR)^[1] within the CTR transition period of three years ending on 31 January 2025.^[2] According to the European Medicines Agency (EMA) guidelines,^[3] sponsors needed to submit all relevant CTR transition documents by 16 October 2024 to secure approval by 30 January 2025.^[4] This ensures the complete trial transition and the lawful conduct of the clinical trial, avoiding corrective measures and penalties by member states, and further liability in accordance with CTR Articles 77 and 94 respectively.

As the European Commission (EC) noted when announcing - the launch of a study of CTR implementation, the CTR is ‘yet to realise its full potential in terms of harmonising and facilitating the conduct of clinical trials in the EU’.^[5] It has stated that, by the end of 2024, it will launch a study on the implementation of the CTR to assess its impact on European clinical research and to prepare the required report on the CTR’s functioning.

This article outlines the experiences of Roche in switching a portfolio of approximately 150 ongoing studies within the CTR transition period and its insights into successfully navigating this complex and lengthy process. It reflects on the implementation of CTR, the insights generated from navigating this phase and how the regulation can be a catalyst for Europe’s attractiveness for research and development in an increasingly competitive global environment.

To read the full article, log in as a member or register for free using the links below.