CTR Implementation

Clinical Trials Regulation Implementation

Initiative leader: European Medicines Agency (EMA)

Duration: June 2023 - Not determined


The implementation of the Clinical Trials Regulation is part of the Accelerating Clinical Trials in Europe (ACT EU) initiative, which aims to support the successful and timely implementation of the Clinical Trials Regulation (CTR) and its implementing acts. In this Initiative we find a group of stakeholder representatives that provide feedback on the implementation of the CTIS, including the following tasks and activities:

By 30 January 2025, any ongoing trials under the Clinical Trials Directive will need to be transitioned to CTIS to comply with the Clinical Trials Regulation. By the end of January sponsors have submitted around 690 transitional trials in CTIS out of an estimated 5,000 trials due to be transitioned. To help the sponsors transitioning trials, a guidance paper has been made available by the European Commission, EMA and Clinical Trials Coordination Group (CTCG). Also, a workshop was organised to support the transitions, and there is ongoing support to sponsors as the end of the transition period approaches.

Within the Initiative there are multiple activities in progress for non-commercial sponsors. Among others there is a mapping conducted for existing initiatives at national and European level. Also, there is an optimisation of the regulatory help desk, leveraging on national support. Furthermore, there is an extensive CTR/CTIS support for large multinational clinical trials, there is scientific advice for large multinational clinical trials, a numerous involvement of academia in the Multi Stakeholder Platform Advisory Group. All activities are supported by a communication campaign, workshops and trainings.


ECRIN's Role in CTR Implementation

The Initiative consists of representatives from key stakeholder groups, including patients/consumers, industry EU trades, healthcare professional, academia and networks, and research funders. ECRIN is a permanent representative for academia, representing the priorities for investigator led (multinational) clinical studies.