The initiative aims to successfully establish clinical trials safety monitoring in the European Union (EU).
This would see EU Member States working together to improve trial safety through coordinated work-sharing assessment, facilitated by the EU4Health Joint Action 12.
To support these activities, ACT EU is focused on training for safety assessors, with the development of a curriculum to harmonise expertise.
ACT EU will also enable the implementation of the ICH E19 guideline on selective safety data collection.
SAFE CT
Safe-CT Project Extension
The Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) Steering Committee are delighted to announce the extension of the project for 1 year, from April 2025 to April 2026. The amendment to extend the project duration was approved by the European Commission on (24th April 2025). The project will continue to support the objectives of Joint Action (JA)12 in fostering cooperation and harmonisation of safety assessment for clinical trials within the European Union.
The Clinical Trial Regulation and Implementing regulation which became applicable on 31 January 2022 introduced the concept of safety cooperation and work-sharing among Member States.
Joint Action (JA) 12 of the EU4Health Safety Assessment Cooperation and Facilitated Conduct of Clinical Trials (SAFE CT) supports these new concepts through provision of additional resources and expertise necessary to implement the new regulation.
The goal of this JA is to establish and maintain cooperation in safety data assessment in clinical trials via building capacities and performing training activities in the participating Member States. The experience gained during the JA will be used to update and improve the procedures on cooperation and training in safety surveillance in clinical trials.
More information is available under the Joint Actions section of the webpage: Heads of Medicines Agencies: Clinical Trials Coordination Group.
