The initiative aims to strengthen clinical trials safety monitoring in the European Union (EU).
This is achieved by maintaining a clinical trials pharmacovigilance network, including regular dialogue of safety assessors and collaboration between clinical trial and post-marketing pharmacovigilance.
In this context, Member States work together to improve trial safety through coordinated work-sharing assessment, facilitated by the EU4Health Joint Action 12 (SAFE CT), which is focused on capacity building and training.
ACT EU has also developed a training curriculum for safety assessors.
Final conference of SAFE CT
The SAFE CT Final Conference, organised by the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) on behalf of the SAFE CT consortium, was held in Zagreb on 19 March 2026.
The final conference brought together around 70 representatives from 25 national competent regulatory authorities from the member states of the European Union and the European Economic Area and provided an opportunity to present the project’s key results and exchange experience gained during its implementation.
At the opening of the conference, participants were welcomed by the Head of HALMED. Keynote speakers for the conference were the Chair of the Clinical Trials Coordination Group (CTCG) within the Heads of Medicines Agencies (HMA) and a stakeholder representative.
Activities of all work packages implemented throughout the project were presented, including capacity building, sustainability, evaluation (analysis of the achievement of the project activities and deliverables), dissemination (communication of the SAFE CT activities during the project), and coordination. Particular emphasis was placed on the experience of new assessors employed within the SAFE CT project, as well as on the experience of their mentors.
The final conference provided a valuable opportunity to reflect on the achievements of the SAFE CT project, highlight the strengthened collaboration among European regulatory authorities, and outline key considerations for ensuring the sustainability of harmonised safety assessment in clinical trial assessment across the EU/EEA.
The event marked the successful upcoming conclusion of the project.
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 (24 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.
