The ACT EU workplan for 2023-2026 is now available.
The workplan reflects the updated priorities for the initiative:
- The implementation of the Clinical Trials Regulation (CTR), including support for the transition of clinical trials to the CTR and the CTR Collaborate project, which aims to optimise collaboration between national health authorities and national ethics bodies.
- The creation of a regulatory helpdesk for non-commercial sponsors conducting multi-national clinical trials.
- The creation of the Multi-Stakeholder Platform (MSP) Advisory Group of stakeholder representatives.
- A scientific advice pilot to provide consolidated advice for clinical trial and marketing authorisation applications.
- Regulatory support to clinical trials in public health emergencies.
These priorities, endorsed by the ACT EU Steering Group, take into account feedback received via the public health emergencies and MSP kick-off workshops in June 2023.
- Publication date
- 10 November 2023
- European Medicines Agency