Accelerating Clinical Trials in the EU (ACT EU)
Table of contents
The Accelerating Clinical Trials in the EU (ACT EU) initiative aims to develop the European Union further as a competitive centre for innovative clinical research. ACT EU seeks to deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe.
ACT EU builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System's (CTIS) launch on 31 January 2022.
The European Commission, EMA and Heads of Medicines Agencies (HMA) launched ACT EU in January 2022 and run the initiative together, establishing a steering group in March 2022.
The ACT EU workplan sets out deliverables and timelines for the programme for 2022-26.
The deliverables for 2023 include the following:
- Establishing a process to support academic sponsors in enabling large multinational clinical trials
- Supporting clinical trial sponsors to make best use of available CTIS and CTR training activities
- Setting up a multi-stakeholder platform to facilitate dialogue between clinical trial stakeholders, including patients, healthcare professionals and academia
- Modernising good clinical practice by supporting the adoption and implementation of revised EU guidelines in clinical trial design
- Facilitating innovation in clinical trial methods by publishing a methodology roadmap and further developing guidance on decentralised clinical trials
EMA, the European Commision and the Heads of Medicines Agencies (HMA) published the workplan in August 2022.
The programme's strategy paper features ten priority action (PA) areas that are the basis for the ACT EU workplan.
The PAs are listed and detailed below.