ACT EU aims to transform how clinical trials are initiated, designed and run to further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.
The initiative 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.
It builds on the Clinical Trials Regulation (CTR) and Clinical Trials Information System's (CTIS) launch on 31 January 2022.
Its strategy paper is available below. It features dedicated priority action areas.
The European Commission, EMA and Heads of Medicines Agencies (HMA) launched ACT EU in January 2022.
For more information, see:
A revision of the ACT EU workplan is available. It covers activities for 2025 and 2026.
The workplan serves to improve the landscape for clinical researchin the European Union.
It reflects feedback received through its multi-stakeholder platform advisory group.
The workplan highlights the following focus areas:
It also features clinical trial analytics, training and communication, that remain integral to ACT EU’s work.
EMA, the European Commision and the Heads of Medicines Agencies (HMA) published the workplan in January 2025.
It outlines the fundamental role of ACT EU's regulatory partners involved in clinical trials.
For more information, see: