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 2026 and 2027 and outlines the fundamental role of ACT EU's regulatory partners involved in clinical trials.
The workplan serves to improve the landscape for clinical research in 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.
Additionally, the workplan outlines several new focus areas. They include:
The additional focus areas are in line with the updated ACT EU objectives.
EMA, the European Commission and the Heads of Medicines Agencies (HMA) published the revised workplan in May 2026.
For more information, see:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in May 2026.
27 May 2026
Added information about new focus areas in the workplan section.