The initiative

About the initiative

The Accelerating Clinical Trials in the EU (ACT EU) initiative was launched in January 2022 by the European Commission, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA). 

ACT EU is a multi-annual programme aiming to create a favourable environment for research and development in life sciences, through harmonisation, innovation and collaboration with stakeholders. 

ACT EU builds on momentum of the Clinical Trials Regulation (CTR) and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022. The initiative will deliver on the clinical trial innovation recommendations of the European medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe.

The European Commission, EMA and HMA run the initiative together, via a steering group established in March 2022.

 

Objectives and priority actions

The programme's strategy paper lays out the high-level regulatory network objectives and features ten priority action areas that are the basis for the ACT EU workplan.

Accelerating Clinical Trials in the EU (ACT EU) Strategy Paper 

More details in “Priority action areas”. 

The ACT EU Steering Group recognises that additional EU public funding may be required to achieve ACT EU’s objectives. Two priority areas for such potential funding have been identified:

1. Supporting academic sponsors in conducting multinational clinical trials;
2. Delivering a clinical trials data analytics research agenda.

Further details are available in the document.

 

Workplan

The ACT EU workplan sets out deliverables and timelines for the programme for 2023-2026.

The workplan is reviewed on a regular basis and revised to better address stakeholder priorities.