ACT-EU

Initiative leader: European Medicines Agency (EMA)

Duration: Not determined

ACT-EU will support smarter clinical trials through regulatory, technological and process innovation. The ACT-EU vision is to transform the European Union into a region that supports clinical trial development and enables collaboration and innovation at all stages of the clinical research lifecycle. Seamless coordination among stakeholders, regulators and ethics committees will lead to more cross-border collaboration, and the result will be better, more impactful clinical trials, benefitting patients and healthcare in Europe in the process.

The European Commission, EMA and Heads of Medicines Agencies (HMA) launched ACT EU in January 2022, and run the ACT EU initiative together. 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.

ECRIN's Role in ACT-EU

ECRIN is part of the Multi-Stakeholder Platform Advisory Group, where the role of ECRIN is to represent the academic perspective of (multi-country) clinical trials. This is an important role as ECRIN has been selected to take up this task with 3 other academic representatives. ECRIN is actively involved in specific workshops that are organised on regular basis, and on various topics such as for example Methodology or Clinical Trial Metrics.