Workplan for accelerating clinical trials in the EU

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published the  2022-2026 workplan of the initiative Accelerating Clinical Trials in the EU (ACT EU).

ACT EU, launched in January 2022, seeks to transform how clinical trials are initiated, designed and run. The aim is to further develop the European Union as a focal point for clinical research, promote the development of high-quality, safe and effective medicines, and to better integrate clinical research in the European health system. ACT EU will strengthen the European environment for clinical trials, whilst maintaining the high level of protection of trial participants, data robustness and transparency that EU citizens expect.

The multi-annual ACT EU workplan builds on the  Clinical Trials Regulation (CTR), which became applicable in January 2022, and on the activities of the European regulatory network to support clinical trials. The workplan highlights key focus areas such as innovation in clinical trials, robust methodologies and collaboration across stakeholders.