Today, the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched the ACT EU. This is an initiative to transform how clinical trials are initiated, designed and run. It is named Accelerating Clinical Trials in the EU (ACT EU).
The aim is to further develop the EU as a focal point for clinical research, further promote the development of high quality, safe and effective medicines, and to better integrate clinical research in the European health system.
Building on the application of the Clinical Trials Regulation and the launch of the Clinical Trials Information System (CTIS) on 31 January 2022, 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 ACT EU strategy paper published today lists ten priority actions for 2022/2023, including enabling innovative trial methods, establishing a multi-stakeholder platform, and supporting the modernisation of good clinical practice. Together, they will contribute to achieving the ambitious goals for innovation in clinical trials set out in the European medicines agencies network strategy (EMANS) to 2025 and the European Commission’s Pharmaceutical Strategy.
ACT EU will be co-led by the EC, EMA and the HMA, who have also collaboratively developed the initiative.
The proposal to establish ACT EU was endorsed by HMA in November and by EMA’s Management Board in December 2021. Further information will be made available on EMA and HMA webpages.