European Commission sets new clinical trial targets for the EU

The European Commission, the Heads of Medicines Agencies (HMA), and the EMA have jointly developed two new targets for clinical trials, to monitor progress against the ambition of making the EU a more attractive destination for clinical research and to improve timely access to innovative medicines for patients. The aim is that, in the coming five years:

• An additional 500 multinational clinical trials are added to the current average of 900 that are already authorised each year (i.e. an estimated additional 100 per year);

• Two thirds (66%) of clinical trials should begin recruiting patients within 200 calendar days or less from the date of submission of an application for approval of the clinical trial. This is in comparison to the current 50% of clinical trials.

 These goals build on the Authorities’ ongoing efforts to create a more supportive environment for clinical research. A key part of this is the Accelerating Clinical Trials in the EU (ACT EU) initiative which seeks to optimise how clinical trials are designed and run.

Although the acronyme ACT is included in its title, ACT EU is not a legislative provision. It is rather an initiative that is intended to support smarter clinical trials through regulatory, technological and process innovation. The regulatory bodies launched ACT EU in 2022 with the aim of creating a more favorable clinical trial environment.

It uses recommendations from the EU’s medicines agencies network strategy and the European Commission’s Pharmaceutical strategy for Europe to propose regulatory changes that encourage clinical trial research.