The European Medicines Agency (EMA) Management Board was updated on progress in clinical trials across the European Union, noting continued growth in activity under the Clinical Trials Regulation (CTR).
Between its “go live” in early 2022 and the end of May 2026, more than 14,000 clinical trial applications have been submitted under the CTR.
In December 2025, the European Commission adopted its proposal for the Biotech Act, which foresees significant changes to the Clinical Trials Regulation and, consequently, to the Clinical Trials Information System (CTIS) managed by the Agency.
The Board noted the need to allocate resources to prepare for these changes in order to be ready as soon as possible and before the legislative process has been concluded.
The Board also noted progress on the EU’s new clinical trial targets and was updated on recent initiatives aimed at strengthening clinical trials under the Accelerating Clinical Trials in the European Union (ACT EU) programme, as well as other network initiatives, including FAST EU, a pilot led by the Heads of Medicines Agencies (HMA).
An additional 19 multinational clinical trials have been authorised above the historical average, bringing the EU closer to its target of 500 additional multinational trials by the end of 2030.
At present, 40.5% of all clinical trials recruit participants within 200 days from application submission, while the EU target is to reach 66% by 2030.
The new clinical trial targets are aligned with the proposed EU Biotech Act. One of the key changes under this initiative is the acceleration of clinical trial authorisation processes across countries.
Complementary network initiatives are also contributing to these targets.
For example, FAST-EU (Facilitating and Accelerating Strategic Clinical Trials), a pilot led by the Heads of Medicines Agencies, provides sponsors with the opportunity to test shorter evaluation timelines for multinational trials within the existing legal framework.
Clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.
