The first report on the state of clinical trials in Europe, published jointly by the European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) in mid-May, provides an overview of active clinical trials in the first quarter of 2026 and compares current performance with the objectives established under the Accelerating Clinical Trials in the EU (ACT EU) initiative. These targets are also aligned with the proposed EU Biotech Act, currently under review by European co-legislators, and form part of broader efforts to position the European Union as a preferred destination for clinical research while ensuring timely patient access to innovative treatments.
Increase in Multinational Clinical Trials
The first quarter of 2026 recorded an increase in the number of multinational clinical trials, with nineteen more trials authorized than the historical average. This brings the EU closer to its goal of achieving 500 additional multinational clinical trials by 2030, a target that would require the activation of at least 100 new multinational studies per year.
March 2026 recorded the highest number of multinational trial authorizations, with 110 studies approved. Patient recruitment performance also showed improvement, with approximately 40% of studies enrolling the required number of participants within 200 days of the authorization application. The target for 2030 is 66%.
Key Findings of the Report
The report identified a total of 668 clinical trial applications, the majority of which (416) were single-country studies. Among these, non-commercial studies predominated (262).
The opposite trend was observed for multinational trials (252), which were mainly commercial studies (229). A total of 538 authorized studies were monitored in the report, showing a more balanced distribution between multinational trials (232) and single-country trials (306).
The data were obtained from the Clinical Trials Information System (CTIS) and relate to studies falling within the scope of Regulation (EU) No. 536/2014 on clinical trials.
During the first quarter of 2026, an average of 208 applications per month for new clinical trials were submitted through CTIS. The average time from submission to authorization for a new early-phase clinical trial was 118 days.
Since its launch, CTIS has received more than 13,000 clinical trial applications. At the time of publication of the report, approximately 6,400 early-phase clinical trials were ongoing in the EU/EEA under the Clinical Trials Regulation framework.
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