05/20/2026  |  Ferdous Al-Faruque  |  RAPS/Regulatory Affairs Professionals Society

https://www.raps.org/resource/report-eu-makes-progress-toward-2030-clinical-trial-goals.html 

The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.

The report was published on 20 May and is based on data from the Clinical Trials Information System (CTIS) between January and the end of March. The report includes numerous details and statistics pertaining to clinical trials in the economic bloc and notes that last quarter, 208 new clinical trial applications were submitted per month in CTIS and the median time from submission to decision was 118 days.

The key performance indicators (KPIs) were measured against the 2025 clinical trial targets, including the aim of adding 500 multinational trials by the end of 2030, which means the EU hopes to attract at least 100 extra trials to the region every year and 25 trials per quarter. Ultimately, the EU hopes to attract 86 trials every month to account for trial fluctuations.

The report found that 2,830 trials were active during the first quarter of 2026, slightly below the 2,836 target. It also noted that 58 multinational trials were authorized in January, 84 in February, and 110 in March.

The second KPI in the report measured the percentage of clinical trials that recruited patients at the first clinical investigator site in the region within 200 days of submitting the clinical trials application. The KPI is intended to be an indicator of faster access to treatments for patients.

The report found that about 40% of the total number of clinical trials recruited patients within the target timelines, which the EU aims to be 66% by 2030.

"The publication of these key performance indicators marks an important step toward greater transparency and accountability in the EU clinical trials landscape," said EMA in a statement. "It directly responds to stakeholder calls for clearer, evidence-based insights into system performance and progress.

"Moving forward, progress toward the EU clinical trials targets will be reviewed annually by the ACT EU governance, on the basis of the findings from the quarterly reports," the agency added. "This will ensure that the targets remain ambitious, achievable and aligned with the shared goal of making the EU a more attractive environment for high-quality clinical research."

EMA said the clinical trial targets are aligned with the EU Biotech Act proposed by the Commission, but one key change under the initiative is accelerating clinical trial authorizations across countries. The agency added that other initiatives, such as HMA's Facilitating and Accelerating Strategic Clinical Trials (FAST-EU) pilot, which helps sponsors test shorter evaluation timelines for multinational trials within the existing legal framework, are helping the region meet its clinical trial targets.

"Preliminary data collected after March 2026 indicate a continuing positive increase across key indicators, suggesting further progress towards the EU targets," said EMA. "The next quarterly report will provide detailed information on these trends.

"This first quarterly report incorporating the new clinical trial goals has been published on the Accelerating Clinical Trials in the EU (ACT EU) initiative website," the agency added.