European Medicines Agency Reports Growth in Multinational Clinical Research Activity Across the EU

European Medicines Agency Reports Growth in Multinational Clinical Research Activity Across the EU

(IN BRIEF) EMA, together with the European Commission and the Heads of Medicines Agencies, has released the first report measuring progress toward the EU’s 2030 clinical trial targets. The report shows that 19 additional multinational clinical trials have been authorised above historical averages, while 40.5 percent of clinical trials now recruit participants within 200 days of application submission. The initiative is part of wider EU reforms aimed at improving transparency, accelerating clinical research and strengthening Europe’s competitiveness in biotechnology and pharmaceutical innovation.

(PRESS RELEASE) LONDON, 20-May-2026 — /EuropaWire/ — European Medicines Agency, together with the European Commission and the Heads of Medicines Agencies, has published the first progress report tracking advancement toward the European Union’s 2030 clinical trial targets, highlighting early gains in multinational clinical research activity and participant recruitment timelines across the region.

The report, which covers the period from January 1 through the end of March 2026, forms part of the EU’s broader strategy to strengthen its position as a leading global destination for clinical research while improving access to innovative medicines for patients across member states.

According to the findings, 19 multinational clinical trials were authorised above the historical average during the reporting period, marking early progress toward the EU’s long-term objective of adding 500 extra multinational clinical trials by 2030.

The report also indicates improvements in recruitment timelines for clinical studies. Currently, 40.5 percent of clinical trials in the EU recruit participants within 200 days of application submission. The target established for 2030 is to increase that figure to 66 percent.

Regulators noted that preliminary data collected after March 2026 suggest continued positive growth across several key indicators, with additional details expected in future quarterly reports published through the Accelerating Clinical Trials in the EU initiative.

The clinical trial targets align with the proposed EU Biotech Act, which aims to strengthen Europe’s biotechnology and pharmaceutical sectors by accelerating regulatory procedures and improving the efficiency of clinical research authorisation across countries.

Additional initiatives are supporting these reforms, including FAST-EU, short for Facilitating and Accelerating Strategic Clinical Trials, a pilot programme led by the Heads of Medicines Agencies. The initiative allows sponsors to test shorter assessment timelines for multinational clinical trials within the current regulatory framework.

European authorities said the publication of these performance indicators represents a significant step toward improving transparency and accountability in the EU clinical trial system. The initiative also responds to growing calls from industry stakeholders and researchers for clearer, evidence-based insights into the performance and efficiency of Europe’s clinical research environment.

Under the current framework, progress toward the EU clinical trial goals will be reviewed annually by the governance bodies overseeing the ACT EU initiative, based on quarterly performance reports. Regulators said this process is intended to ensure the targets remain both ambitious and achievable while supporting the EU’s broader ambition of becoming a more attractive environment for high-quality clinical research and pharmaceutical innovation.

The reforms come as countries worldwide compete to attract clinical research investment and accelerate the development and approval of new therapies and medical technologies.

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SOURCE: European Medicines Agency

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