The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) are seeing success in their aim to launch 500 extra multinational trials in the region by the end of 2030.
In Q1 2026, the region saw an additional 19 multinational clinical trials authorised in addition to the historical average, as per a report by the bodies evaluating initial progress.
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As well as this, there have been faster recruitment times recorded. Currently, 40.5% of the total number of clinical trials recruit participants within 200 days from application submission. The EU target is 66% by 2030.
Preliminary data collected after March 2026 indicate a continuing positive increase across key indicators, suggesting further progress towards the EU targets, the EMA stated.
The Accelerating Clinical Trials in the European Union (ACT EU) initiative, which was established in 2025, aims to strengthen the EU’s position as a leading destination for clinical research while improving patients’ timely access to innovative medicines. The 500 additional multinational trial target requires 100 more trials to be conducted per year, from 900 to 1,000 annually until 2030.
Analysis by Frontier Economics, published by European Federation of Pharmaceutical Industries and Associations (EFPIA), finds that ACT EU could see a further 35,000 Europeans benefit from access to groundbreaking medical treatments, create 18,000 new jobs and prevent three million sick days.
The new clinical trial targets are also aligned with the EU Biotech Act proposed by the EC. One of the key changes under this initiative is the acceleration of clinical trial authorisation processes across countries.
Facilitating and Accelerating Strategic Clinical Trials (FAST-EU), a pilot led by HMA, is also assisting with the ACT EU target, but providing sponsors with a practical opportunity to test shorter evaluation timelines for multinational trials within the existing legal framework.
Early data from the initiatives show that the EU trials landscape is moving towards improved transparency and accountability. According to the EMA, stakeholders have called 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 to ensure targets remain ambitious, achievable and aligned with the shared goal of making the EU a more attractive environment for high-quality clinical research.
On top of ACT EU and other aforementioned initiatives, the EU has also launched the Clinical Trials Regulation (CTR), which came into full effect in January 2025 following a three-year transition period. In June 2024, experts shared their concerns over the system, with sponsors saying interpretation of the CTR remained a pain point.
According to GlobalData’s “Strategic Intelligence: The State of the Biopharmaceutical Industry 2026 Edition”, EU regulatory data protection (RDP) continues to be a major focal point for pharmaceutical legislation and could create a barrier for the region.
GlobalData is the parent company of Clinical Trials Arena.
