The first results from the (Facilitating and Accelerating Strategic Clinical Trials in the EU (FAST-EU) Pilot programme have been published by the Heads of Medicine Agency (HMA). Initial results indicate strong interest and engagement from stakeholders and the possibility of a 70-calendar-day approval timeline for clinical trial applications, indicating operational plausibility for the upcoming Biotech Act in the context of clinical trials.
FAST-EU is a new initiative agreed in November 2025 by the HMA, the Clinical Trial Coordination Group (CTCG) and MedEthics EU, with the aim of reducing the maximum overall timeline of 10 weeks from Clinical Trials Information System (CTIS) submission to final conclusion for multinational clinical trial applications, without modifying any legal rights or obligations. In turn, this aims to provide predictability and efficiency of assessment timelines, strengthen cooperation between European member states and provide timely access to patients for innovative therapies.
The results detailed 68 expressions of interest submitted by sponsors, leading to the selection of 15 multinational clinical trials (Phase I – III) across several therapeutic areas. There are 26 EU and European Economic Area (EEA) countries participating, and the first three procedures have been completed within the 10-week timeline for coordinated approval. A more comprehensive report is expected, which will provide feedback on coordination activities, the application of reliance procedures and the integration of the Ethics Committee.
The pilot is seen as a test run for streamlined clinical trial applications, which are a key part of the proposed Biotech Act I. Aspects of the pilot are expected to inform decision-making by the European Commission on the Biotech Act, which is expected to be adopted later this year. The Act proposes to amend the Clinical Trials Regulation (CTR), including measures such as providing faster and simplified approval process, cutting authorisation timelines down from around 106 to 75 days (47 days where no requests for additional information are made), and the removal of the 50-day Additional Period for Review of Clinical Trials Involving Advanced Therapy Medicinal Products (ATMPs) under the CTR.
Initial positive results indicate that such reductions in approval timelines are feasible and can support Europe moving away from being considered as slow and fragmented for clinical research, back towards a competitive global landscape. In 2013, Europe accounted for 22% of global trials; this has since dropped to 12% by 2023, translating to 50,000 fewer patients accessing a trial involving a country within the EEA according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Sponsors can continue to express their interest via the following route through sending the Expression of Interest Template to FAST-EU@hma.eu.
