FAST-EU pilot points to a faster future for multinational clinical trials in Europe
A new European pilot project, FAST-EU, is beginning to demonstrate that multinational clinical trials in Europe can be authorised substantially faster than under current timelines—without lowering scientific, ethical, or safety standards. The initiative, launched in early 2026 by EU member states together with the European Medicines Agency (EMA) and the European Commission, aims to test whether coordinated trial approvals across multiple countries can realistically be completed within 70 calendar days.
The project comes in response to growing concerns that Europe is falling behind competitors such as the United States, China, and Australia in attracting and launching innovative clinical trials. While Europe remains a major centre for biomedical research, fragmented procedures and slower authorisation timelines have long been seen as barriers to competitiveness and investment.
FAST-EU is closely linked to the broader objectives of the proposed European Biotech Act, which seeks to accelerate clinical research, simplify regulation, and strengthen Europe’s life sciences ecosystem. Under the Biotech Act proposal, standard timelines for multinational clinical trial authorisations could eventually fall from around 106 days today to approximately 75 days—or even 47 days in some cases where no additional information is requested from sponsors.
However, because the Biotech Act is still under negotiation and may take years to fully enter into force, regulators decided to begin testing practical solutions immediately through the FAST-EU pilot. The project has introduced new coordination mechanisms and more parallelised assessment processes to determine whether substantially faster timelines are operationally feasible under the existing regulatory framework.
Early results appear encouraging. According to project updates, 68 expressions of interest were received from sponsors, with 15 procedures selected for participation so far. The studies span Phase I to Phase III development and involve an average of more than seven participating member states, with some trials covering as many as 14 countries. The first three multinational procedures have already been completed within—or very close to—the 70-day target timeframe.
The pilot is also beginning to show signs of wider impact. European Commission officials report that multinational clinical trial authorisations in the EU reached 252 in the first quarter of 2026, compared to a historic quarterly average of 233, suggesting renewed momentum in Europe’s clinical research environment.
If FAST-EU continues to deliver positive results, it could become an important foundation for future implementation of the Biotech Act and a broader shift toward a more coordinated, competitive, and innovation-friendly European clinical trials system—particularly relevant for complex and emerging therapeutic areas that depend on efficient multinational research pathways.
