EU clinical trial pilot to become permanent in January 2027
The EU’s ACT EU clinical trial advice pilot will become permanent, providing technical and regulatory assistance to applicants
The Accelerating Clinical Trials in the EU (ACT EU) advice pilot will become a permanent initiative from January 2027, ensuring continued technical and regulatory support for sponsors preparing clinical trial applications.
Launched in 2024, the pilot aims to improve application quality and streamline clinical trial assessments across the European Union. Coordinated by the Heads of Medicines Agencies (HMA) through the Clinical Trials Coordination Group (CTCG), the initiative provides sponsors with consolidated feedback from concerned member states before applications are submitted through the Clinical Trials Information System (CTIS).
Previously, sponsors could only obtain such guidance at the national level from the responsible national authority for assessing their applications.
The transition follows experience gained from approximately 30 pilot applications. A final report outlining key lessons learned will be published by the end of 2026, while updated guidance documents and templates will become available on the CTCG website in January 2027.
Existing pilot applications will continue to be managed under ACT EU until December 2026.
The permanent initiative also supports the objectives of the European Biotech Act by strengthening regulatory cooperation, simplifying application preparation and helping sponsors navigate the EU clinical trials framework more efficiently.