The European Medicines Agency said its Accelerating Clinical Trials in the EU (ACT EU) advice pilot will become a permanent initiative from January 2027. The procedure, coordinated by the Heads of Medicines Agencies through its Clinical Trials Coordination Group, gives sponsors consolidated technical and regulatory feedback from the Member States concerned before they submit a clinical trial application through the Clinical Trials Information System. Since its 2024 launch the pilot has handled roughly 30 applications, and a final lessons-learned report is due before the end of 2026, with updated guidance and templates landing on the CTCG website in January 2027.
EMA makes clinical trial advice pilot permanent from 2027
The European Medicines Agency will make its clinical-trial advice pilot permanent from January 2027, locking in consolidated pre-submission feedback for sponsors filing through the EU's trial system.
Why it matters: The move cuts regulatory friction for drug developers running multi-country trials in the EU, supporting the European Biotech Act's push to keep clinical research competitive.
Data as of EMA announcement October 8, 2026. Single-sourced from the agency's own release; underlying pilot documents not independently opened.
Sources
- Clinical trial applications advice pilot becomes permanent · European Medicines Agency · 2026-10-08