Clinical trial applications advice becomes permanent from 2027

The clinical trial applications advice pilot run by the Accelerating Clinical Trials in the EU (ACT EU) initiative becomes permanent from January 2027. Sponsors preparing a trial application can receive consolidated feedback from the Member States concerned before they submit through the Clinical Trials Information System (CTIS). Before the pilot, sponsors could only get this kind of support at national level, from the Member State evaluating their application.

Clinical trial applications advice: what changes in 2027

The advice procedure is coordinated by the Heads of Medicines Agencies through its Clinical Trials Coordination Group (CTCG). ACT EU will keep managing applications already submitted under the pilot until the end of 2026. A final report on lessons from roughly 30 pilot applications is due before then, and updated guidance and templates for sponsors will appear on the CTCG website in January 2027.

Why it matters

Pre-submission advice only helps if sponsors use it early, so a standing service gives companies a predictable route to feedback before filing. The agency’s stated aim is higher-quality applications and more efficient assessment. The 2026 report will show whether that holds across the pilot’s roughly 30 files, and it is worth reading if you plan trials under CTIS. The move also supports the European Biotech Act, which the agency names as the wider policy context.