EMA's ACT EU Clinical Trial Advice Pilot Becomes Permanent in January 2027
- The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which provides pre-submission regulatory and technical guidance to trial sponsors, will transition to a permanent program starting January 2027.
- Since launch in 2024, the pilot has processed approximately 30 applications, delivering consolidated multi-Member State feedback that improves application quality and accelerates EMA assessment timelines.
- Updated guidance documents and templates will be published in January 2027 to support sponsors navigating the EU clinical trials framework under the permanent initiative.
Operational Impact
CRO regulatory and trial-management teams can now plan sustained engagement with EMA's consolidated pre-submission advice process, reducing application rework cycles and improving first-submission acceptance rates across EU trials.
Source: EMA News and Press RSS