Clinical trial applications advice pilot becomes permanent

The Accelerating Clinical Trials in the EU (ACT EU) advice pilot, which helps sponsors prepare clinical trial applications, will become a permanent initiative from January 2027. The initiative contributes to higher-quality applications and more efficient clinical trial assessment processes, by strengthening cooperation across the European medicines regulatory network.

The advice procedure, coordinated by the Heads of Medicines Agencies (HMA) through its Clinical Trials Coordination Group (CTCG), provides sponsors with technical and regulatory support before they submit a clinical trial application through the Clinical Trials Information System (CTIS). Since its launch in 2024, the pilot has helped sponsors improve the quality of their applications by providing consolidated feedback from the Member States concerned on key pre-submission topics.

Before the introduction of this pilot, sponsors could only receive technical and regulatory support at a national level from the Member State responsible for evaluating their application.

The transition to a permanent initiative will ensure continued support for sponsors seeking guidance before submitting clinical trial applications through CTIS. 
ACT EU will continue to manage applications already submitted under the pilot until the end of 2026. A final report summarising lessons learned from approximately 30 pilot applications will be published before the end of 2026. Updated guidance documents and templates for sponsors will be made available on the CTCG website in January 2027.

The transition to a permanent initiative supports the objectives of the European Biotech Act by helping clinical trial sponsors navigate the EU clinical trials framework more effectively.

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