8 October 2026
European Medicines Agency: 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.
For more information, see here.
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