- Europe
- News Desk
- Source: European Medicines Agency https://www.ema.europa.eu/en/news/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 European Medicines Agency (EMA) said in a notice published on its website. The scheme gives sponsors technical and regulatory support before they file applications through the Clinical Trials Information System (CTIS).
Key facts
How does the advice procedure work?
- The ACT EU advice pilot, launched in 2024, will become a permanent initiative in January 2027, according to the European Medicines Agency.
- The procedure is coordinated by the Heads of Medicines Agencies (HMA) through its Clinical Trials Coordination Group (CTCG).
- ACT EU will continue to manage applications already submitted under the pilot until the end of 2026.
- A final report drawing on lessons from approximately 30 pilot applications will be published before the end of 2026.
- Updated guidance documents and templates for sponsors will appear on the CTCG website in January 2027.
The procedure offers sponsors consolidated feedback from the member states concerned on key pre-submission topics, before they submit a clinical trial application through CTIS. The EMA said the initiative contributes to higher-quality applications and more efficient assessment processes by strengthening cooperation across the European medicines regulatory network.
Before the pilot was introduced, sponsors could receive technical and regulatory support only at national level, from the member state responsible for evaluating their application. The pilot, launched in 2024, was designed to pool that input across the countries involved in a given trial. What happens to applications already in the pipeline?
ACT EU will keep managing applications already submitted under the pilot until the end of 2026. A final report summarising lessons learned from roughly 30 pilot applications is due to be published before the end of that year.
Updated guidance documents and templates for sponsors are to be made available on the CTCG website in January 2027, when the permanent scheme begins. Why does it matter for European drug development?
The EMA said the move 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. The change also ensures continued support for sponsors seeking guidance before they file through CTIS.
The notice was published by the European Medicines Agency, the EU body responsible for the scientific evaluation of medicines, and attributed the coordination role to the Heads of Medicines Agencies and its Clinical Trials Coordination Group. What comes next?
The pilot's remaining applications will be handled by ACT EU until the end of 2026, followed by the publication of the final lessons-learned report before the year closes. Sponsors can expect the updated guidance and templates on the CTCG website in January 2027, the same month the advice procedure becomes a standing part of the EU clinical trials system.
Source: European Medicines Agency
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