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ACT EU pre-submission advice pilot for clinical trials to become permanent in January 2027

🇸🇰 ŠÚKL · Thu 29 Oct 2026

The EU-level advisory scheme for sponsors preparing clinical trial applications will move from pilot to permanent status, with a final report on about 30 applications due by the end of 2026.

Slovakia's medicines agency, ŠÚKL, has announced that the advisory pilot run under the Accelerating Clinical Trials in the EU (ACT EU) initiative will become a permanent initiative from January 2027. The pilot supports sponsors in preparing clinical trial authorisation applications.

The procedure is coordinated by the Heads of Medicines Agencies (HMA) network through the Clinical Trials Coordination Group (CTCG). It gives sponsors scientific and regulatory support before they submit an application through the Clinical Trials Information System (CTIS). The stated aim is to improve application quality and make assessment more efficient through closer cooperation between European medicines regulators.

According to the notice, application quality has improved since the pilot began in 2024. It credits consolidated comments and recommendations from the member states concerned, which flag key issues to resolve before submission. Previously, sponsors could obtain such support only at national level, from the member state responsible for assessing the application.

ACT EU will continue to handle applications submitted under the pilot until the end of 2026. A final report summarising the experience gained from assessing about 30 applications is planned for that period. Updated guidance and document templates for sponsors will be published on the CTCG website in January 2027.

What it means for your team

  • Sponsors planning EU clinical trial applications can expect pre-submission scientific and regulatory advice to be a standing option from January 2027, not a time-limited pilot.
  • The service is coordinated at EU level by HMA via the CTCG, so teams should not treat it as only a national Slovak offering.
  • Regulatory teams should watch for the pilot's final report and for the updated CTCG guidance and templates due in January 2027, as these will set out how the permanent scheme works.
  • The source gives no detail on scope, eligibility or timelines for the permanent scheme, so these should be checked once the CTCG guidance appears.

Official source: ŠÚKL ↗

Article written by VigiEye from the official source (ŠÚKL). AI-assisted; check the source before acting.

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