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ACT EU makes clinical trial application advice pilot a permanent service from January 2027

🇪🇺 ACT EU · Tue 03 Nov 2026

The pre-submission advice procedure for sponsors using CTIS, run since 2024 as a pilot, will continue beyond 2026 with updated guidance and templates.

ACT EU has confirmed that its advice pilot for clinical trial applications will become a permanent initiative from January 2027. The service gives sponsors technical and regulatory support before they submit an application through the Clinical Trials Information System (CTIS).

The procedure is coordinated by the Heads of Medicines Agencies (HMA) through its Clinical Trials Coordination Group (CTCG). Since the pilot launched in 2024, sponsors have received consolidated feedback from the Member States concerned on key pre-submission topics. Previously, sponsors could obtain technical and regulatory support only at national level, from the Member State responsible for evaluating their application.

ACT EU says the initiative contributes to higher-quality applications and more efficient assessment by strengthening cooperation across the European medicines regulatory network. It also links the move to the objectives of the European Biotech Act, saying it helps sponsors navigate the EU clinical trials framework.

On the transition, ACT EU will continue to manage applications already submitted under the pilot until the end of 2026. A final report on lessons learned from about 30 pilot applications is due before the end of 2026. Updated guidance documents and templates for sponsors will appear on the CTCG website in January 2027.

What it means for your team

  • Sponsors planning CTIS submissions can build consolidated pre-submission advice from the Member States concerned into their 2027 timelines.
  • Watch for the final pilot report before the end of 2026, which should show the lessons learned from about 30 applications.
  • Check the CTCG website in January 2027 for updated guidance and templates, and revise internal submission procedures accordingly.

Official source: ACT EU ↗

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

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