EMA · Programme announcement
EMA announces permanent clinical-trial application advice from January 2027
Official source date: · Source checked
The ACT EU advice pilot will become a permanent initiative in January 2027, continuing technical and regulatory support for sponsors preparing applications through CTIS.
Who should review this?
Clinical-trial sponsors, regulatory affairs teams and application coordinators working with CTIS.
What it means for pharmaceutical teams
The initiative provides consolidated technical and regulatory advice before application submission. ACT EU will manage existing pilot applications until the end of 2026, with updated sponsor guidance and templates planned for January 2027.
Practical review checklist
PharmaEdges reading prompts for your own applicability review:
- Review whether pre-submission advice would help resolve questions in your application.
- Check the CTCG guidance and templates when planning a January 2027 request.
- Keep advice requests separate from the application authorisation process.
Official source and verification
Read the EMA source (opens in a new tab)
This article summarises the linked official material. The context and checklist are PharmaEdges explanatory commentary, not additional regulatory requirements. The source publication date is separate from this article’s publication date.
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