From January 2027, the ACT EU advice pilot will become a permanent initiative supporting sponsors in preparing clinical trial applications.
Launched in 2024 under Accelerating Clinical Trials in the EU (ACT EU), the service provides technical and regulatory support before submission through the Clinical Trials Information System (CTIS).
Its added value lies in coordination: the procedure, coordinated by the Heads of Medicines Agencies (HMA) through the Clinical Trials Coordination Group (CTCG), enables sponsors to receive consolidated feedback from the Member States concerned on key pre-submission topics.
The aim is to improve application quality and make assessment processes more efficient, strengthening collaboration across the European medicines regulatory network.
Next steps:
• By the end of 2026: publication of a final report summarising lessons learned from approximately 30 pilot applications.
• From January 2027: updated guidance documents and templates available on the CTCG website.
For sponsors, this is an opportunity to address relevant technical and regulatory issues ahead of submission and navigate the EU clinical trials framework more effectively.
