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Consolidated advice pilots

In Q2 2024, ACT EU is launching two pilots offering: a) harmonised scientific advice to support the submission of marketing authorisation and clinical trial applications (CTAs) in the EU, and b) consolidated technical/regulatory advice on CTA dossiers prior to their submission in CTIS.

date:  11/04/2024

The aim is to facilitate the development of safe and effective medicines, benefitting patients in the EU. Learnings from the pilots will be used to further consolidate and streamline scientific advice on clinical trials.

More information on the pilots will be available in due course on the ACT EU website.