The programme has launched two pilot initiatives to facilitate the dialogue between regulators and sponsors or applicants prior to submission of their applications. One pilot aims to reinforce scientific advice coordination between clinical trial approval and clinical trial design, while the second offers pre-clinical trial application advice on regulatory aspects. The pilots will continue in 2026. Once completed, learnings will be published to inform future proposals for advice processes offered by the European medicines regulatory network. The pilots enhance the coordination within the European medicines regulatory network (EMRN) to offer applicantsharmonised adviceon how to improve the quality of their applications for marketing and/or
ACT EU - Accelerating Clinical Trials · May 08, 2026
ACT EU: Consolidated advice on clinical trials
Original title: Consolidated advice on clinical trials
Two pilot initiatives launched to coordinate scientific advice between clinical trial approval and design, and pre-clinical trial application regulatory advice, continuing into 2026.
Published by ACT EU - Accelerating Clinical Trials. HealthSignal links to the original document; the summary above is extracted from the source text.