Call for interest launched for COMBINE pilot exploring the feasibility of coordinated assessment across EU Member States for combined studies

Call for interest for COMBINE pilot is now launched in COMBINE project 1 and the sponsors of combined studies are encouraged to express their interest to participate. A webinar for interested sponsors will be hosted 20 June 2025, 2-4pm CEST. Please find details on the webinar, eligibility criteria and pilot process on the European Commission COMBINE Project 1 dedicated subpage: COMBINE Project 1 – pilot “all-in-one” coordinated assessment - European Commission.

COMBINE Project 1 is a cross-sector project under the COMBINE programme and is exploring the feasibility of a coordinated assessment of combined study applications across the clinical trial and medical device regulatory frameworks and across multiple Member States. It is expected to streamline the authorisation process, reduce administrative burden for sponsors and accelerate patient access to innovative treatments.

The Danish Medicines Agency is responsible for coordinating EU collaboration under the COMBINE programme: Combined studies - European Commission