COMBINE Project 1: coordinated assessment of combined study applications across clinical trial and medical device across multiple Member States
In the EU, there are regulatory requirements for the individual authorisation processes of clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostics (IVDs).
One of the projects in the COMBINE programme involves a pilot to test a new, more efficient way of approving combined studies.
The European Commission, EU Member States and the EMA have launched this pilot to allow sponsors to test a medicine and a companion diagnostic at the same time to submit a single application, ensuring more harmonised interactions with the Member States involved.
The European Commission, participating Member States and the European Medicines Agency (EMA) launched the first phase of the pilot 'all-in-one' coordinated assessment procedure on 13 June 2025. The call for sponsors to express their interest will remain open until 31 August 2025. This phase will accept a limited number of combined study applications which involve:
- a clinical trial of a medicinal product
- a simultaneous performance study of an in vitro diagnostic medical device run by the same sponsor.
All sponsors who express interest will be contacted no later than 31st October, to confirm whether their combined study has been selected.
Combined studies - European Commission
COMBINE Project 1 – pilot “all-in-one” coordinated assessment - European Commission