Last updated: 27 June 2025
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What is COMBINE?
COMBINE is one of the initiatives highlighted in the Draghi report to support EU competitiveness in clinical research.
- As part of the COMBINE programme, the European Commission and EU Member States have launched a pilot project to test a new, more efficient way of approving combined studies.
- These studies involve both clinical trials of medicines and performance studies for medical devices.
When did the COMBINE Project 1 – pilot launch?
The European Commission, participating Member States and the European Medicines Agency (EMA) announce the launch of the first phase of the pilot on 13 June 2025.
What will phase 1 of the COMBINE Project 1 pilot explore?
Phase 1 of the pilot will explore the feasibility of a coordinated assessment procedure. This will involve using CTIS for applications which involve a multinational clinical trial of a new investigational medicine and a performance study of an in vitro diagnostic medical device. To participate in the pilot, the same sponsor must be running the clinical trial and performance study1.
This ‘all-in-one’ coordinated procedure is expected to:
- streamline the authorisation process
- reduce administrative burden for sponsors
- accelerate patient access to innovative treatments.
Where can you find more information on the structure of the project?
The COMBINE Project 1 Outline document provides further information on the structure of the pilot.
Where can you find further information on the eligibility criteria and the pilot process?
The Sponsor guide explains both eligibility criteria and the pilot process.
What are the steps for sponsors wishing to express an interest in participating in the COMBINE project 1 pilot?
- complete the expression of interest form
- prepare the synopsis of proposed combined study
- create an EMA account and request access to Eudralink to EMA’s service desk. Once granted access to Eudralink, users will be able to create packages to include all the requested documents
- submit the expression of interest form and protocol synopsis to EUcombinepilot@ccmo.nl including Eudralink with the two documents (expression of interest form and protocol synopsis)
- if you already own an EMA account (username@id.ema.europa.eu) you need to modify this using your professional or personal email address.
When will the call for expression of interest close?
The call for expression of interest will close on 31 August 2025.
Source: European Commission (eNews), European Commission
References
1. Clinical trials involving IVD performance studies – coordinated assessment pilot, 27 June 2021, HPRA