COMBINE Project 1 is exploring the coordinated assessment of combined study applications across the clinical trial and medical device regulatory frameworks as well as across multiple Member States. This 'all-in-one' coordinated procedure is expected to:
- streamline the authorisation process
- reduce administrative burden for sponsors
- accelerate patient access to innovative treatments.
COMBINE project 1 pilot
The project proposes a phased pilot approach to test the feasibility of such a coordinated process. The pilot is designed to allow sponsors of combined studies to submit a single application for coordinated assessment. The COMBINE Project 1 Outline document provides further information on the structure of the pilot.
The European Commission, participating Member States and the European Medicines Agency (EMA) are pleased to announce the launch of the first phase of the pilot on 13 June 2025. This phase will accept a limited number of combined study applications which involve a clinical trial of a medicinal product, and a simultaneous performance study of an in vitro diagnostic medical device run by the same sponsor.
Resources
The Sponsor guide explains both eligibility criteria and the pilot process.
A webinar was held on 20 June 2025 for potential sponsors to learn about the pilot from the COMBINE Project 1 competent authority leads, hear about resources available and how to respond to the ‘call for expression of interest’.
Submission of an expression of interest
Sponsors interested in participating in the COMBINE project 1 pilot should:
- 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 [dot] nl (EUcombinepilot[at]ccmo[dot]nl) including Eudralink with the two documents (expression of interest form and protocol synopsis) - if you already own an EMA account (usernameid [dot] ema [dot] europa [dot] eu (username[at]id[dot]ema[dot]europa[dot]eu)) you need to modify this using your professional or personal email address.
Please note:
- EUcombinepilotccmo [dot] nl (EUcombinepilot[at]ccmo[dot]nl) mailbox is only for the expression of interest. Any other submissions or questions not related to this will be returned
- EUcombinepilotccmo [dot] nl (EUcombinepilot[at]ccmo[dot]nl) mailbox will be closed after the period of expression of interest has ended
- the CCMO will ensure that the use of personal data complies with the rules and provisions set out in Regulation (EU) 2016/679. Further information is provided in the privacy statement within the expression of interest form
- information about the selected applications for the pilot will be shared via the (proposed) reporting Member State (RMS) of the applications.
The call for expression of interest will close on 21 September 2025 (extended from previous deadline of 31 August 2025). Preference will be given to early submissions and to applications which involve a broad set of concerned Member States.
All sponsors who express interest will be contacted no later than 31st October, to confirm whether their combined study has been selected.
