COMBINE Project 1 – pilot “all-in-one” coordinated assessment

COMBINE Project 1 is exploring the coordinated assessment of combined study applications across:

• clinical trial and medical device regulatory frameworks
• 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 – Phase 2 

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 European Commission, participating Member States and the European Medicines Agency (EMA) are pleased to announce the launch of the second phase of the pilot on 26 June 2026. 

This phase expands the scope of accepted applications and will extend the expression of interest period (this pilot phase will remain open for at least one year). 

For this pilot phase, combined study applications should involve:

• a medicinal product clinical trial combined with
  • an in vitro diagnostic medical device simultaneous performance study conducted by either the same eligible sponsor or separate sponsors, or 
  • a medical device clinical investigation conducted by either the same eligible sponsor or separate sponsors. 

Resources

The Sponsor guide explains both eligibility criteria and the pilot process.

An overview of the key features of phase 2 is outlined in the Stakeholder Presentation from 28^th May 2026.

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 the 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 EUcombinepilotccmo [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 first procedures for Phase 2 will begin in September 2026. The cut-off for expressions of interest will close on the 23^rd of  the previous month; for example, a sponsor wishing to submit their application in September will need to submit the expression of interest by 23^rd August (see the table below).

Sponsors should be ready to submit the combined study in the month after the application is accepted. Preference will be given to applications which involve a broad set of concerned Member States.

All sponsors who express interest should expect to receive a decision by the end of the month of the submission of the expression of interest. This phase of the pilot will remain open for at least one year; example submission cut-off dates are provided below.

COMBINE Pilot – Phase 1

• the expression of interest period for phase 1 of the COMBINE pilot closed in September 2025 with 8 applications being accepted
• the learnings from the applications in phase 1 were used as a basis for designing phase 2
• a webinar was held on 20 June 2025 for potential sponsors to learn about the first phase of the pilot from the COMBINE Project 1 competent authority leads, to hear about resources available and how to respond to the ‘call for expression of interest’
• some of the information may still be of interest to potential sponsors for phase 2