El programa COMBINE lanza la fase 2 del piloto de evaluación coordinada
On 26 June 2026, the European Commission, together with EU Member States, launched Phase 2 of the COMBINE coordinated assessment pilot, further advancing the integration of regulatory pathways for combined medicinal product–device studies.
Building on Phase 1 experience, this next phase introduces an expanded scope and a more flexible submission process, aiming to streamline regulatory procedures while maintaining robust oversight.
Combined medicinal product–device studies have traditionally required parallel regulatory pathways, often leading to fragmentation and delays.
The COMBINE pilot enables sponsors to submit a single application for a coordinated assessment across medicinal product and device frameworks, aiming to streamline authorisation, reduce administrative burden, and accelerate patient access to innovative therapies.
Key Updates
Expanded scope of eligible studies
Phase 2 now includes combined studies involving:
- Investigational medicinal products (IMPs) with medical device clinical investigations
- IMPs with IVD performance studies or companion diagnostics
- Advanced Therapy Medicinal Products (ATMPs) in combination scenarios
More flexible and continuous process
A rolling application system has been introduced, with monthly submission opportunities for expressions of interest.
Support for different study setups
The pilot allows single or separate sponsors, as well as exploration of joint protocols and shared documentation.
Further developments planned
Additional features, such as procedures for substantial modifications and further procedural alignment, will be introduced later in Phase 2.
Timeline
- Sponsors must submit an expression of interest by the 23rd of the month preceding application
- First application window: September 2026
- Deadline for first round: 23 August 2026
Additional Resources
An updated Sponsor Guide for Phase 2 is available, providing detailed information on eligibility criteria, submission processes, and procedural requirements for participation in the COMBINE pilot.
Sponsors considering participation are encouraged to consult the guide to prepare their expression of interest and study documentation.
What Does This Mean for You?
Sponsors of combined studies should consider the COMBINE pilot as an opportunity to simplify regulatory interactions and align study submissions across frameworks, particularly for complex or innovative products.
This is especially relevant for studies involving multiple Member States, where coordinated assessment can reduce fragmentation and duplication of regulatory processes.
QbD Group can support you in assessing the applicability of the COMBINE pilot, preparing submissions, and aligning regulatory and clinical strategies to optimise your study pathway.
Feel free to reach out if you would like to discuss how this pilot could support your development strategy.