COMBINE programme launches phase 2 of the pilot coordinated assessment procedure for combined studies

The European Commission has launched the second phase of the COMBINE coordinated assessment pilot. Phase 2 is expected to remain open for at least one year, expands the scope of studies eligible to participate, and introduces a rolling process with monthly slots for the submission of expressions of interest.

Scope now includes: 

Multinational investigational medicinal product (IMP) clinical trials combined with:

• Performance studies of IVDs or companion diagnostics requiring authorisation
• Clinical investigations of medical devices requiring authorisation

Combined studies with Advanced Therapy Medicinal Products (ATMPs)

Sponsors must submit their expressions of interest by the 23rd of the month preceding the month in which they intend to submit their application. The first monthly application window will open in September 2026. To apply to the September round, sponsors must submit their expressions of interest by 23 August 2026.

Learn more on the European Commission website.