COMBINE Programme Advances to Second Phase of Coordinated Assessment Pilot for Combined Clinical Trials
The European Commission and EU Member States, including Portugal through Infarmed and the Ethics Committee for Clinical Investigation, have launched the second phase of the coordinated assessment pilot under the COMBINE programme.
According to Infarmed, this new phase expands the integrated procedure to additional types of combined clinical trialsinvolving medicinal products and medical devices.
Expansion of the Pilot Programme
The second phase builds on the first stage of the project, which provided initial experience with coordinated assessment of combined studies through the Clinical Trials Information System.
This new phase introduces a more agile process, including monthly windows for the submission of expressions of interest.
Studies Covered
The second phase now covers multinational clinical trials involving investigational medicinal products combined with clinical investigations of medical devices subject to authorisation.
Combined studies involving advanced therapy medicinal products are also eligible.
Infarmed notes that these combined studies may be promoted by a single sponsor or by different sponsors.
Timeline and Expressions of Interest
The second phase is expected to remain open for at least one year.
Sponsors interested in participating must submit an expression of interest by the 23rd day of the month before the planned submission of the application.
The first monthly submission period will take place in September 2026, with expressions of interest due by 23 August 2026.
Impact on Medical Device and IVD Manufacturers
For medical device manufacturers involved in combined clinical studies, the second phase of the COMBINE pilot is relevant because it supports more coordinated regulatory assessment across the European Union.
Manufacturers and sponsors should pay particular attention to:
combined studies involving medicinal products and medical devices;
clinical investigations of medical devices subject to authorisation;
studies involving advanced therapy medicinal products;
coordination between sponsors where more than one sponsor is involved;
submission planning and monthly expression-of-interest windows;
interaction with CTIS and relevant national authorities;
opportunities to reduce regulatory fragmentation in multinational studies.
For manufacturers developing innovative technologies used alongside medicinal products, the COMBINE pilot may support a more integrated and efficient pathway for the assessment of complex clinical studies in the EU.
For more information, please consult the original Infarmed publication:
https://www.infarmed.pt/web/infarmed/infarmed/-/journal_content/56/15786/13306254
