EMA: Harmonisation of Combination-Product Quality Assessment
EMA’s Combination Products Operational Group (COMBO) is working to improve alignment between notified body opinions (NBOps) and pharmaceutical quality assessment, according to its report on the meeting held on 8 October 2026.
Discussions focused on assessment responsibilities, expectations for applicant data and potential overlaps between the medicinal-product and medical-device frameworks. The group plans to continue its work through a joint review of Team-NB’s NBOp template.
The report introduces no new requirements but signals further clarification of the interface between the two assessment processes.
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