HTA Regulation: Questions and Answers on general methodological and procedural issues for joint clinical assessments (November 2025)

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This Q&A document provides answers to questions asked by stakeholders on general methodological and procedural issues for the Joint Clinical Assessment process.

The Q&A groups several questions on PICO as well as a separate Annex on how to handle individualised treatment comparators.

This document is based on enquiries received and will be regularly updated.

 

https://health.ec.europa.eu/latest-updates/questions-and-answers-general-methodological-and-procedural-issues-joint-clinical-assessments-2025-12-05_en#share

 

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