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Guideline on Benefit-Risk Assessment of Health Products and Technologies

The purpose of this guidance is to provide a framework for the sponsors, drug developers, reviewers, marketing authorization holders and researchers to systematically evaluate, report and communicate the balance between benefits and risks of a medicinal product in a standardized format. This guidance also includes the decision-making framework at the end of a benefit risk assessment.

This guidance applies to:

1. New Chemical Entities and Health Products Technologies assessment.
2. Marketed drugs with a new safety signal or a new indication.
3. Clinical trials.

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