Guideline on Benefit-Risk Assessment of Health Products and Technologies
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- Create Date October 9, 2023
- Last Updated October 9, 2023
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:
- New Chemical Entities and Health Products Technologies assessment.
- Marketed drugs with a new safety signal or a new indication.
- Clinical trials.
Attached Files
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GUIDELINES ON BENEFIT-RISK ASSESSMENT OF HEALTH PRODUCTS AND TECHNOLOGIES.pdf | Download |