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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:

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

Attached Files

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GUIDELINES ON BENEFIT-RISK ASSESSMENT OF HEALTH PRODUCTS AND TECHNOLOGIES.pdfDownload

Author

Tony Kemboi

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