Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document

From Health Canada

Overview

The objective of this guidance document is to assist Market Authorization Holders (MAHs) in developing a post-market benefit-risk assessment for a marketed drug when requested.

Who this guide is for

• Market Authorization Holders (MAH) for marketed drugs in Canada
• Consultants who prepare post market benefit-risk assessments

In this guide

• 1 Introduction
  • 1.1 Objective
  • 1.2 Scope
  • 1.3 Background
    • 1.3.1 Benefit-Risk Assessment as Part of the Health Product Lifecycle
    • 1.3.2 Purpose of a Benefit-Risk Assessment
    • 1.3.3 Regulatory Background
• 2 Preparing a Post-Market Benefit-Risk Assessment
  • 2.1 Background Information
    • 2.1.1 Purpose
    • 2.1.2 Product Information
    • 2.1.3 Regulatory History
    • 2.1.4 Exposure Estimates
    • 2.1.5 Information on the Disease(s) or Condition(s)
    • 2.1.6 Other Therapeutic Options
  • 2.2 Evaluation of Benefit
    • 2.2.1 Characterization of Benefit(s)
    • 2.2.2 Discussion of Comparative Benefits
  • 2.3 Evaluation of Risk
    • 2.3.1 Characterization of the Identified Risk
    • 2.3.2 Considerations of the Issue (Identified Risk)
    • 2.3.3 Discussion of Comparative Risks
  • 2.4 Evaluation of the Benefit-Risk Profile
    • 2.4.1 Summary and Analysis of the Benefit-Risk Profile for the Identified Risk
    • 2.4.2 Quantitative Benefit-Risk Analysis
    • 2.4.3 Benefit-Risk Analysis in Context
  • 2.5 Conclusions and Risk Mitigation Options
    • 2.5.1 Conclusions
    • 2.5.2 Risk Mitigation Options
• 3 For Further Information
• Appendix 1: Sections that may be utilized or re-used from the Periodic Safety Update Report (PSUR) or Periodic Benefit - Risk Evaluation Report (PBRER)
• Appendix 2: Definitions and Abbreviations
• Appendix 3: References

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Details and history

Published: February 8, 2019

Consulted: May 15, 2014

For assistance

Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9
E-mail: hc.mhpd-dpsc.sc@canada.ca
Telephone: 613-954-6522

Our service hours are Monday to Friday from 8 a.m. to 6 p.m. (local time) and closed statuary holidays.