On February 8, 2019, Health Canada released the Overview of the format and content for post-market drug benefit-risk assessment in Canada – guidance document. The objective of the Guidance Document is to assist Market Authorization Holders in developing a post-market benefit-risk assessment for a marketed drug when requested.
The purpose of a benefit-risk assessment is to determine whether sufficient evidence exists to demonstrate that the benefits of a product continue to outweigh the risks. A benefit-risk assessment may, for example, be requested voluntarily, or under the authority of section 21.31 of the Food and Drugs Act and section C.01.052 of the Food and Drug Regulations, which were enacted by Vanessa’s Law (see update of our previously published chart here).
Related Publications & Articles
-
Health Canada aims to reduce red tape by increasing international collaboration, alignment and reliance
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth.Read More -
Medical devices updates: new Health Canada guidance for determining medical device application type and Medical Devices Directorate performance reports released
In August 2025, Health Canada released the Guidance for determining medical device application type.Read More -
CDA releases strategy to improve the appropriate prescribing and use of prescription medications in Canada
On September 18, 2025, Canada’s Drug Agency (CDA) launched its new strategy to improve the appropriate prescribing and use of prescription medications in Canada.Read More
