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).