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
-
Federal Court of Appeal dismisses appeal of SPRAVATO “innovative drug” decision
On November 10, 2021, the Minister of Health refused to reassess its decision that Janssen’s esketamine hydrochloride product (SPRAVATO) was not an “innovative drug” and therefore not entitled to data...Read More -
CIPO will not issue patents on July 9 or July 16
The Canadian Intellectual Property Office (CIPO) will be launching a new online portal for patent services, MyCIPO Patents, on July 15, 2024.Read More -
2024 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2024, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories ...Read More