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).
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Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection
The Federal Court found that subsection C.08.004.1(3) of the Food and Drug Regulations applied to prevent the Minister from issuing an NOC in view of the data protection granted to FIRDAPSE, a drug co...Read More -
Consultation open on Health Canada’s proposal on agile licensing for drugs and medical devices
On December 17, 2022, the proposed amendments to both regulations were published for consultation: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing).Read More -
Certificate of Supplementary Protection filing fee increase effective April 1, 2023
On April 1, 2023, the fee for filing a Certificate of Supplementary Protection (CSP) will increase from $9,952 to $10,152 in accordance with subsection 9(1) of the Certificate of Supplementary Protect...Read More