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This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation …
A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph …
COVID-19 drugs must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with the international …
Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). …
This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.
This document provides guidance on the standard for accepting a rolling submission and non-clinincal requirements for authorization.
We are collaborating with other national regulatory authorities to align the requirements for evaluating, authorizing and post-market surveillance of variant …
This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to market in …
This final report follows a series of consultations that focused on two key Indigenous Languages Act implementation issues: the establishment …
Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.
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