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Found 10 records similar to Guidance for market authorization requirements for COVID-19 drugs: Labelling and post-market requirements
This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.
The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not required, sponsors are invited to provide a brand name assessment should one be available.
We are collaborating with other national regulatory authorities to align the requirements for evaluating, authorizing and post-market surveillance of variant COVID-19 vaccines as much as possible.
Canada has several systems in place to monitor the safety and effectiveness of vaccines starting in the early development stage and continuing for as long as the vaccines are in use. Get the facts. Visit Canada.ca/covid-vaccine to learn more.
This document provides guidance to vaccine manufacturers seeking authorization for their vaccine that targets the SARS-CoV-2 virus. This guidance applies to applications under the interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.
This document provides guidance to drug manufacturers seeking authorization for their drug manufactured, sold, or represented for use in relation to COVID-19. The guidance explains recent changes to the regulatory process for new COVID-19 drugs.
COVID-19 drugs must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with the international requirements outlined in the International Council for Harmonization Q7A guideline and with applicable Health Canada's guidance.
This document provides guidance on the standard for accepting a rolling submission and non-clinincal requirements for authorization.
This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to market in Canada.
Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.