Open Government Portal
Found 10 records similar to Guidance for market authorization requirements for COVID-19 vaccines: Requirements for vaccines to address SARS-CoV-2 variants
How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program to find therapies to prevent or treat COVID-19.
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.
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.
What you, and what communities can do to lower the spread of COVID-19 in settings including social services, workplaces, outdoors, community, religious, transport and remote and Indigenous communities.
COVID-19 vaccine ingredients in the Pfizer-BioNTech, Moderna and AstraZeneca vaccines.
This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling a COVID-19 vaccine in Canada.
This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.
Currently there are no therapies available for either the prevention or treatment of COVID-19. Health Canada is closely tracking all potential therapeutic treatments and vaccines in development in Canada and abroad, including products that are being used off-label. The Department is working with vaccine developers, researchers, and manufacturers to help expedite the development and availability of medical products such as vaccines, antibodies, and drugs to prevent and treat COVID-19.
This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to market in Canada.
This report presents evidence-informed recommendations for testing a vaccinated population and vaccinated individuals.