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Found 10 records similar to Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements

Federal

This document provides guidance on the standard for accepting a rolling submission and non-clinincal requirements for authorization.

Last Updated: Jul. 28, 2022
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, rolling submissions, non-clinical-and-clinical requirements
Federal

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.

Last Updated: Jul. 28, 2022
Date Published: Mar. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, requirements for vaccines, SARS-CoV-2 variants
Federal

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.

Last Updated: Jul. 27, 2021
Date Published: Mar. 26, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

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.

Last Updated: Jul. 28, 2022
Date Published: Nov. 18, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, importation, sale and advertising
Federal

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.

Last Updated: Jul. 27, 2021
Date Published: Apr. 6, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

This document provides guidance on establishment licensing, product quality and lot release to bring a COVID-19 vaccine to market in Canada.

Last Updated: Jul. 28, 2022
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, SARS-CoV-2 virus, COVID-19 vaccines, COVID-19 drugs, market authorization requirements, vaccine manufacturers, establishment licensing, product quality
Federal

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.

Last Updated: Sep. 24, 2021
Date Published: Jun. 12, 2020
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  Coronavirus, COVID-19, pandemic, measures, to reduce, COVID-19, COVID
Federal

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.

Last Updated: Jul. 28, 2022
Date Published: Oct. 29, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, COVID-19 drugs, market authorization requirements, drug manufactured, sold, regulatory process
Federal

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices.

Last Updated: Jul. 24, 2020
Date Published: Apr. 2, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Coronavirus, COVID-19, pandemic, clinical trial for COVID-19 medical devices, authorized clinical trials
Federal

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.

Last Updated: Jul. 27, 2021
Date Published: May 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, vaccines for COVID-19, drugs for COVID-19
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