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Found 10 records similar to Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Post-market requirements

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
Federal

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.

Last Updated: Jul. 27, 2021
Date Published: Mar. 30, 2021
Organization: Health Canada
Formats: HTML
Keywords:  coronavirus, COVID-19, pandemic, drugs, medications, vaccines, market authorization, licensing, importing or selling
Federal

A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as “pre-positioning.” It facilitates the immediate distribution of the drug upon authorization, making it available to Canadians as early as possible.

Last Updated: Jul. 29, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, COVID-19 drug, amendement, Food and Drug Regulations, drugs, manufacturers, submission, notice of compliance
Federal

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.

Last Updated: Aug. 31, 2021
Date Published: Jul. 14, 2021
Organization: Public Health Agency of Canada
Formats: HTML
Keywords:  COVID-19, Vaccine safety, post-market surveillance, surveillance, vaccines, vaccine safety, COVID-19 vaccine, vaccine effectiveness, Community immunity
Federal

List of priority drugs currently having quantities placed in reserve to manage drug shortages for the treatment of COVID-19.

Last Updated: Apr. 30, 2021
Date Published: Mar. 3, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, priority drugs, critical drug, reserve, drug shortages for the treatmentof COVID-19
Federal

A product monograph is a factual, scientific document on a drug product. It does not contain promotional material. The monograph describes the properties, claims, indications and conditions of use for the drug. It also contains any other information that may be required for optimal, safe and effective use of the drug.

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, labelling requirements, post-market requirements
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

This interim order (IO) provides more tools for urgently addressing drug shortages related to COVID-19.

Last Updated: Apr. 30, 2021
Date Published: Oct. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, Interim Order, prevention and alleviation of shortages of drugs, drug shortages related to COVID-19
Federal

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Last Updated: Jul. 27, 2021
Date Published: Jun. 14, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, vaccines for COVID-19, drugs for COVID-19, list of authorized clinical trials
Federal

This document provides guidance on brand name assessment, inner and outer product labels, and risk management planning.

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, labelling requirements, post-market requirements
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