Health Canada

Learn about food safety during the coronavirus disease (COVID-19) pandemic and how to keep you and your family safe.

COVID-19 is a new disease not previously identified in humans. Health Canada is closely tracking all potential drugs and vaccines in development in Canada and abroad. Learn more about drugs and vaccines being developed or authorized for COVID-19. This list will be updated weekly.

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.

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...

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.

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). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

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 COVID-19 vaccines as much as possible.

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

Good manufacturing practices (GMP) ensure that drugs meet the quality standards appropriate to their intended use before they are sold.

Briefing packages prepared for the purpose of enabling a new Minister or Deputy Minister to assume their new responsibilities, Overview of the Health Portfolio and its five organizations, Covid overview, First 100 days, Pocket book with Health Portfolio highlights,

This report presents evidence-informed recommendations for testing a vaccinated population and vaccinated individuals.

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.

Learn more about drugs and vaccines being developed or authorized for COVID-19.

When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the...

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

Health Canada has updated the product information for the Pfizer-BioNTech COVID-19 vaccine to describe very rare reports of Bell’s Palsy (typically temporary weakness or paralysis on one side of the face) following vaccination.