Drug and vaccine authorizations for COVID-19: Overview

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About market authorization

Health Canada evaluates drugs and vaccines before they can be sold in Canada. We also monitor real-world evidence while they are on the market.

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 potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in Canada only if the benefits of the product outweigh the potential risks.

Prioritizing COVID-19 applications and being transparent

We are committed to prioritizing the review of all COVID-19 drug and vaccine applications without compromising on the assessment of their safety, efficacy and quality. This will facilitate timely access to novel drugs and vaccines.

You can access:

We also publicly make available the safety and efficacy data relied upon to issue market authorization of drugs and vaccines in relation to COVID-19. This clinical information will:

Authorization pathways for COVID-19 drugs and vaccines

To facilitate earlier access to COVID-19 drugs or vaccines, Health Canada prioritized the review of these products. We introduced 2 different authorization pathways for COVID-19-related drugs and vaccines:

An interim order is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.

The ISAD IO facilitated timely access for Canadians to drugs and vaccines that have demonstrated the ability to diagnose, prevent, treat or cure COVID-19. It introduced temporary regulations to expedite the authorization for importing, selling and advertising COVID-19-related drugs without compromising patient safety.

The new tools allowed the Minister of Health to:

  1. authorize a drug that is not yet licensed in Canada or elsewhere with a modified set of requirements
  2. enable applicants to submit an application for one of these drugs with fewer application requirements, based on the authorization of a trusted foreign regulatory authority
  3. expand the use of an already authorized drug to include a COVID-19 indication based on known evidence with or without an application from the market authorization holder

The ISAD IO expired on September 16, 2021. To ensure that COVID-19-related drugs authorized under the ISAD IO may continue to be imported and sold in Canada, we introduced transition measures  to amend the Food and Drug Regulations. The amendments ensure that the review, authorization and oversight of COVID-19 drugs, including new drugs, can now be conducted under the Regulations.

Information for applicants

The ISAD IO provided flexibility in the level of evidence required in an application. Applicants submit the information they have about the drug's quality, safety and effectiveness. The interim order allowed for submissions to be filed on a rolling basis. If the applicant did not have all the required information at the time of initial filing, they were to:

The ISAD IO introduced an option for establishment licences to be issued in relation to COVID-19 drugs with certain flexibilities, taking into consideration the urgent public health need. It also modified certain good manufacturing practice requirements, which provides the necessary flexibility to meet the urgent public health need.
All other requirements for applicants related to the following continue to apply:

There were no fees for the review of an application under the interim order. While it was in force, there was also no annual right-to-sell fee for drugs authorized under the ISAD IO.

As well, we are remitting fees for qualifying DEL applications.

The Guidance on modified requirements for drugs for use in relation to COVID-19 outlines the process for meeting the post-regulatory requirements for COVID-19 drugs.

Contact us

If you wish to apply for authorization of a COVID-19 drug, please review the Guidance on modified requirements for drugs for use in relation to COVID-19 to get more information on the application process and requirements. Then contact Health Canada at:

Applicants are requested to use the Drug Submission Application Form for the authorization of a COVID-19 drug:

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