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 is prioritizing the review of these products. The interim order pathway for COVID-19-related drugs and vaccines (ISAD IO) was signed by the Minister of Health to address the COVID-19 emergency and came into effect on September 16, 2020.

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 ISAD IO was valid for 1 year and 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 as well as to provide permanent legal status, we introduced amendments 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.

The amendments maintain many of the agile measures introduced through the ISAD IO thus continuing to provide Canadians with quick access to safe and effective COVID-19 drugs.

The amended Regulations offer the following benefits:

Health Canada only grants a Notice of Compliance (NOC) for a COVID-19 drug under the Regulations if it's determined that the benefits outweigh the risks. Any uncertainties or risk mitigation measures related to the drug in the context of the public health need due to COVID-19 are managed through terms and conditions.

As with all drugs, Health Canada assesses and monitors the safety and effectiveness of all COVID-19 drugs for which an NOC is issued. If required, Health Canada takes immediate action, including compliance and enforcement measures and the suspension or cancellation of an authorization, to protect the health and safety of Canadians.

Information for applicants

The Guidance on modified requirements for drugs for use in relation to COVID-19 will help manufacturers prepare a submission to seek authorization for a COVID-19 drug under the Regulations. It also 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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