Drug and vaccine authorizations for COVID-19: Overview
On this page
- About market authorization
- Prioritizing COVID-19 applications and being transparent
- Authorization pathways for COVID-19 drugs and vaccines
- Information for applicants
- Contact us
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:
- a list of applications received for COVID-19-related drugs and vaccines, and their status
- the drugs and vaccines that have been authorized for treating COVID-19
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:
- be released for non-commercial purposes
- have all personal information and confidential business information protected before publication
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:
- continues to support access to safe, effective and high-quality COVID-19 drugs
- enables the sale and advertising of COVID-19 drugs that were authorized under the IO to continue after the IO expires
- enables manufacturers of new COVID-19 drugs for which an authorization was not sought under the ISAD IO to seek authorization under the Regulations with similar requirements as those provided under the ISAD IO
- continues the post-market regulatory obligations placed on authorization holders, manufacturers and importers after the ISAD IO expires
- continues to allow the early importation and placement in Canadian facilities (pre-positioning) of a promising COVID-19 drug for which a federal government contract for its procurement is in place, before that drug receives market authorization in Canada
- continues an agile approach for drug establishment licences (DELs) that authorizes regulated activities for COVID-19 drugs
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.
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:
- pharmaceutical drugs: firstname.lastname@example.org
- biologic drugs: email@example.com
- veterinary drugs: firstname.lastname@example.org
Applicants are requested to use the Drug Submission Application Form for the authorization of a COVID-19 drug:
- Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation
- Health product highlights 2021: Helping you maintain and improve your health
- Guidance for market authorization requirements for COVID-19 drugs
- Mid-year update: Health products approved in 2021
- Drug and medical device highlights 2020: Helping you maintain and improve your health
- Vaccines and treatments for COVID-19: Progress
- Update on remdesivir: continued monitoring
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Guidance for market authorization requirements for COVID-19 vaccines
- Health Canada's special access programs
- Notice to stakeholders: Final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs
- Information and application requirements for drugs authorized under the Interim Order: Guidance document
- COVID-19 health professionals
- Regulating vaccines for human use in Canada
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
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