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 prioritized the review of these products. We introduced 2 different authorization pathways for COVID-19-related drugs and vaccines:
- existing regulatory pathways outlined in the Food and Drug Regulations or
- the interim order pathway for COVID-19-related drugs and vaccines (ISAD IO), which was signed by the Minister of Health 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 new tools allowed the Minister of Health to:
- authorize a drug that is not yet licensed in Canada or elsewhere with a modified set of requirements
- 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
- 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:
- submit a plan outlining how and when they will provide the rest of the information and
- file information as it becomes available throughout the review process
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:
- advertising claims and other restrictions
- reporting adverse drug reactions
- reporting shortages
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.
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
- 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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