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Drugs and vaccines for COVID-19

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Regulatory response to COVID-19

The COVID-19 pandemic has created an unprecedented demand on Canada's health care system and has led to an urgent need for access to health products.

As part of the government's broad response to the pandemic, Health Canada introduced new innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.

These measures are helping to make health products needed for COVID-19, such as investigational drugs and vaccines, available to Canadians and health care workers.

We are also working with our international partners on a coordinated and well-aligned approach to this global pandemic. This ensures that our policies and regulatory approaches are aligned and that health products are safe, effective and quickly available to Canadians. Collaboration also helps advance the development of diagnostics, treatments and vaccines that will save lives and protect the health and safety of people everywhere.

Regulating drugs and vaccines sold in Canada

Drugs, including vaccines, are regulated under the Food and Drugs Act and Regulations. They must meet the regulatory requirements for safety, efficacy and quality before they can be sold in Canada. Health Canada's regulatory process involves:

We have authorized certain products to treat COVID-19 and its symptoms.

On December 9, 2020, we authorized the first vaccine in Canada for the prevention of COVID-19.

Find out about COVID-19 vaccines that are authorized in Canada.

You can search the complete list of drugs and vaccines that have been authorized for treating and preventing COVID-19.

Monitoring SARS-CoV-2 variants

Genetic variations are common in viruses such as the SARS-CoV-2 that causes COVID-19. The federal government is closely monitoring the genetic variants of this virus to assess impacts on the COVID-19 pandemic in Canada. We evaluate new variants in collaboration with international experts to define key characteristics such as severity of disease, transmission, and impacts on vaccine or treatment effectiveness.

Health Canada is monitoring the emerging variants closely. We are working with manufacturers, international regulators, and the World Health Organization to determine if the new variants reduce the effectiveness of approved vaccines and treatments. Health Canada also requires manufacturers to consider the impacts of variants during product development, and evaluate the effectiveness of approved vaccines and therapeutics as new variants emerge. If an issue is identified, Health Canada will work quickly with the manufacturers and public health laboratories to respond and to keep everyone in Canada informed.

We have issued guidance documents for COVID-19 treatments and vaccines. Regulatory tools are in place to support the development and expedited regulatory review of new variant-specific vaccines and treatments if this becomes necessary. Health Canada is also working with international regulators to ensure a clear and consistent approach to vaccines targeting new variants. This approach is outlined in our international variant statements:

Potential drugs and vaccines for COVID-19

There are many potential drugs being investigated in Canada and around the world for use against COVID-19. We are closely tracking all potential drugs and vaccines in development.

Potential COVID-19 drugs currently being investigated in Canadian clinical trials include:

You can search the complete list of applications received for COVID-19-related drugs and vaccines and their status.

Clinical trials for drugs and vaccines

Clinical trials are the most appropriate way for Canadians to access experimental drugs or vaccines that could help treat or prevent COVID-19. During a trial, companies or sponsors collect information on the risks and benefits of a drug or vaccine. Participants must give their informed consent in order to participate.

Sponsors must apply to conduct a clinical trial in Canada. The new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of the Interim Order No. 2.

The Regulations are a temporary measure. They will maintain the flexibilities and pathway set out by the interim order until the framework established through the Clinical Trials Modernization Initiative is in place. By reducing administrative burden, the Regulations will continue to:

In addition to the Regulations, Health Canada is working hard to expedite the authorization of trials for COVID-19. Applications are being reviewed faster than usual to speed up access without compromising patient safety. We are also encouraging companies, academic research centres and investigators who have products in development and pre-clinical data to contact us before they apply so we can advise them on the regulatory process.

See Health Canada's complete list of authorized clinical trials for drugs and vaccines for COVID-19. For a broader list all of authorized clinical trials, including those not related to COVID-19, please visit Health Canada's clinical trials database.

Market authorization

Health Canada reviews scientific evidence of a drug or vaccine, including results from clinical trials, to assess the product's safety, efficacy and quality before it can be sold in Canada. To facilitate earlier access to COVID-19 drugs or vaccines, Health Canada prioritized the review of these products while ensuring there is adequate evidence of safety, efficacy and quality to merit access to Canadians.

On September 16, 2020, the Minister of Health signed an interim order (ISAD IO) that introduced a temporary regulatory pathway. This helped expedite the authorization for COVID-19-related drugs and vaccines without compromising patient safety.

As of October 2020, Health Canada began receiving submissions for approval under the ISAD IO. The data provided in each submission was carefully reviewed to ensure that any new vaccine or treatment made available to Canadians is safe, effective and of high quality.

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.

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.

See Health Canada's complete list of applications received for COVID-19-related drugs and vaccines and their status. See also the complete list of all drugs and vaccines that have been authorized for treating COVID-19.

Special Access Program

The most appropriate way to access unproven treatments is through clinical trials. However, the Special Access Program (SAP) is also available to health care professionals who are treating seriously ill patients where conventional therapies have failed, are unsuitable or are unavailable.

The SAP authorizes a manufacturer to sell a drug on a case-by-case basis for an individual who requires access to a product that cannot otherwise be sold or distributed in Canada. Recently, the regulations for the program were modernized to better facilitate access to drugs for Canadians, including treatments for COVID-19. These regulatory changes will:

To access products under the SAP, health care professionals must ask Health Canada for permission and companies must agree to provide the product. We will review the evidence on the drug's safety and efficacy for use in a medical emergency. We will consider each request separately.

For questions about SAP, please email us at hc.sapd-pasm.sc@canada.ca.

Addressing drug shortages

We are actively monitoring the impact of the COVID-19 pandemic on the supply of drugs in Canada. This includes identifying areas in Canada's supply chain where supply may be vulnerable and addressing those vulnerabilities before shortages develop.

We have also introduced regulatory measures to address drug shortages.

On March 30, 2020, an interim order (IO) to prevent or ease shortages of drugs, medical devices and foods for a special dietary purpose was introduced. Among other things, this IO allows companies with drug establishment licences to import foreign drugs that meet similar high quality and manufacturing standards as Canadian-approved drugs. See the list of drugs for exceptional importation and sale.

As well, on September 18, 2020, the Minister of Health approved an IO on preventing and alleviating drug shortages in relation to COVID-19. This IO provides more tools to urgently address drug shortages related to COVID-19 by authorizing the Minister of Health to:

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