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:

There are currently no vaccines authorized for COVID-19. Certain authorized products may ease COVID-19 symptoms, such as fever and cough.

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:

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. On May 23, 2020, the Minister of Health signed the interim order for clinical trials for medical devices and drugs related to COVID-19. The interim order responds to the urgent need for COVID-19 diagnosis, treatment, mitigation or prevention options. It introduces a new pathway to facilitate the conduct of clinical trials in Canada to investigate and offer patient access to potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements.

In addition to the interim order, 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 is prioritizing 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 that introduces a temporary regulatory pathway. This will help 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 drug authorization Interim Order for COVID-19. Health Canada will carefully review all of the data provided. Before any new vaccine or treatment is made available to Canadians, it must be shown to be safe, effective and of high quality.

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.

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