Health Canada

Two of the vaccines approved for use in Canada are messenger RNA vaccines (called mRNA vaccines): Pfizer and Moderna. mRNA vaccines are a new type of vaccine. They don't use live virus to trigger an immune response.

Two of the vaccines approved for use in Canada are viral vector-based vaccines: AstraZeneca and Janssen. These types of vaccines use a harmless virus (in this case, the adenovirus) as a delivery system. This vector virus is not the virus that causes COVID-19. You can't get COVID-19 from the...

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance. This collective statement on COVID-19 vaccines...

This Points to Consider document lays out a regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.

Health Canada developed a licensing approach to produce and distribute alcohol-based hand sanitizers on March 27, 2020 (updated on July 13, 2020) for companies. The guide has useful information on the authorizations required to manufacture, package, label, import and/or distribute alcohol-based...

As outlined in the Quality of Natural Health Products Guide, isopropyl alcohol (IPA) used in the production of hand sanitizers should meet identity and purity criteria.

Companies that use unacceptable quality standards may be subject to enforcement action. Our main goal is to protect the health and safety of the public.

Learn about food safety during the coronavirus disease (COVID-19) pandemic and how to keep you and your family safe.

The Government of Canada is working to respond to challenges raised by the food industry as a result of the COVID-19 pandemic while continuing to ensure that Canadians have access to safe and nutritious food.

Several different types of treatments for COVID-19 have been developed. Examples include drugs that reduce or stop the virus from multiplying in human cells and drugs that treat the symptoms of COVID-19.

Authorizations may be revoked for some medical devices that were authorized under either the: IO No.1 or IO No. 2. It is important for health care professionals and other users to check this list regularly for those products no longer authorized.

In addition to existing medical device databases, there are lists of authorized COVID-19-related medical devices. These lists are a result of regulatory tools in place to expedite access to COVID-19 medical devices. The following information explains what resources to check to determine if a...

Sponsors of COVID-19-related drug and vaccine clinical trials can choose between 2 different processes: existing process outlined in the Food and Drug Regulations or process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19.

The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. Authorization is done through the Medical Device Regulations or the Interim Order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical...

The Minister of Health signed the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 on March 18, 2020. A second Interim Order was introduced on March 1, 2021 and replaced the first one. The Interim Order (IO) expedites the authorization of Class...

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization: process for investigational testing outlined in the Medical Devices Regulations or process outlined in the new interim order for clinical trials for medical...

Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology tests are also known as antibody tests. Serological tests are not appropriate for diagnosing COVID-19. However, Health Canada is authorizing the sale in Canada of...