Drug and vaccine authorizations for COVID-19: List of applications received

Date published: 2021-09-16

Under the interim order, a company could submit an application for a drug or vaccine for use in COVID-19 that:

• ha d never been approved in Canada
• had previously been approved in Canada for another use
• ha d been approved by a trusted foreign regulatory authority

The Interim order expired September 16, 2021 so all new submissions will now be filed under the Food and Drug Regulations.

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.

Information for each application includes the:

• applicant (name of the company that submitted the application)
• medicinal ingredient(s)
• therapeutic area (using the World Health Organization's coding system)
• date we received the application
• outcome of the application
• date of outcome ("not applicable" means the application is still in progress)

In the "outcome of application" column, there are 5 possible scenarios:

• Under review
• Authorized
• Expired (by expiry of interim order)
• Rejected (by Health Canada)
• Cancelled (by the company)

The authorization dates below refer to decisions made under the interim order (IO) or the Food and Drug Regulations (FDR). Authorization of new uses (for example, pediatric use) and their authorization dates are also included.

Consult the Drug and health product submissions under review (SUR) list and the Generic submissions under review list to access submissions under review that are not related to the COVID-19 pandemic.