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

Date published: 2021-05-05

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

• has never been approved in Canada
• was previously approved in Canada for another use
• has been approved by a trusted foreign regulatory authority

An applicant can also file a new drug submission 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 4 possible scenarios:

• Pending
• Authorized
• Rejected (by Health Canada)
• Cancelled (by the company)

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.