Drug and vaccine authorizations for COVID-19: Overview
On this page
- About market authorization
- Prioritizing COVID-19 applications and being transparent
- Authorization pathways for COVID-19 drugs and vaccines
- Information for applicants
- Contact us
About market authorization
Health Canada evaluates drugs and vaccines before they can be sold in Canada. We also monitor real-world evidence while they are on the market.
When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality.
Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in Canada only if the benefits of the product outweigh the potential risks.
Prioritizing COVID-19 applications and being transparent
We are committed to prioritizing the review of all COVID-19 drug and vaccine applications without compromising on the assessment of their safety, efficacy and quality. This will facilitate timely access to novel drugs and vaccines.
You can access:
- a list of applications received for COVID-19-related drugs and vaccines, and their status
- the drugs and vaccines that have been authorized for treating COVID-19
We also publicly make available the safety and efficacy data relied upon to issue market authorization of drugs and vaccines in relation to COVID-19. This clinical information will:
- be released for non-commercial purposes
- have all personal information and confidential business information protected before publication
Authorization pathways for COVID-19 drugs and vaccines
Companies can choose between 2 different authorization pathways for COVID-19-related drugs and vaccines:
- existing regulatory pathways outlined in the Food and Drug Regulations or
- the interim order pathway for COVID-19-related drugs and vaccines, which was signed by the Minister of Health and came into effect on September 16, 2020
An interim order is one of the fastest mechanisms available to the federal government for putting in place temporary regulations to help make health products available to address large-scale public health emergencies.
This interim order facilitates timely access for Canadians to drugs and vaccines that have demonstrated the ability to diagnose, prevent, treat or cure COVID-19. The interim order introduces temporary regulations to expedite the authorization for importing, selling and advertising COVID-19-related drugs without compromising patient safety.
The new tools allow the Minister of Health to:
- authorize a drug that is not yet licensed in Canada or elsewhere with a modified set of requirements
- enable applicants to submit an application for one of these drugs with fewer application requirements, based on the authorization of a trusted foreign regulatory authority
- expand the use of an already authorized drug to include a COVID-19 indication based on known evidence with or without an application from the market authorization holder
The interim order is in effect until September 16, 2021. We have introduced transition measures to ensure that COVID-19-related drugs authorized under the IO may continue to be imported and sold in Canada. These measures have been published in the Canada Gazette, Part II.
As of March 18, 2021, the review, authorization and oversight of COVID-19 drugs, including new drugs, can be conducted under the Food and Drug Regulations. Please refer to the Guidance on modified requirements for drugs for use in relation to COVID-19.
Information for applicants
Before making an application under this interim order, companies should review the IO to import, sell and advertise drugs during COVID-19 guidance document to get more information on the application process and requirements.
The interim order provides flexibility in the level of evidence required in an application. Applicants submit the information they have about the drug's quality, safety and effectiveness. The interim order allows for submissions to be filed on a rolling basis. If the applicant does not have all the required information at the time of initial filing, they:
- must submit a plan outlining how and when they will provide the rest of the information; and
- may file information as it becomes available throughout the review process
The interim order introduces an option for establishment licences to be issued in relation to COVID-19 drugs with certain flexibilities, taking into consideration the urgent public health need. It also modifies certain good manufacturing practice requirements, which provides the necessary flexibility to meet the urgent public health need.
All other requirements for applicants related to the following continue to apply:
- advertising claims and other restrictions
- reporting adverse drug reactions
- reporting shortages
There are no fees for the review of an application under the interim order. While it is in force, there will also be no annual right-to-sell fee for drugs authorized under the interim order.
As well, we will remit fees for qualifying DEL applications.
A transition pathway will be put in place before the interim order has expired so that authorizations issued under it can continue. This will consist of measures to enable products authorized under the interim order to seek approvals under the Food and Drug Regulations.
If you wish to apply for authorization of a COVID-19 drug, please review the drug guidance document to get more information on the application process and requirements. Then contact Health Canada at:
- pharmaceutical drugs: email@example.com
- biologic drugs: firstname.lastname@example.org
- veterinary drugs: email@example.com
Applicants are requested to use the Drug Submission Application Form for the authorization of a COVID-19 drug under the IO:
- Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation
- Vaccines and treatments for COVID-19: Progress
- Update on remdesivir: continued monitoring
- Notice for industry: Ensuring predictability for interim orders relating to COVID-19
- Guidance for market authorization requirements for COVID-19 vaccines
- Health Canada's special access programs
- Notice to stakeholders: Final guidance document for industry and practitioners on the Special Access Program (SAP) for drugs
- Information and application requirements for drugs authorized under the Interim Order: Guidance document
- COVID-19 health professionals
- Regulating vaccines for human use in Canada
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
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