Conducting a COVID-19 drug and vaccine clinical trial

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• Clinical trial regulations
• Applying to conduct a clinical trial for COVID-19 purposes

Clinical trial regulations

Clinical trials are studies authorized by Health Canada that investigate the safety and efficacy of a drug or vaccine that:

• exists but is to be used for another purpose or
• is not yet available in Canada

Specifically, clinical trials examine the risks and benefits of a drug or vaccine.

Sponsors must apply to conduct a clinical trial in Canada.

For drug and vaccine clinical trials not related to COVID-19, existing regulations and processes still apply.

Applying to conduct a clinical trial for COVID-19 purposes

Health Canada is prioritizing the review of all COVID-19-related clinical trial applications and has already authorized a number of trials.

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 Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

The new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of the Interim Order No. 2.

The Regulations are a temporary measure. They will maintain the flexibilities and pathway set out by the interim order until the framework established through the Clinical Trials Modernization Initiative  is in place. By reducing administrative burden, the Regulations will continue to:

• facilitate the authorization and implementation of COVID-19-related clinical trials
• uphold the health and safety requirements for trial participants and validity of trial data

Sponsors may apply to Health Canada for authorization to conduct a COVID-19 clinical trial.

The drug or vaccine in question must be:

• an existing, marketed product(s) in Canada to be used as COVID-19 treatments or
• new COVID-19 vaccines and treatments currently under development

Before applying, please review the guidance document and guidance document notice. We encourage you to contact Health Canada to request a pre-clinical consultation:

• For enquiries about clinical trials for COVID-19 vaccines and biologic drugs, please contact [email protected].
• For enquiries about clinical trials for COVID-19 pharmaceutical drugs, please contact [email protected].

We are expediting discussions with sponsors that have products in development and sufficient pre-clinical data.

For information on clinical trials for COVID-19 medical devices, please visit our clinical trials for medical devices page.

Related links

• What we heard report on the clinical trials regulatory modernization initiative [2022-02-23]
• What we heard report: Records retention consultations related to the clinical trials interim order transition regulations
• Guidance for market authorization requirements for COVID-19 drugs
• Notice for industry: Ensuring predictability for interim orders relating to COVID-19
• Guidance for market authorization requirements for COVID-19 vaccines
• Management of clinical trials during the COVID-19 pandemic: Notice of clinical trial sponsors
• COVID-19 health products industry
• COVID-19: For health professionals