Conducting a COVID-19 drug and vaccine clinical trial

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Clinical trial regulations

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

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:

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:

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

The drug or vaccine in question must be:

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

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.

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