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:

On May 3, 2021, the Minister of Health signed a second interim order for clinical trials for medical devices and drugs related to COVID-19. The new interim order replaces the original signed on May 23, 2020, and continues to support the optional pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices.

The new interim order continues to streamline the investigation of potential therapies and facilitates broader access for Canadians to COVID-19 related investigational drugs and medical devices. An interim order is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory process.

Under the interim order, Health Canada is reducing the administrative burden for sponsors applying to conduct a COVID-19 clinical trial, while maintaining patient safety and the validity of trial results. It is also introducing flexibility by expanding the types of health care professionals who can conduct a clinical trial. Further information can be found in the interim order notice.

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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