ARCHIVED Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19: Notice

Notice to Reader:

We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Date published: May 27, 2020

On May 23, 2020, the Minister of Health approved an Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. This Interim Order (IO) is a response to the need for urgent COVID-19 diagnosis, treatment, mitigation or prevention options.

The IO introduces an alternate pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements and validity of trial data. The IO does not apply to radiopharmaceutical drugs, natural health products and Class I medical devices.

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Why the Interim Order was introduced

To date, there are no therapies or vaccines to effectively treat or prevent COVID-19. For this reason, there is an urgent need to initiate clinical trials for novel therapies and to assess the effectiveness of existing therapies. Clinical trials are an important step in finding safe and effective treatment options for patients.

Facilitating COVID-19 clinical trials in Canada

The IO introduces regulatory flexibility to allow for broader types of COVID-19 clinical trials to take place more efficiently. This flexibility also facilitates broader patient participation across the country. The IO will help to:

These key measures will help to identify safe and effective interventions to address the COVID-19 pandemic. They also ensure the safety of clinical trial participants and the reliability of trial results.

The IO reinforces Canada’s status as an attractive place to conduct clinical research, leading to greater access to potential COVID-19 treatment options for Canadians.

Prioritizing COVID-19 clinical trials

Health Canada has already authorized numerous COVID-19 clinical trials under existing regulations. We are committed to prioritizing the review of all COVID-19 clinical trial applications. Under the IO, we will continue to review clinical trials applications (and amendments) for COVID-19 drugs and medical devices within 14 days. Research Ethics Boards across the country are also prioritizing reviews and approvals for COVID-19 clinical trials.

The IO pathway is in addition to the existing regulatory pathways in the Food and Drug Regulations and Medical Devices Regulations. As an alternative to these requirements, the applicants of clinical trials for COVID-19-related drugs and medical devices may choose to proceed through this pathway.

If you wish to submit an application for authorization of a clinical trial under the IO, please contact Health Canada. You can also refer to the guidance document for COVID-19 drug clinical trials or for COVID-19 medical device clinical trials.

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