ARCHIVED Interim Order No. 2 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 3, 2021

On May 3, 2021, the Minister of Health approved Interim Order No. 2 Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. Interim Order (IO) No. 2 replaces IO No. 1. The first interim order was signed on May 23, 2020, as a response to the ongoing need for urgent COVID-19 diagnosis, treatment, mitigation or prevention options.

IO No. 2 continues to support the optional pathway introduced by IO No. 1 to facilitate clinical trials for potential COVID-19 drugs and medical devices. It also continues to uphold strong patient safety requirements and validity of trial data. IO No. 2 does not apply to radiopharmaceutical drugs, natural health products and Class I medical devices.

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Why a new interim order was issued

Health Canada has authorized a few therapies and vaccines to treat or prevent COVID-19. However, there continues to be a need to study and investigate therapeutic products through clinical trials to protect the health and safety of Canadians and meet an urgent public health need. Clinical trials are an important step in finding safe and effective treatment options for patients.

IO No. 1 is also set to expire on May 23, 2021. (Interim orders have a maximum duration of 1 year from the date they are made.)

We need to ensure that any authorizations or submissions under IO No. 1 continue past the expiration date.

IO No. 2 maintains the optional pathway introduced under IO No. 1 for any new COVID-19 drug and device clinical trials.

What's new in IO No. 2

New transitional provisions will address:

This is to ensure there's no interruption in the authorizations, obligations and oversight made possible by IO No. 1.

This means that:

Minor technical fixes have also been made to:

Facilitating COVID-19 clinical trials in Canada

IO No. 2 continues to offer 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.

IO No. 2 will help to:

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

IO No. 2 continues to reinforce 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 IO No. 2, we will continue to review clinical trials applications (and amendments) for COVID-19-related 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 No. 2 pathway is an alternate pathway 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 use this pathway.

Contact us

If you wish to submit an application for authorization of a clinical trial under IO No. 2, please contact Health Canada. You can also refer to the guidance documents for COVID-19 drug clinical trials or for COVID-19 medical device clinical trials.

Please contact us at:

Related links and guidance

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