ARCHIVED Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice

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.

On this page

• Why a new interim order was issued
• What's new in IO No. 2
• Facilitating COVID-19 clinical trials in Canada
• Prioritizing COVID-19 clinical trials
• Contact us

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:

• any clinical trial submissions that are outstanding when IO No. 1 expires or
• authorizations for drugs and devices issued under IO No. 1

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

This means that:

• all applications, authorizations, suspensions, revocations and requests made under IO No. 1 are deemed to be made under IO No. 2
• all requirements and obligations imposed under IO No. 1 are deemed to be requirements and obligations under IO No. 2
• requests by the Minister for information or materials under IO No. 1 are deemed to be requests under IO No. 2

Minor technical fixes have also been made to:

• address the French and English discrepancies in subsections 15(2) and 15(3) of IO No. 1 and
• clarify provision 28(h) of IO No. 1 on informed consent

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:

• reduce administrative requirements for assessing the use of existing marketed drugs as possible COVID-19-related therapies
• allow alternate means of obtaining patient consent in light of COVID-19 realities
• broaden the criteria for qualified health professionals who can carry out qualified investigator duties at remote sites for drug clinical trials
• expand the range of applicants who are able to apply for a medical device clinical trial authorization

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:

• trials using pharmaceutical drugs: hc.oct.enquiries-requetes.bec.sc@hc-sc.gc.ca
• trials using biologic drugs (including blood and blood components): brdd.ora@hc-sc.gc.ca
• trials using medical devices: it-ee@hc-sc.gc.ca

Related links and guidance

• Applications for COVID-19 drug and medical device clinical trials under the interim order: Notice of updated guidance documents
• Guidance document for clinical trial sponsors: Clinical trial applications
• Applications for medical device investigational testing authorizations - guidance document
• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
• Clinical trials in Canada
• Health Canada's clinical trials database
• Drugs and vaccines for COVID-19: List of all COVID 19 clinical trials authorized by Health Canada
• Medical devices for COVID-19: List of authorized clinical trials