Guidance on applications for COVID-19 drug clinical trials under the Regulations: Overview

This guidance document supports the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), which provides an optional pathway for applicants applying to conduct COVID-19 clinical trials.

The document provides guidance to:

applicants seeking authorization to conduct COVID-19 drug clinical trials under the Regulations, instead of the Food and Drug Regulations
authorization holders of COVID-19 drug clinical trials who held an authorization that was granted under the Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19 (IO No. 1) or the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19 (IO No. 2)

Scope and application

Applicants of COVID-19 drug clinical trials may apply for authorization under the Regulations or under Part C, Division 5 of the Food and Drug Regulations (FDR). Those authorized under the Regulations are exempt from Division 5 and other provisions of the FDR, except where described in the Regulations and subject to certain modified requirements. These include the following:

life-cycle authorization of the clinical trial and sale or import of the drug, which allows for more flexible authorization of the trial itself, including through terms and conditions, and reduced reporting requirements
reduced requirements for trials involving already marketed drugs for new uses for the COVID-19 pandemic, while maintaining patient safety protections
flexibility to use a broader range of qualified investigators, obtain informed consent in new ways and run more decentralized trials

The Regulations also ensure that existing authorizations, suspensions and exemptions for clinical trials issued under IO No. 2 remain in effect. This includes any terms and conditions. As well, any applications that were outstanding when IO No. 2 was repealed are deemed to be applications made under the Regulations.

Trials already under way (filed under Part C, Division 5) or new trials filed under Part C, Division 5 and not authorized under IO No. 2 cannot be transitioned under the Regulations. This was the case under IO No. 2. Authorization holders continue to hold their existing authorizations under the regulatory framework for which they were approved.

The Regulations apply to COVID-19 drug and medical device clinical trials, which are expected to be the predominant therapies related to COVID-19. For guidance on COVID-19 trials using medical devices, consult the following guidance document:

Applications for COVID-19 medical device clinical trials under the Regulations

COVID-19 drugs include pharmaceutical drugs and biologic drugs (including vaccines, blood and blood components) that are the subject of a clinical trial. Clinical trials for radiopharmaceuticals (Schedule C of the Food and Drugs Act) and natural health products are not subject to the Regulations. Division 5 of the FDR and associated guidance continue to apply for all non-COVID-19-related drug clinical trials and those that are not covered in the Regulations.

Policy objectives

The Regulations continue to facilitate clinical trials to investigate and offer potential drugs that may diagnose, treat, mitigate or prevent COVID-19. The Regulations also continue to uphold strong participant safety precautions and validity of trial results.

Policy statements

Health Canada is committed to continue prioritizing the review of clinical trial applications that investigate the diagnosis, treatment, mitigation or prevention of COVID-19.

The Regulations enable efficiencies to help further facilitate the conduct of COVID-19 clinical trials for both new drugs and repurposed marketed drugs.

Clinical trial authorization holders must conduct COVID-19 clinical trials according to high ethical research standards and ensure the safety of participants.

As such, many requirements from Division 5 of the FDR that protect trial participants and those who help ensure the reliability of results are duplicated in the Regulations.

To facilitate use of this pathway, existing guidance is referenced and the process for submitting applications, amending and providing additional information is maintained.

Where possible and where proper procedures are in place to monitor such activities remotely from the site, clinical trial activities may include virtual recruitment, informed consent, monitoring and/or visits.

For other considerations when conducting a COVID-19 clinical trial, please refer to:

Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors

COVID-19 drug clinical trials authorized under the Regulations are subject to compliance and enforcement measures.

Background

COVID-19 is the infectious disease caused by the recently discovered coronavirus, SARS-CoV-2. This new virus and disease were unknown before the outbreak began in December 2019 and have since spread around the world. COVID-19 has been known to cause respiratory symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, COVID-19 infection can cause pneumonia, severe acute respiratory distress, kidney failure and death. Older people and those with underlying medical problems, such as high blood pressure, heart problems or diabetes, are more likely to develop serious illness.

The World Health Organization declared a global pandemic related to COVID-19 on March 11, 2020. Originally seen to be a local outbreak, it has now affected most countries across the globe. The situation continues to evolve and change. As there are a limited number of authorized therapies and vaccines to effectively treat or prevent COVID-19, there continues to be an urgent need to get such therapeutic products into clinical trials. Clinical trials are an important step in finding safe and effective treatment options for patients.

The Regulations and this guidance document have been developed to ensure that drugs for diagnosing, treating, mitigating or preventing COVID-19 can be investigated efficiently within a clinical trial.

Definitions

Unless explicitly listed below or in the Regulations, all phrases in the Regulations have the same meaning as those in Division 5 of the FDR. For a full list of applicable definitions, refer to section 2.1 of:

Guidance document for clinical trial sponsors: Clinical trial applications

Applicant/authorization holder: Has the same meaning as sponsor in Division 5 (an individual, corporate body, institution or organization that conducts a clinical trial) and is the person applying or authorized to conduct the clinical trial.

Clinical trial: A study involving human subjects (participants) for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose.

Clinical trial site: The location where a qualified investigator conducts or monitors clinical trial activities.

COVID-19: The coronavirus disease 2019 (COVID-19).

COVID-19 drug: A drug for human use that is manufactured, sold or represented for use in relation to COVID-19.

COVID-19 drug authorization: An authorization to:

import or sell a COVID-19 drug that is to be tested in a clinical trial
conduct a clinical trial in respect of such a drug

Interim Order No. 2 (IO No. 2): The Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19, made by the Minister on May 3, 2021, and published in the Canada Gazette, Part I, on May 22, 2021. IO No. 2 was repealed on February 26, 2022, and replaced by the Regulations, which came into effect on February 27, 2022.

Qualified investigator: A person who is a member in good standing of a professional association of persons entitled under the laws of a province to provide health care under their licence in that province and who:

conducts the clinical trial or
is the responsible leader of a clinical trial conducted by a team

Research ethics board: A body that is not affiliated with for a COVID-19 medical device or drug authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects (participants) to ensure the protection of their rights, safety and well-being.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied by industry and other applicants. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We must make sure that such requests are justifiable and that decisions are clearly documented.

This document should be read in conjunction with the relevant sections of the Regulations and other applicable guidance documents.

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Date modified:: 2022-03-02

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