ARCHIVED Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents

Date published: May 27, 2020

Health Canada has developed 2 guidance documents to support the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. In accordance with subsection 30.1(1) of the Food and Drugs Act:

• For drugs: Applications for drug clinical trials under this Interim Order
• For medical devices: Applications for medical device clinical trials under this Interim Order

On this page

• Purpose
• Interim Order implications for applicants
• Scope
• Implementation

Purpose

The guidance documents contain information for applicants seeking authorization to conduct COVID-19 drug and medical device clinical trials under the new Interim Order (IO). The IO ensures that drugs and medical devices for the diagnosis, treatment, mitigation or prevention of COVID-19 can be investigated efficiently within a clinical trial.

Interim Order implications for applicants

The IO will facilitate the launch of COVID-19-related clinical trials. It reduces administrative burden related to authorization and implementation, while ensuring the health and safety of participants and the validity of trial data.

As the IO covers both drugs and medical devices, it uses the common term “clinical trials” rather than the Medical Devices Regulations term “investigational testing.”

An authorization obtained under the IO covers the sale or importation of a drug or a medical device for the purpose of the trial, as well as the clinical trial itself. This allows flexible oversight through all stages of a trial, to more appropriately authorize and oversee a broader range of trials such as virtual trials.

The health and safety of participants in clinical trials is most important. The IO provides Health Canada with flexibilities to oversee and intervene in clinical trials when required to safeguard the best interests of clinical trial participants.

Flexibility to intervene includes being able to partially suspend or revoke a trial. This will allow the suspension of one arm, or treatment group, of a randomized trial, if needed. The rest of the trial would be allowed to proceed so that other participants can continue to receive a prospective therapy.

Health Canada will be able to use terms and conditions on clinical trial authorizations. These measures will only be used to ensure appropriate oversight or to manage uncertainties or risks. This flexibility may result in the authorization of a broader range of clinical trials that would otherwise not proceed.

The IO reduces the administrative requirements for non-significant changes throughout the trial, with only significant changes requiring approval.

The IO also:

• permits the use of a broader range of qualified investigators
• provides other ways to obtain informed consent
• reduces administrative requirements for trials involving new uses for existing marketed drugs and medical devices

All these flexibilities will be particularly beneficial for complex trials, such as:

• multi-site trials
• multi-arm trials
• remote trials
• trials for repurposing marketed drugs or medical devices for COVID-19 uses

All other requirements for applicants continue to apply. These include requirements related to the submission of applications and reporting of trial-related adverse events or medical device incidents to Health Canada. Applicants will also be obligated to ensure their clinical trial is conducted in accordance with good clinical practices.

Scope

The guidance documents apply to COVID-19 clinical trials for pharmaceutical and biologic drugs (including blood and blood components) and medical devices, including combination products. Clinical trials are for phases I through III of medical device development.

Not included in this IO are radiopharmaceuticals (see schedule C of the Food and Drugs Act), natural health products, Class I medical devices and phase IV clinical trials.

The existing regulations and guidance for all non-COVID-19-related clinical trials and those that are not in scope would continue to apply.

Implementation

The guidance documents will be in effect for a period of 1 year from the date of posting.

Applicants of COVID-19 drug and medical device clinical trials can apply for authorization under either:

• the IO
• Part C, Division 5 of the Food and Drug Regulations or
• Part 3 of the Medical Devices Regulations

Once applicants apply for authorization under the IO, however, they must proceed with the new pathway.

Trials already started cannot be transitioned under the IO and must follow the requirements of the regulations under which they were originally submitted.

If you wish to submit an application for authorization of a clinical trial under the IO, please contact Health Canada. Alternatively, you may refer to the relevant guidance document for COVID-19 drug clinical trials or 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

• Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19: Notice
• Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
• Applications for drug clinical trials under the Interim Order: Guidance Document
• Applications for medical device clinical trials under the Interim Order: Guidance Document
• 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