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

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Pre-clinical trial application consultation

Health Canada encourages applicants of COVID-19 drug clinical trials to request a pre-clinical trial phone or video consultation to discuss the trial before submitting an application. We will prioritize these requests for consultation.

Please refer to the Who to contact section.

Submitting an application

To sell or import a COVID-19 drug for the purpose of conducting a clinical trial, applicants must seek authorization before starting the trial.

The application requirements under section 20 of the Regulations are the same as Division 5 for novel therapies.

To apply for an authorization, must submit a clinical trial application in accordance with the content and format outlined in section 2.3 of:

While the application process is the same, applicants must clearly indicate in their application cover letter that they are applying for authorization under the Regulations. They must also indicate how the drug meets the definition of a COVID-19 drug, including the active role the drug will play in diagnosing, treating, mitigating or preventing COVID-19.

Note: Any applications filed under IO No. 2 that were outstanding when IO No. 2 was repealed will be considered under the Regulations. The Minister may request more information about a COVID-19 clinical trial submission at any time.

Clinical trial involving new uses of a marketed drug

Health Canada recognizes that in the context of the COVID-19 pandemic, clinical trials may be conducted to determine new uses of already marketed drugs.

The Regulations expand on the current policy interpretation to apply similar exemptions to investigational drugs (that is, repurposed drugs for the purpose of COVID-19) if it’s determined that use of the drug aligns with the standard medical practice.

The requirements for marketed drugs apply to drugs marketed in Canada:

For a clinical trial involving marketed drugs where the drug is being used according to standard medical practice but outside its approved indication, the application must include all elements of a standard application package. Exceptions are for:

In place of this information, the applicant must include:

The following supporting evidence may be requested during review of the clinical trial application:

For trials involving such marketed drugs, Health Canada may authorize the application after determining that the drug aligns with standard medical practices (has an established safety profile in that population). If authorized under this provision, the drug will be exempted from the following requirements of the Regulations:

The authorization holder would be required to maintain records on any serious unexpected adverse drug reaction that has occurred inside or outside Canada.

The other requirements laid out in the Regulations and this guidance document continue to apply.

Issuing an authorization

When Health Canada receives a complete application, we will review it to determine that:

If these conditions are met, we will issue a notice of authorization for the importation or sale of the COVID-19 drug to be tested in the clinical trial and for the conduct of the trial under the Regulations. This represents a change from the existing Division 5 of the FDR, which includes a 30-day default authorization.

Under the Regulations, Health Canada will review clinical trial applications and amendments for COVID-19 drug clinical trials within 30 days.

All other aspects of our review process remain the same as under existing guidance, including the screening process and response to clarification requests.

For information on the review process, please refer to section 2.5 of:

An authorization holder must have a representative in Canada who is responsible for the import and sale of the drug in Canada and must be able to demonstrate compliance to the applicable regulatory requirements. This is in line with Division 5 of the FDR and the prohibitions in sections 25 and 26 of the Regulations.

Any authorizations issued by Health Canada under IO No. 2 and not revoked in whole are considered authorized under the Regulations. As such, approval by a research ethics board that was received under IO No. 2 is deemed to be an approval under the Regulations.

Additional information before commencing a clinical trial

Before a COVID-19 drug can be imported or sold and before a clinical trial can begin, the authorization holder must have obtained approval from the research ethics board for each clinical trial site. The following information is required:

These requirements are the same as those in Division 5 of the FDR.

To submit this information to Health Canada, use the form and follow the order laid out in section 2.7 of:

The differences in the Regulations and Division 5 of the FDR are the definitions of qualified investigator and the means of obtaining informed consent. These have been expanded to enable greater flexibility while maintaining high ethical standards.

Terms and conditions

Health Canada may, at any time, impose or amend terms and conditions on the COVID-19 drug clinical trial authorization. This authority allows for flexibility in allowing a trial to proceed while attaching additional conditions and/or limitations on the authorization. These terms and conditions are used to ensure appropriate oversight, manage uncertainties or mitigate risks.

For example, we may require that the authorization holder submit results of the first phase of a phase I/II study or that a safety summary be submitted at a specified time.

Note: Any terms and conditions that were imposed under IO No. 2 will remain in effect under the Regulations.

Submitting/fulfilling terms and conditions

Information on the fulfilment of terms and conditions that fall outside the amendment process should be submitted in the form of a notification. This should be titled “Fulfilling Terms and Conditions – Notification.” Include a cover letter and any supporting documentation.

Health Canada will review the notification and documentation to determine if the conditions have been met. When we are satisfied that the terms and conditions of the authorization have been met, we will issue a letter indicating this to the authorization holder.

Submitting an amendment to a clinical trial authorization

Before implementing significant changes to the originally submitted protocol (paragraph 20(2)(a)) or chemistry and manufacturing information for the drug being studied, authorization holders must submit these for authorization (paragraph 20(2)(m)).

The process for filing an amendment to a clinical trial application under the Regulations is the same as filing an amendment under Division 5 of the FDR.

For information on how to file an amendment and examples of protocol changes that require an amendment, refer to section 2.4.1 of:

Note: Any applications to amend an authorization that were outstanding when IO No. 2 was repealed are considered under the Regulations.

Changes not requiring an amendment or notification

The existing post-authorization change notification scheme under Division 5 of the FDR does not apply to COVID-19 drug clinical trials under the Regulations. Amendments to applications that do not meet the criteria noted above can be implemented without submitting a notification to Health Canada.

Authorization holders should keep records of such changes on file.

Immediate changes/application to amend

If the clinical trial or use of the drug that is being tested endangers trial participants or others, an authorization holder may make an immediate amendment without prior review by Health Canada.

The authorization holder must notify us of the change and submit an amendment to a clinical trial application within 30 calendar days after the amendment was implemented.

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