Guidance on amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19: Overview

This guidance applies to sponsors of new COVID-19 drug submissions as well as sponsors seeking a notice of compliance (NOC) for COVID-19 drugs that received temporary authorization under the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO). It also applies to new COVID-19 drug establishment licences under the Food and Drug Regulations.

This document will help manufacturers prepare a submission for a notice of compliance for a COVID-19 drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements.

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Background

The COVID-19 pandemic posed an immediate and significant risk to the health and safety of Canadians. To address the associated public health need in Canada, the Minister of Health made a number of interim orders to expedite and facilitate access to drugs, medical devices and foods for a special dietary purpose. The Minister used the power granted under section 30.1 of the Food and Drugs Act to make these interim orders.

The ISAD IO came into effect on September 16, 2020, and provided:

The ISAD IO ends 1 year after it came into effect. After this time, drugs authorized through the ISAD IO would no longer have been legally permitted to be sold in Canada, unless transition measures were implemented.

The ISAD IO provided a temporary emergency authorization for COVID-19 drugs to address the pandemic. The authorization was not a notice of compliance. In order for drugs to receive an NOC, a submission needs to be made under Division 8 of the Food and Drug Regulations.

The Food and Drug Regulations have been amended to allow for modified requirements that facilitate the regulatory process for new COVID-19 drugs to receive an NOC through a new drug submission (NDS). The amendments maintain some of the mechanisms introduced through the ISAD IO, thus continuing to provide Canadians with quick access to safe and effective COVID-19 drugs. This guidance document explains the modified requirements provided in these amendments to the Regulations.

For more information on these measures and the ISAD IO, refer to the following items:

Scope and application

COVID-19 means the coronavirus disease 2019. This guidance document applies to:

A “designated COVID-19 drug” is a new drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19. For the purpose of this document, COVID-19 drugs also include designated COVID-19 drugs.

For guidance on obtaining product authorization for disinfectants, hand sanitizers and veterinary health products, manufacturers should refer to the following guidance documents:

The amendments introduced in Part C, Divisions 1, 1A, 2 and 8 of the Regulations are described in this guidance document. The amendments introduce similar provisions found in the ISAD IO with regards to requirements for drug product authorizations, DEL applications and pre-positioning of products prior to authorization. The integration of these measures in the Regulations aims to give Canadians continued and timely access to safe and effective COVID-19 drugs.

Policy objectives

The objective of the amended Regulations is to allow for a mechanism for continued and timely access to safe and effective COVID-19 drugs. The review, authorization and oversight of these drugs will be conducted under the Regulations.

The amendments to the Regulations offer the following benefits:

Under the amended Regulations:

  1. Health Canada only grants an NOC for a COVID-19 drug under the Regulations if it’s determined that the benefits and risks of the product are supported by evidence of the drug’s safety, efficacy and consistent quality.
  2. Any uncertainties or risk mitigation measures related to the drug in the context of the public health need due to COVID-19 are managed through the use of terms and conditions.
  3. As with all drugs, Health Canada assesses and monitors the safety and effectiveness of all COVID-19 drugs for which an NOC was issued. If required, Health Canada takes immediate action, including compliance and enforcement measures and the suspension or cancellation of an NOC to protect the health and safety of Canadians.

Policy statements

Manufacturers of COVID-19 drugs may be able to obtain an NOC under the Regulations by leveraging certain options and modified requirements carried over from the ISAD IO.

These amendments to the Regulations allow for a submission for drugs to treat or prevent COVID-19 to be filed earlier through a “rolling submission” process. Manufacturers are responsible for completing the required documentation and providing the necessary evidence to Health Canada. COVID-19 drug submissions will be prioritized based on public health needs.

Licensing decisions are based on the materials submitted in the application. Health Canada will consider the necessity of the drug in addressing urgent COVID-19-related public health needs.

Manufacturers who have a valid authorization issued under the ISAD IO can file a new drug submission (NDS) under the Regulations. Sale of the drug may continue while the submission is in review, as long as it was filed within the 90-day period.

Where an expanded indication for COVID-19 was authorized under the ISAD IO for a marketed drug, the manufacturer is able to submit an SNDS to add the new COVID-19 indication. Modified requirements, including the ability to file a rolling submission, are not available to these SNDSs.

An NOC is not needed before September 16 to continue to sell, as long as an authorization was granted under the ISAD IO and a submission was filed within specified timelines. After September 16, if Health Canada has not issued an NOC, the ISAD IO authorization remains in effect until a decision is reached on the submission. (See section on “Timelines within which to file a submission under the Regulations to obtain a notice of compliance.”)

With this approach, manufacturers who initially obtained an authorization under the ISAD IO may submit an NDS with the same data as was included in their interim order application, along with any necessary updates. Where applicable, newly available data should be included in the NDS. To facilitate an expedited review, the sponsor should provide a summary of the submission package highlighting any changes. COVID-19 drugs are reviewed on an expedited timeline above the usual performance standards. As such, the Priority Review Policy does not apply.

Manufacturers who had their ISAD IO authorization revoked or who have never applied can also file an NDS submission leveraging the modified requirements for COVID-19 drugs in the Regulations.

Explanation of key terms

Designated COVID-19 drug: As defined in C.08.001.2, is a “new drug” under C.08.001. As such, it is subject to the requirements in Part C, Division 8 of the Food and Drug Regulations, including the:

For this document, designated COVID-19 drugs will be collectively referred to as COVID-19 drugs.

Drug: According to the Food and Drugs Act, includes any substance or mixture of substances manufactured, sold or represented for use in:

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. 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 accompanying notice and the relevant sections of other applicable guidance documents.

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