Guidance on the Food and Drug Regulations for public health emergency drugs: Overview

This guidance is a draft version for consultation purposes only. It is not to be implemented at this time.

This guidance applies to sponsors of new drug submissions or supplements to a new drug submission for public health emergency drugs for COVID-19 or a condition that is described in the List of Conditions that Threaten Public Health in Canada. It also applies to public health emergency drug establishment licences under the Food and Drug Regulations.

This document will help sponsors prepare a submission for a notice of compliance for a public health emergency drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements.

On this page

• Background
• Scope and application
• Policy objectives
• Policy statements
• Removal of a condition from the List
• Explanation of key terms
• Note about guidance documents in general

Background

The COVID-19 pandemic posed an immediate and significant risk to the health and safety of people in Canada. As the pandemic represented a public health emergency, Health Canada introduced interim measures. These included the Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO) and the COVID-19 drugs transition to the Food and Drug Regulations (regulations).

Health Canada is now expanding the provisions in Part C, Divisions 1A and 8 of the Regulations for activities related to COVID-19 and the authorization of COVID-19 drugs. The expanded provisions will also apply to a public health emergency drug, which is a drug that relates to COVID-19 or a condition referred to on the incorporated by reference (IbR) List of Conditions that Threaten Public Health in Canada (List).

This new authority for public health emergency drugs is introduced to:

• enable regulations that are agile in a public health emergency and
• apply modified requirements to address a public health emergency

This guidance document explains the modified requirements prescribed in these amendments to the regulations.

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

• Regulatory impact analysis statement: Regulations amending certain regulations made under the Food and Drugs Act (agile licensing)
• Canada Gazette, Part I Regulations

For more information about documents incorporated by reference, refer to Health Canada Incorporation by Reference Policy.

Scope and application

This guidance document applies to:

• sponsors planning to file a submission for a notice of compliance (NOC) for a public health emergency drug as defined in C.08.001.1 of the regulations, whether or not they are taking advantage of modified requirements
• public health emergency drugs filed and/or authorized under the Food and Drug Regulations for COVID-19 or for a condition that is described in the List of Conditions that Threaten Public Health in Canada (List)
• establishments seeking a drug establishment licence (DEL) related to public health emergency drugs
• pre-positioning of public health emergency drugs (C.08.009.03)

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

• Management of drug submissions and applications
• Management of disinfectant drug applications
• Human-use antiseptic drugs
• Antiseptic skin cleansers (personal domestic use)
• Veterinary health products: About the VHP notification program

The amendments introduced in Part C, Divisions 1, 1A, 2 and 8 of the regulations are described in this guidance document.

The amendments expand the application of measures introduced with regard to requirements for drug product authorizations, terms and conditions, DEL applications and pre-positioning of products prior to authorization for COVID-19 to other conditions that threaten public health. The aim is to give people in Canada continued and timely access to safe and effective public health emergency drugs.

Policy objectives

The objective of the amendments to the regulations is to allow for a mechanism for continued and timely access to safe and effective public health emergency drugs.

The amendments to the regulations offer the following tools to enable:

• access to safe, effective and high-quality public health emergency drugs
• modified requirements (for example, rolling review, labelling and sufficient safety, quality and efficacy evidence) and terms and conditions
• the early importation and placement in Canadian facilities (pre-positioning) of a promising public health emergency drug for which a federal government contract for its procurement is in place, before that drug receives market authorization in Canada
• an agile approach for DELs that authorizes regulated activities for public health emergency drugs
• post-market regulatory obligations placed on authorization holders, manufacturers and importers

Under the amended regulations:

• Health Canada only grants an NOC for a public health emergency drug 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.
• When making its decision, Health Canada considers the public health need as well as the uncertainties related to the benefits and risks of the product. Terms and conditions will be used to help manage any uncertainties or risks related to the drug in the context of COVID-19 or the condition on the List.
• As with all drugs, Health Canada assesses and monitors the safety and effectiveness of all public health emergency drugs for which an NOC was issued.
  • If required, Health Canada takes immediate action, including compliance and enforcement measures and the suspension of an NOC or the cancellation of a DIN, to protect the health and safety of people in Canada.

Policy statements

Manufacturers of public health emergency drugs may be able to obtain an NOC under the regulations by leveraging certain options and modified requirements.

These amendments to the regulations allow for a submission for public health emergency drugs to treat or prevent COVID-19 or a condition on the List to be filed earlier through a "rolling review" process. Manufacturers are responsible for completing the required documentation and providing the necessary evidence to Health Canada. Public health emergency 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 use of the drug in addressing a condition that threatens public health.

Public health emergency drugs are reviewed on an expedited timeline above the usual performance standards. As such, the Priority Review Policy does not apply.

Manufacturers with a proposed public health emergency drug for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19 or a condition on the List can file a new drug submission (NDS) or a supplement to a new drug submission (SNDS) leveraging the modified requirements for public health emergency drugs in the regulations.

Removal of a condition from the List

A drug remains a public health emergency drug for the purposes of Division 8 until the Minister makes a final decision on the submission under C.08.004, if:

• a condition is removed from the List after a sponsor files a new drug submission for a public health emergency drug in accordance with subsections C.08.002(2) to (2.5) and section C.08.005.1 but
• before the Minister makes a final decision on the submission under section C.08.004 (C.08.001.3)
• a record of each version of the List is maintained

Refer to Health Canada Incorporation by Reference Policy for more information.

Explanation of key terms

List of Conditions that Threaten Public Health: The List of Conditions that Threaten Public Health in Canada is an IbR List published on the Government of Canada's website and amended from time to time.

The Minister may add a condition to the List if the Minister has reasonable grounds to believe that:

1. the condition presents, or is the result of, a significant risk to public health in Canada and
2. immediate action is required to deal with the risk (C.08.001.2)

Public health emergency drug: As defined in C.08.001.1, this is a "new drug" under C.08.001 for which the purpose and conditions of use recommended by the manufacturer relate to COVID-19 or a condition that is described in the List.

A public health emergency drug is subject to the requirements in Part C, Division 8 of the Food and Drug Regulations.

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.