Guidance on the Food and Drug Regulations for public health emergency drugs: Overview
This guidance applies to:
- sponsors of new drug submissions or supplements to a new drug submission for:
- public health emergency drugs for COVID-19
- a condition that is described in the List of conditions that threaten public health in Canada
- 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
- Explanation of key terms
- Removal of a condition from the list
- 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. Health Canada introduced interim measures to address the pandemic, as it represented a public health emergency. These included the:
- Interim order respecting the importation, sale and advertising of drugs for use in relation to COVID-19 (ISAD IO)
- COVID-19 drugs transition to the Food and Drug Regulations (regulations)
The provisions in Part C, Divisions 1A and 8 of the regulations have been expanded to apply to activities related to public health emergency drug (PHED). These drugs relate to a condition referred to on the List of conditions that threaten public health in Canada (list) that is incorporated by reference (IbR).
This authority for a PHED is intended to enable an agile response to a public health emergency through modified requirements under the regulations.
This guidance document explains:
- eligibility criteria for a sponsor to make use of the modified requirements prescribed by the regulations
- how those modified requirements enable an agile response to a public health emergency
For more information on these measures:
For more information about documents incorporated by reference:
Scope and application
This guidance document applies to:
- sponsors planning to file a submission for a notice of compliance (NOC) for a PHED as defined in C.08.001.1 of the regulations
- a submission for a PHED that has been filed and/or authorized
- establishments seeking a drug establishment licence (DEL) related to a PHED
- pre-positioning of a PHED (C.08.009.01 to 05)
This guidance document does not apply to drug submissions that are substantively not related to a PHED and a condition on the list.
List of conditions that threaten public health in Canada
The amendments to Part C, Divisions 1, 1A, 2 and 8 of the regulations have expanded to apply modified requirements to drugs that:
- treat conditions that threaten public health and
- have been added to the list
These modified requirements were introduced in respect of activities related to COVID-19 drugs :
- Drug authorizations.
- Terms and conditions.
- DEL applications.
- Pre-positioning of products before authorization.
You can also review a new drug submission (NDS) for a human PHED under the:
- New Active Substances Work-Sharing Initiative (NASWSI)
- European Medicines Agency's (EMA) "Opening our Procedures at EMA to Non-EU authorities (OPEN)" project
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
Policy objectives
The objective of the amendments to the regulations is to provide people in Canada with continued and timely access to PHEDs that meet the safety, efficacy and quality requirements.
The amendments to the regulations enable:
- timely access to PHEDs that meet the safety, efficacy and quality requirements
- modified requirements, for example:
- draft labels
- the option of a rolling review
- sufficient safety, quality and efficacy evidence
- pre-positioning unapproved PHEDs with government procurement contracts in place in Canadian facilities before that drug receives market authorization in Canada
- an agile approach for DELs that authorizes regulated activities for PHEDs
- terms and conditions (obligations placed on authorization holders, sponsors and importers)
Under the amended regulations, Health Canada only grants an NOC for a PHED if it's determined that the benefits outweigh the risks of the product as 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. This only applies should the sponsor decide to use C.08.002(2.1)) or C.08.003(5).
As with all drugs, Health Canada assesses and monitors the safety and efficacy of all PHEDs for which an NOC was issued. If required, Health Canada takes immediate action to protect the health and safety of people in Canada, including:
- suspending an NOC
- compliance and enforcement measures
- cancelling a drug identification number (DIN)
Policy statements
Sponsors with a proposed PHED for which the purpose and conditions of use recommended by the sponsor relate to a condition on the list can file:
- a new drug submission (NDS), or
- a supplement to a new drug submission (SNDS)
This lets sponsors obtain an NOC by using certain options and modified requirements under the regulations.
These amendments to the regulations allow sponsors to file a PHED submission earlier through a "rolling review" process. Rolling review allows Health Canada to start reviewing sponsor-provided information earlier. However, Health Canada's review depends on the sponsor completing the rolling review dossier. Sponsors are responsible for completing the required documentation and providing the necessary evidence to Health Canada. We'll prioritize PHED submissions based on public health needs.
Authorization decisions are based on the materials submitted in the application. Health Canada will consider the use of the drug when addressing a condition on the list.
PHED submissions are reviewed on an expedited timeline.
However, the modified requirements are only available where the submission relates to the condition on the list. For example, a submission may seek to add a new indication to an approved PHED to treat a condition that is not included on the list. This submission will not be able to leverage modified requirements.
Learn more:
Explanation of key terms
List of conditions that threaten public health
The List of conditions that threaten public health in Canada as defined in C.08.001.1 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 (C.0.08.001.2(1)) if the Minister has reasonable grounds to believe that:
- the condition presents, or is the result of, a significant risk to public health in Canada and
- immediate action is required to deal with the risk (C.08.001.2)
However, the Minister may add COVID-19 to the List of conditions that threaten public health if the Minister has reasonable grounds to believe that the addition is necessary to protect public health or safety.
Learn more:
- Health Canada's Incorporation by Reference Policy
- List of conditions that threaten public health in Canada
Public health emergency drug
Defined in C.08.001.1 as a "new drug" 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 PHED is subject to the requirements in Part C, Division 8 of the regulations.
Removal of a condition from the list
Once a condition is included on the list the Minister can amend it, including removing a condition at any time. This is because the list is considered a regulation under the Interpretation Act.
A condition may be removed from the list after:
- a DEL submission has already been filed, or
- a submission for a PHED to treat the removed condition has already been filed
If so, the submission will continue to be a submission under review for a PHED until Health Canada issues a decision under C.08.004, if:
- a condition is removed from the list after a sponsor files a drug submission for a PHED but
- before the Minister makes a final decision on the submission under section C.08.004 (C.08.001.3)
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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