Health Canada seeks feedback on the proposed phased implementation of the incorporated by reference list for the Ministerial Reliance Order: Notice

On this page

• Purpose of the notice
• Background
• Proposed approach for the incorporated by reference list
• Seeking your feedback

Purpose of the notice

The purpose of this notice is to seek feedback on the proposed phased implementation process for developing and updating the incorporated by reference (IbR) list. The list would set out the classes of drugs and the foreign regulatory authorities (FRAs) for the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (Order).

Background

Health Canada is proposing to publish the Order in summer 2026. The Order would deem the requirement for the Minister to examine specified information and material in a drug submission under Part C, Division 8 of the Food and Drug Regulations to have been met in specific circumstances. This determination would be based on decisions or documents produced by certain FRAs.

The Order addresses three scenarios:

1. General deeming: drug submissions for which a decision has already been made by an FRA about a foreign drug
2. 120-day filing: drug submissions for which a decision by an FRA to authorize a foreign drug has not yet been made, provided the submissions are filed in Canada within 120 days of being filed with an FRA
3. Joint reviews: drug submissions subject to joint review by Health Canada with one or more FRA

The Order would not provide a separate pathway to market authorization. It is meant to be a regulatory tool to help encourage earlier availability of drugs on the Canadian market by facilitating more efficient reviews of drug submissions by Health Canada and enabling greater international collaboration.

The Order would include an IbR list that would set out classes of drugs and FRAs within its scope. Classes of drugs would be set out on the IbR list, as well as the FRAs whose decisions or documents can be used for deeming with respect to specific classes of drugs. If relevant, a qualifier may be added to the drug class to further define which drug submissions are eligible under the Order. Deeming could only apply to a drug submission for a drug that falls within a class of drugs identified on the relevant part of the IbR list.

The structure of the IbR list may evolve, including based on feedback received through the Canada Gazette, Part I consultation. At this time, the IbR list is envisioned to be divided to align with the deeming options in the Order:

1. Part 1, Subpart 1: General deeming of new drug submissions (NDS) and their supplements (SNDS)
2. Part 1, Subpart 2: 120-day filing
3. Part 1, Subpart 3: General deeming of abbreviated NDS (ANDS) and their supplements (SANDS)
4. Part 2: Joint reviews

Proposed approach for the incorporated by reference list

Health Canada intends for the Order to come into force upon publication in Canada Gazette, Part II (CGII). Health Canada intends to consult on draft guidance related to the implementation of the Order at the time of the CGII publication.

Prior to adding a class of drugs or a Foreign Regulatory Authority (FRA) to the IbR list, the Minister would assess whether:

• the addition is necessary for a health or safety purpose or is otherwise in the public interest and
• it is unlikely to result in unacceptable risks or uncertainties related to health, safety or, if applicable, the environment, based on the Order’s benefits and conditions

The potential impact on Canadian manufacturers may be considered before a class of drugs is added to the IbR list.

The decision to add an FRA with respect to a class of drugs on the IbR list would take into account several factors. A key factor would be whether an FRA is comparable to Health Canada for that class. Other factors would include whether:

1. the FRA’s regulatory framework and practices are sufficiently similar to Health Canada's, particularly in terms of what factors need to be taken into account in regulatory decisions
2. the FRA complies with guidelines and international standards comparable with those adopted by Health Canada and
3. Health Canada has a formalised framework of collaboration and/or information sharing with the FRA

Where relevant, Health Canada may also examine FRA-specific factors that help mitigate unacceptable health and safety risks associated with a specific class of drugs.

To allow Health Canada and industry time to gain experience with the Order, and to learn how to use it most effectively, Health Canada is proposing a phased approach to populating the IbR list after the Order comes into force. As part of this notice, we are providing information on the classes of drugs and FRAs expected to be included in the first version of the IbR list. This initial version of the IbR list would be made available when the Order is published in CGII.

Health Canada is committed to transparently engaging with impacted stakeholders before listing additional classes of drugs and FRAs. This engagement would occur, for example, following publication of the Order in CGII and the initial IbR list, and would be guided by the Health Canada Incorporation by Reference Policy.

Health Canada Incorporation by Reference Policy

Human drugs

Part 1, Subpart 1: General deeming for (S)NDS

Taking into account the health and safety purpose of the Order, the focus in the first phase of implementation would be to include a smaller subset of classes of drugs. These classes would focus on areas of therapeutic gaps identified through prior consultation activities undertaken by the department. Taking this approach would also allow for development of successful implementation strategies and operationalisation procedures in collaboration with stakeholders.

During this first phase, it is proposed that the IbR list under Part 1, Subpart 1 would consist of certain classes of drugs to address therapeutic gaps that have been previously identified, such as human drug classes with pediatric conditions of use. Additional information about which classes of drugs would qualify will be available at CGII.

Pending further engagement, this subpart of the IbR list would expand to include additional classes of human drugs during phase 2.

Part 1, Subpart 2: 120-day filing

The addition of classes of drugs to this subpart of the list would be considered in phase 2 via a targeted approach. This would allow Health Canada to incorporate lessons learned from the implementation of Part 1, Subpart 1 into the implementation of the 120-day filing process.

Part 1, Subpart 3: Abbreviated NDS (ANDS) and their supplements (SANDS)

Some industry stakeholders have indicated that the Order could potentially have negative impacts on Canadian companies whose operations and product development are primarily focused in Canada. The population of this subpart of the list would be considered in phase 3, which aligns with the approach that will be taken with respect to biosimilars.

Part 2: Joint reviews

This Order is designed to enable Health Canada to use pre-existing mechanisms to better collaborate with partner FRAs as part of joint reviews in the Minister’s examination of (S)NDSs under the FDR. It is the intention of Health Canada to leverage these existing processes and expertise for full implementation of the joint review option of the Order during phase 1 for submissions participating in the Access Consortium New Active Substance Medicines Work Sharing Initiative. FRAs would include:

• Health Sciences Authority (HSA) of Singapore
• Therapeutic Goods Administration (TGA) of Australia
• Swiss Agency for Therapeutic Products of Switzerland
• Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom

Veterinary drugs

The following veterinary drug classes are proposed to be listed on the IbR list under Part 1 upon publication:

Drugs for food-producing animal use:

• All classes of veterinary drugs, as authorized by the United States Food and Drug Administration (US FDA), United Kingdom Veterinary Medicines Directorate (UK VMD), European Commission (EC), New Zealand Ministry for Primary industries (NZMPI) and Australian Pesticides and Veterinary Medicines Authority (APVMA), except:
  • antimicrobials which would be limited to antimicrobial veterinary drugs, as authorized by the US FDA

Drugs for non-food-producing animal use:

• All classes of veterinary drugs, as authorized by the US FDA, UK VMD, EC, NZMPI and APVMA, except:
  • antimicrobials, excluding antiparasitic veterinary drugs, which would be limited to antimicrobial veterinary drugs, as authorized by the US FDA, UK VMD and EC, except:
    • antiparasitic veterinary drugs, as authorized by the US FDA

Notes:

• Antimicrobials are to be interpreted as including antibiotics, antivirals, antiparasitics, anticoccidials and antifungals.
• No veterinary drug classes are proposed for Part 2, joint reviews, at this time.
• Health Canada will continue to examine the label for all new drugs. Additionally, Health Canada will continue to examine the withdrawal period of a new drug if intended for administration to food-producing animals.

Seeking your feedback

The publication of this notice initiates a 30-day public comment period.

Visit the consultation to learn how you can participate.