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WTO notification · TBT

CanadaIn force, according to its latest notice

Pharmaceutical products – Canada

Official title

Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

Canada issued an addendum on 17 July 2026 to the earlier TBT notification G/TBT/N/CAN/765. Addenda often report that a measure was adopted, changed, postponed or withdrawn. The measure was first notified on 5 January 2026. The comment period closed on 14 March 2026.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

Updated here:

At a glance

Products

Drugs

Notifying member
Canada
Status
In force, according to its latest notice
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CAN/765Latest notice: G/TBT/N/CAN/765/Add.3
ICS classification
  • 11.120 Pharmaceutics
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 14 March 2026
Proposed adoption
To be determined
Proposed entry into force
These proposed Regulations would come into force on the day of their publication in the Canada Gazette, Part II.

What the notification says

Latest notice (⁨G/TBT/N/CAN/765/Add.3⁩, 17 July 2026)

The latest notice says the measure has entered into force.

Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

The proposed measure notified in G/TBT/N/CAN/765 (dated 5 January, 2026) was adopted and published on 15 July, 2026, as the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (The Order). The Order will deem the regulatory requirement for the Minister to examine specified information and material in a submission or supplement for a new drug to have been met based on decisions of, or documents produced by, certain foreign regulatory authorities (FRAs). So that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it sets out requirements that will need to be met. These requirements include that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness. Information in the submission or supplement relating to those differences will be examined by the Minister along with other aspects of the submission or supplement unique to the Canadian market (e.g., labelling). Where the Minister considers that the differences could potentially negatively impact the safety…

The Government of Canada intends to make the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order). This Order would deem the requirement for the Minister to examine specified information and material in a new drug submission to have been met based on decisions or documents produced by certain foreign regulatory authorities (FRAs). To ensure that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it would set out requirements that would need to be met, including that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness. Information in the submission relating to those differences would be examined by the Minister along with other aspects of the submission unique to the Canadian market (e.g., labelling). Where the Minister considers that the differences could potentially negatively impact the safety and effectiveness of the drug, deeming would not be used for that component of the submission and a full examination would take place. Health…

Notices on this measure

Every notice about this measure published here, newest first. Each one is the notifying member's own text.

  1. AddendumG/TBT/N/CAN/765/Add.3

    Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

    The proposed measure notified in G/TBT/N/CAN/765 (dated 5 January, 2026) was adopted and published on 15 July, 2026, as the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (The Order). The Order will deem the regulatory requirement for the Minister to examine specified information and material in a submission or supplement for a new drug to have been met based on decisions of, or documents produced by, certain foreign regulatory authorities (FRAs). So that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it sets out requirements that will need to be met. These requirements include that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness. Information in the submission or supplement relating to those differences will be examined by the Minister along with other aspects of the submission or supplement unique to the Canadian market (e.g., labelling). Where the Minister considers that the differences could potentially negatively impact the safety…

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  2. AddendumG/TBT/N/CAN/765/Add.2

    Consultation on the proposed phased implementation of the Incorporated by reference list for the Ministerial Reliance Order

    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). The proposed Order was notified in G/TBT/N/CAN/765. Input received will be used to inform next steps related to the management of the list, including the approach to consultation for Phase 2 of the IbR list. This will help ensure that the policy for populating the IbR list is informed by and responsive to industry, downstream partners such as provinces and territories, other interested stakeholders and the public. The consultation opened on May 5, 2026, and Health Canada welcomes input until June 4, 2026.

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)Notified document 1 (opens in a new tab)Notified document 2 (opens in a new tab)Notified document 3 (opens in a new tab)Notified document 4 (opens in a new tab)

  3. AddendumG/TBT/N/CAN/765/Add.1

    Comment deadline: Closed on 14 March 2026

    Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

    The purpose of this Notification is to inform stakeholders that the opportunity to comment on the Ministerial Reliance Order package (G/TBT/N/CAN/765) has been extended. The consultation period that opened on 20 December 2025 has now been extended from 28 February 2026 to 14 March 2026 at 11:59 p.m. Eastern Daylight Time (EDT).

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)

  4. Regular notificationG/TBT/N/CAN/765

    Comment deadline: Closed on 18 February 2026

    Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs

    The Government of Canada intends to make the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order). This Order would deem the requirement for the Minister to examine specified information and material in a new drug submission to have been met based on decisions or documents produced by certain foreign regulatory authorities (FRAs). To ensure that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it would set out requirements that would need to be met, including that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness. Information in the submission relating to those differences would be examined by the Minister along with other aspects of the submission unique to the Canadian market (e.g., labelling). Where the Minister considers that the differences could potentially negatively impact the safety and effectiveness of the drug, deeming would not be used for that component of the submission and a full examination would take place. Health…

    Open on WTO ePing (opens in a new tab)Official WTO document (opens in a new tab)Notified document (opens in a new tab)

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

All updates from Canada

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    Symbol: G/SPS/N/CAN/1654

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    Regulations Amending the Clean Fuel Regulations (43 pages, available in English and French)

    The Clean Fuel Regulations (the Regulations) require regulated parties (producers and importers of gasoline or diesel) to reduce the lifecycle carbon intensity of the gasoline or diesel they produce or import for use in Canada. To achieve this, the Regulations establish annual lifecycle carbon…

    Symbol: G/TBT/N/CAN/785Comments until 14 January 2027

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