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WTO notification · TBT

CanadaUpdated: check whether it is now adopted or in force

Pharmaceutical products – Canada

Official title

Clinical Trials Regulations (145 pages, available in English and French) & Regulations Amending Certain Regulations Relating to Clinical Trials (8 pages, available in English and French)

Canada issued an addendum on 12 March 2026 to the earlier TBT notification G/TBT/N/CAN/766. Addenda often report that a measure was adopted, changed, postponed or withdrawn.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 19 April 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
Updated: check whether it is now adopted or in force
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/CAN/766Latest notice: G/TBT/N/CAN/766/Add.2
ICS classification
  • 11.120 Pharmaceutics
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Closed on 19 April 2026
Proposed adoption
To be determined
Proposed entry into force
- Clinical Trials Regulations: These proposed Regulations come into force on the first anniversary of the day on which they are published in the Canada Gazette, Part II. - Regulations Amending Certain

How to comment

The comment period closed on 19 April 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/CAN/766/Add.2; it can take them up with Canada.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

Latest notice (⁨G/TBT/N/CAN/766/Add.2⁩, 12 March 2026)

Comment Period Extension for Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials

The purpose of this Notification is to inform stakeholders that the opportunity to comment on the proposed Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials (G/TBT/N/CAN/766) has been extended. The consultation period that opened on 20 December 2025 has now been extended from 20 March 2026 to 19 April 2026 at 11:59 p.m. Eastern Daylight Time (EDT). In addition, the opportunity to comment on the Updated proposal on Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials(G/TBT/N/CAN/766/Add.1) related to the proposed policy for clinical trials involving cells, tissues, and organs, and the proposed policy for clinical trials involving blood and blood components has been extended. The consultation period that opened on 2 February 2026 has now been extended from 20 March 2026 to 19 April 2026 at 11:59 p.m. Eastern Daylight Time (EDT).

The proposed Regulations would establish a new, standalone regulatory framework under the Food and Drugs Act for clinical trials involving drugs for human use. This proposed framework would replace the existing clinical trial regulatory schemes for drugs in Part C, Division 5 of the Food and Drug Regulations (FDR) and Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (COVID-19 CT Regulations). It would regulate both the conduct of clinical trials and the importation and sale of drugs used in these trials. Specifically, it would establish requirements for the importation and sale of drugs to be used in a clinical trial as well as the application process for the issuance of an authorization to conduct a trial and the oversight mechanisms. It would also set out requirements for good clinical practices, reporting, and other activities related to clinical trials. Additionally, the proposed Regulations would repeal Part C, Division 5 of the FDR and Part 2 of the COVID-19 CT Regulations and would make several consequential amendments to other provisions of the FDR, the COVID-19 CT Regulations and other related regulations to align them with the new framework.

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/766/Add.2

    Comment deadline: Closed on 19 April 2026

    Comment Period Extension for Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials

    The purpose of this Notification is to inform stakeholders that the opportunity to comment on the proposed Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials (G/TBT/N/CAN/766) has been extended. The consultation period that opened on 20 December 2025 has now been extended from 20 March 2026 to 19 April 2026 at 11:59 p.m. Eastern Daylight Time (EDT). In addition, the opportunity to comment on the Updated proposal on Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials(G/TBT/N/CAN/766/Add.1) related to the proposed policy for clinical trials involving cells, tissues, and organs, and the proposed policy for clinical trials involving blood and blood components has been extended. The consultation period that opened on 2 February 2026 has now been extended from 20 March 2026 to 19 April 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)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)Notified document 5 (opens in a new tab)Notified document 6 (opens in a new tab)

  2. AddendumG/TBT/N/CAN/766/Add.1

    Comment deadline: Closed on 20 March 2026

    Updated proposal on Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials

    On December 23, 2025, proposed amendments to the Clinical Trials Regulations and Regulations Amending Certain Regulations Relating to Clinical Trials were notified in G/TBT/N/CAN/766. The proposed Regulations would establish a new, standalone framework under the Food and Drugs Act for clinical trials involving drugs for human use. The purpose of this addendum is to consult stakeholders on proposed policy for: clinical trials involving CTOs with the proposed Clinical Trials Regulations; and; clinical trials involving blood and blood components (herein referred to as blood) with the proposed Clinical Trials Regulations. Clinical trials involving CTOs CTOs are typically regulated under the Safety of Human Cells, Tissues, and Organs Regulations (CTOR). The CTOR provides a framework designed to minimize potential health risks by establishing safety requirements for the processing and handling of CTOs that are transplanted under standard medical practice. However, when CTOs are used as investigational products in a clinical trial, they are subject to Canada’s clinical trial regulations instead. Health Canada is proposing an exemption from the requirement to hold a clinical trial authorization under the proposed Clinical Trial Regulations for low-risk trials in which the cell, tissue or organ that is being investigated is minimally manipulated and is used for the same basic function in the recipient as in the donor (i.e. homologous use), provided no other drugs are being used in…

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

  3. Regular notificationG/TBT/N/CAN/766

    Comment deadline: Closed on 20 March 2026

    Clinical Trials Regulations (145 pages, available in English and French) & Regulations Amending Certain Regulations Relating to Clinical Trials (8 pages, available in English and French)

    The proposed Regulations would establish a new, standalone regulatory framework under the Food and Drugs Act for clinical trials involving drugs for human use. This proposed framework would replace the existing clinical trial regulatory schemes for drugs in Part C, Division 5 of the Food and Drug Regulations (FDR) and Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (COVID-19 CT Regulations). It would regulate both the conduct of clinical trials and the importation and sale of drugs used in these trials. Specifically, it would establish requirements for the importation and sale of drugs to be used in a clinical trial as well as the application process for the issuance of an authorization to conduct a trial and the oversight mechanisms. It would also set out requirements for good clinical practices, reporting, and other activities related to clinical trials. Additionally, the proposed Regulations would repeal Part C, Division 5 of the FDR and Part 2 of the COVID-19 CT Regulations and would make several consequential amendments to other provisions of the FDR, the COVID-19 CT Regulations and other related regulations to align them with the new framework.

    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)

Sources

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

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