Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100): Overview

Disclaimer: This document does not constitute legislation. In the event of any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

Date issued: March 2, 2026

Date implemented: April 1, 2026

Replaces: Guidance Document: Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100), version 2

On this page

• Purpose
• Scope
• Introduction
• Guidance for implementation

Purpose

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Scope

This guidance document applies to you if you are a party involved in the conduct of clinical trials of drugs in human participants in Canada.

Interested parties may include:

• sponsor
• qualified investigator (QI)
• service provider (SP)

The Regulations clearly establish that the sponsor has the overall responsibility for conducting a clinical trial involving drugs in human participants. In Canada, a sponsor may transfer responsibility for any or all trial related duties to other parties. However, sponsors remain accountable in all respects for the trial's data quality and integrity, and participant safety.

The Regulations do not differentiate between a commercial and a non-commercial sponsor (for example Sponsor-Investigator) and as such, the same requirements apply.

This guidance document covers the following clinical trials of drugs conducted in humans in Canada:

• Phase I to IV
• commercial or academic
• ongoing or completed
• clinical trials involving pharmaceuticals, biologics, gene therapies, cell therapies, blood products, vaccines and radiopharmaceuticals for human use

This document does not apply to:

• clinical trials studying medical devices
• clinical trials studying natural health products (NHPs)
• observational studies, which do not include drug intervention

Introduction

The legislative authority for the Food and Drug Regulations, Part C, Division 5 "Drugs for Clinical Trials Involving Human Subjects" is the Food and Drugs Act (the Act). The Regulations came into force on September 1, 2001 and set out the federal requirements for the sale and importation of drugs used in human clinical trials in Canada, and include the requirement to comply with good clinical practices (GCP). Health Canada does not have jurisdiction over the professional standards regarding practice of medicine, which are enforced by the provincial colleges of physicians.

Part C, Division 5 of the Regulations provides for flexibility to follow international GCP standards in order to satisfy the requirements of the Regulations.

Health Canada adopted the International Council on Harmonization Guidance: Good Clinical Practice Consolidated Guideline (ICH E6). ICH E6 is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve participants.

The ICH E6 Guideline is amended as the clinical trials landscape evolves in scale and complexity. Evolutions in technology and risk management processes offer new opportunities to focus on relevant activities resulting in increasing the rigour of clinical trials. In 2025, Health Canada adopted ICH E6(R3) to provide guidance about topics including:

• expectation for risk-based approaches including Quality by Design principles and Risk Management
• identifying critical-to-quality factors and having supporting elements that are fit-for-purpose
• roles and responsibilities for sponsors, investigators and service providers
• elements of data governance

The ICH guidance E6(R3) Good Clinical Practice was fully adopted by Health Canada as of April 1, 2026.

It is important to note that local regulations in ICH regions can exceed the requirements of ICH E6. As such, ICH guidelines should be used in conjunction with the relevant federal regulations, guidance documents and any other regional, institutional or local requirements.

Health Canada has recognized a need to provide guidance in the interpretation of Part C, Division 5 of the Regulations, and specifically in terms of its relationship to ICH E6. This guidance document is intended to fulfill this need, as well as to provide additional guidance where is necessary or when ICH E6 does not apply.

Compliance with the Regulations and ICH E6 will further promote the protection of participants as well as ensure the integrity of the data generated by the trial, whether it is for use in academic publications, or to support new, supplementary or abbreviated drug submissions (NDS, SNDS, ANDS).

For detailed guidance on clinical trial applications (CTA) and amendments (CTA-A), you should refer to Guidance document for clinical trial sponsors: Clinical trial applications and if applicable, to Guidance document: Preparation of clinical trial applications for use of cell therapy products in humans.

Guidance for implementation

Guidance on interpretation of Part C, Division 5 of the Regulations is provided in this document. In interpreting the Regulations, ICH E6 should be used in conjunction with the Act, the Regulations, and any relevant policies and guidelines.

In this document, where guidance to a specific regulation can be found in ICH E6, the section in ICH E6 is noted. If necessary, or where ICH E6 is not applicable, additional guidance is provided or other guidance documents are referenced.

At all times, where the Regulations exceed the guidance set out in this document or those in ICH E6, the Regulations take precedence.