Consultation on “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations)

From Health Canada

Current status: OPEN

Between December 15th, 2017 and April 15th, 2018 Health Canada is seeking input from Canadians and key stakeholders on the draft of GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”.

Why

Health Canada is looking for your input on the draft guidance for GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects. This guide is designed to make Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” easier to understand. It is intended to:

  • promote stakeholder compliance with Part C, Division 5
  • promote consistency and quality in the conduct of Health Canada compliance activities
  • provide interpretation of Part C, Division 5, and specifically in terms of its relationship to ICH E6(R2)

Sponsors must ensure that their clinical trials are in compliance with regulatory requirements and good clinical practices. Sponsors who test drugs on human subjects (under Part C, Division 5 of the Food and Drug Regulations) must use good clinical practices to ensure that subjects’ rights, safety, and well-being are protected. Sponsors must also ensure that the data generated from a trial are reliable and accurate, so that they can be used to support the approval of a drug, or inform current clinical standards of practice with respect to the use of certain medications.

Who

We are seeking comments from:

  • Clinical trial stakeholders, such as:
    • Sponsors
    • Qualified investigators (QIs)
    • Contract research organizations (CROs)
    • Site management organizations (SMOs)
    • Academia and researchers
  • Clinical trial subjects and related patient groups
  • The general public

What

Health Canada is looking for comments on:

  • The clarity and expectations on how to comply with Part C, Division 5, including the interpretation of ICH E6(R2) in the Canadian context

Health Canada is not looking for comments on:

  • The wording or specific provisions of Part C, Division 5 of the Food and Drug Regulations
  • The wording and provisions of ICH E6(R2)

When and where

Feedback will be collected between December 15th, 2017 and April 15th, 2018.

Health Canada is partnering with several organizations for this consultation. Please see below on how to participate.

How to participate

There are 3 ways to participate:

  1. If you, or your employer, are a member of any of the following organizations, you may choose to provide your feedback to these organizations so that they can provide a consolidated response to Health Canada, representative of the views of their members. You may contact the individual organizations to learn more about their engagement approach with their members on this consultation:

  2. If you are a patient who is interested in clinical trials, you may send your comments directly to Health Canada (see #3), or contact one of the organizations or their member organizations below, who will be holding a patient focus group, to solicit feedback. For more information, please contact:

  3. For all other interested parties, please contact Health Canada to obtain a copy of the consultation document and Comment Form at the following coordinates
    • email at: GCP_BPC@hc-sc.gc.ca
                    Please include “GUI-0100 Consultation” in the subject line
    • fax at:    613-960-2156
    • post at: Clinical Trial Compliance Program
                   Rm 1455C, 14th Floor, Jeanne Mance Building
                   200 Eglantine Driveway
                   Address Locator 1914C
                   Ottawa, ON K1A 0K9        

Related information

Contact us

Clinical Trial Compliance Program
14th floor, 200 Eglantine Driveway
Address Locator 1914C
Ottawa, ON K1A 0K9

Telephone: 613-946-8844
Email: GCP_BPC@hc-sc.gc.ca

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