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”.
Health Canada is looking for your input on the draft guidance for GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects.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.
We are seeking comments from:
Clinical trial stakeholders, such as:
- Qualified investigators (QIs)
- Contract research organizations (CROs)
- Site management organizations (SMOs)
- Academia and researchers
- Clinical trial subjects and related patient groups
- The general public
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.
How to provide feedback
Health Canada is partnering with several organizations for this consultation. CellCAN is one of the 3 organizations mandated to provide a consolidated response to Health Canada, representing the views of our network and partners.
To provide feedback, please fill out the following documents and send them back to: Craig Hasilo, firstname.lastname@example.org, 514-252-3400 x.4137. You can use the Word OR Excel Template to provide feedback.