Feedback request on Health Canada guidance GUI-0100

Drugs for Clinical Trials Involving Human Subjects
Wednesday, February 28, 2018

The Canadian Cancer Trials Group (CCTG), as a major stakeholder, has been invited to provide input on the Health Canada draft of GUI-0100: Guidance Document - Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects." As a valued member of CCTG we would like to request your input to the CCTG response. Please see the Health Canada published Notice of Consultation at: https://www.canada.ca/en/health-canada/programs/consultation-drugs-clinical-trials-involving-human-subjects.html and the draft guidance English and French links below:

As per the Notice of Consultation, 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)

While we understand that you may have other avenues to comment on the draft guidance for GUI-0100: Guidance Document - Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" we sincerely hope that you will consider sharing your thoughts on the draft guidance with CCTG as we draft a response on your behalf.

Please submit responses by April 2nd, 2018 to: guidancefeedback@ctg.queensu.ca