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March 16 , 2018

Network of Networks (N2) is working in partnership with Health Canada (HC) on their consultation to seek input from Canadians and key stakeholders on their draft of GUI-0100: Guidance Document-Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”.

HC 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, as a member of ICH, will formally adopt ICH-E6(R2) on April 1st, 2018.

This GUI-0100 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)

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)

TIMELINE

Feedback will be collected up until April 15th, 2018.

As an N2 member, we encourage you to provide your feedback through the N2 mechanism to support Health Canada’s structured approach and to facilitate collation of the feedback.

Access GUI-0100 draft guidance document in English

Access GUI-0100 draft guidance document in French.

Provide feedback

 

If you have questions, related to N2’s involvement with Health Canada’s consultation on GUI-0100 please contact:

Karen Arts- N2 Chair, Board of Directors

Susanna Sellmann-N2 Quality Committee

karen.arts@n2canada.ca

Susanna.Sellmann@uhnresearch.ca

Tel: 416.673.6637

Tel: 416.946.4501 x3221

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