Canada Profile Updated

July 18, 2025
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The Canada profile in ClinRegs has been reviewed and updated with the following information:

  • Details on Health Canada’s (HC) inspection responsibilities and compliance program (See Scope of Assessment)
  • Information on registering as a trading partner with the US Food & Drug Administration (FDA) at the FDA Electronic Submissions Gateway Next Generation (See Submission Process)
  • Additional details on HC’s Pharmaceutical Drugs Directorate’s responsibilities (See Regulatory Authority)
  • Updated information on provincial and territorial privacy laws and oversight from the Office of Privacy Commissioner (See Additional Resources)

Sources Added During this Update:

(Guidance) POL-0030: Compliance and Enforcement Approach and Inspection Strategy for Clinical Trials of Drugs Involving Human Subjects (G-Inspections) (November 30, 2021)
Health Canada

(Webpage) ESG NextGen Frequently Asked Questions (CAN-54) (Last Updated April 12, 2025)
U.S. Food and Drug Administration

Sources Revised During this Update:

(Webpage) Electronic Submissions Gateway Next Generation (ESG NextGen) (CAN-51) (Current as of July 17, 2025)
U.S. Food and Drug Administration

(Webpage) Health Products and Food Branch (CAN-16) (Last Updated March 21, 2025)
Health Products and Food Branch, Health Canada

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