Canada Profile Updated with Additional Details on Therapeutic Products Oversight and ICH Guidelines Implementation

October 1, 2024
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The Canada profile in ClinRegs has been updated with the following information:

  • Information related to the Minister of Health’s regulatory authority regarding therapeutic products that may present a risk of injury to health (See Regulatory Authority)
  • Webpage providing details on Health Canada’s implementation of International Council for Harmonisation (ICH) guidelines
  • Updated links to ICH guidelines implemented in Canada

Sources Added During this Update:

(Webpage) International Council for Harmonisation (ICH) – Guidelines (CAN-50) (Last Updated February 27, 2024)
Health Canada

Sources Revised During this Update:

(Legislation) Food and Drugs Act (R.S.C., 1985, c. F-27) (CanadaFDA – English and French) (Last Amended June 20, 2024)
Parliament of Canada

(International Guidance) ICH Harmonised Tripartite Guideline: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (E2A) (CAN-48) (Step 5 Version) (October 27, 1994)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2) (CAN-52) (Step 5 Version) (November 9, 2016)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(International Guidance) Statistical Principles for Clinical Trials ICH Topic E9: Guidance for industry (CAN-53) (Step 5 Version) (February 10, 2003)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

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