Relevant Links

Food and Drugs Act and Regulations

Links to sections of the Regulations relevant to the conduct of clinical trials (Part C, Division 5 of the Regulations: Drugs for Clinical Trials Involving Human Subjects):

Guidance documents

Guidance Documents - Clinical Trial Applications:

Quality Guidance Document for Pharmaceuticals:

Quality Guidance Documents for Biologics:

Guidance Documents - Positron Emitting Radiopharmaceuticals:

Guidance Document - Pharmacogenomic Information:

Health Canada / ICH Guidance Documents:

Additional Health Canada / ICH Guidance Documents are also available on Health Canada's Drugs and Health Products website.


  • Inspection Strategy for Clinical Trials

Forms and Templates



Instructions for Completing Forms/Templates

Useful Internet Websites

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