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Common menu bar links

Drugs and Health Products

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.

Other:

  • Inspection Strategy for Clinical Trials

Forms and Templates

Forms:

Templates:

Instructions for Completing Forms/Templates

Useful Internet Websites