Health Canada Regulations and Applicable Policies

All clinical trials filed with Health Canada must comply with;
• The International Conference on Harmonization (ICH) Guidance for Good Clinical Practice (GCP).

All clinical trials filed with Health Canada must also comply with their respective regulations:

Pharmaceutical, Biological and Radiopharmaceutical Drugs:

• Part C (Drugs) Division 5 (Drugs for Clinical Trials Involving Human Subjects) of the Food and Drug Regulations 2001.

Natural Health Products and Non-prescription drugs: 

• Part 4 (Clinical Trials Involving Human Subjects) of the Natural Health Products Regulations 2003.

Medical Devices:

• Part 3 (Medical Devices for Investigational Testing Involving Human Subjects) of the Medical Devices Regulations 1998, and
• International Organization for Standardization (ISO) Clinical investigation of medical devices for human subjects - Good clinical practice 2011 (ISO 14155).
Note: Access to this document is restricted by copyright license. Contact Quality Assurance and Education for user access and more information.

Additionally, all clinical trials submitted to the Sunnybrook Research Ethics Board (REB) must comply with;
• 2nd Edition of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2010 (TCPS2), and
• The provisions of the Ontario Personal Health Information Protection Act (PHIPA) 2004.

Please contact Quality Assurance and Education if you require additional information.