Wednesday, September 23, 2026 On August 14, 2026 Health Canada released an updated guidance that replaces Guidance Document: Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100), version 3The update includes minor editorial revisions to French version No. 3. The English version of GUI-0100 remains unchanged; however, the English version number has been updated to align with the French version.A PDF version of the Guidance is also available on the Health Canada website: Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100) It applies to sponsors, researchers, and any parties involved in conducting clinical trials with drugs (pharmaceuticals, biologics, and radiopharmaceuticals) in human participants in Canada.
