Regulations, Guidelines & Important Links
Quality Assurance for Clinical Trials
Health Canada Regulations and Guidance
- Guidance for Clinical Trial Sponsors: Clinical Trial Application
- Food and Drug Regulations, Division 5
- Medical Device Regulations, Part 3
- Natural Health Products, Part 4
- Post-Authorization Requirements
- Health Canada Guidance for Records Related to Clinical Trials
- Notice: Applications for Medical Device Investigational Testing Authorizations – Changes to the Timing of Research Ethics Board (REB) Approval
- Applications for Medical Device Investigational Testing Authorizations Guidance Document
- Classification of Observations Made in the Conduct of Inspections of Clinical Trials
- Guidance Document: Part C, Division 5 of the Food and Drug Regulations
- Notice: Period reduced for keeping clinical trial records for drugs and natural health products