Description - Figure 1: Health Canada’s Current Health Product Review Process - Health Product Vigilance Framework

Health Canada's current health product review process:

• Pre-Clinical Studies
• Clinical Trial Authorization, which includes:
  • Clinical Trials
• Submission Review, which includes:
  • Regulatory Submission
  • Safety, Efficacy, and Quality Review
  • Market Authorization Decision
• Public Access
• Post-market, which includes:
  • Surveillance, Inspection, and Investigation
  • Post-market Changes

Health Canada has regulatory authority during the following stages of the process:

• Clinical Trial Application
• Submission Review
• Post-market