Life cycle description for product vigilance and benefit-risk management beginning at the product discovery stage.

• Product Discovery
• Clinical Trial Review
  • Pre-clinical Studies
  • Pre-submission Meeting
  • Clinical Trials
• Submission Review
  • Pre-submission Meeting
  • Product Submission
• Monitoring and Intervention
  • Authorization
  • Early Post-market Period
  • Integration of New Information
  • re-evaluation of authorization and commitments which could result in either
    • Removal of Product or
    • Evaluation of Product and Knowledge

Industry Activities include:

• Pre-clinical Studies
• Pre-submission Meeting
• Clinical Trials
• Pre-submission Meeting
• Product Submission
• Authorization
• Early Post-market Period
• Integration of New Information
• re-evaluation of authorization and commitments which could result in either
  • Removal of Product or
  • Evaluation of Product and Knowledge

Health Canada activities include:

• Clinical Trial Review
• Submission Review
• Monitoring and Intervention

Product Vigilance and Benefit-Risk Management activities are undertaken by Health Canada, Industry, Health professional and the public.