Initial Development

Setting the foundations for change, in 2006 the Department communicated its intent to adopt a "lifecycle approach" for the regulation of drugs.

A lifecycle approach means that products would be rigorously and appropriately assessed for quality, benefits, harms and uncertainties both before and after they enter the general market.

Lifecycle Approach Model
  • 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.

Lifecycle Approach Model

Health Canada initiated the Progressive Licensing Project to develop a drug regulatory system for the future that incorporates the lifecycle model. The Project was an initiative of the Blueprint for Renewal, a long-term policy framework that has helped inform the development and implementation of a plan to improve the drug regulatory system. This initial work forms the basis for how Health Canada will be approaching the regulation of health products and food.

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