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
Text description
- 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.
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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