Development and Implementation

The development of the progressive licensing framework offers Health Canada a unique opportunity to take advantage of the present knowledge and experience of those who make decisions about drugs. The decision makers have their own sets of values, needs, perspectives, and knowledge, and Health Canada recognizes that all decision makers have valuable contributions to make to the creation of the framework. The development, review, and authorization for marketing, prescribing, and use of drugs is a serious undertaking that involves assessments of benefit and risk by all decision makers at each part of the drug life cycle. These decision makers include Health Canada, manufacturers, provinces and territories, healthcare professionals, caregivers, and patients.

For example, when Health Canada reviews a drug submission to reach a decision about whether a drug should be marketed, we conduct a benefit-risk assessment from a population-based perspective. We use the information in the drug submission to answer the question; "Will the benefits outweigh the risks of this drug for many people?" Prescribing health professionals ask a different question when conducting their benefit-risk assessment for an individual patient, "Will this drug benefit this particular patient, given this patient's specific needs?"

This section of the Progressive Licensing Project's Web site has five subsections:

• Project Plan and Timeline
• Change Management
• New Processes and Guidance Documents
• Training Programs
• Consultation

Contact information for the Progressive Licensing Project.