Progressive Licensing Model

The progressive licensing model would be based on sound science and risk management (discussion paper, Risk Management and Planning). It would support access to promising new drugs (see the discussion paper, Regulatory Options for Evaluating Promising Therapies) and the continuous monitoring of safety, quality, and efficacy (discussion papers, Pharmacovigilance and Therapeutic Effectiveness, to come)

Three Assumptions

The progressive licensing model is being developed on three assumptions:

1. Drugs can have positive and negative effects. The positive effects, known as benefits, happen when the drug works as intended to prevent, treat, or diagnose an illness. The negative effects, called risks, happen when a drug does not work as intended or it causes an adverse reaction.
2. Drugs have a life cycle (see the discussion paper, Drug Life-cycle Management Planning). They are conceived, developed, brought to market, and eventually withdrawn from the market or replaced by new therapies.
3. Knowledge and experience can be gained from every stage of a drug's life cycle.

A well-designed regulatory framework should support the collection, analysis, and communication of knowledge and experience about a drug throughout its life cycle so that it can be used wisely. A new regulatory framework would require new regulations and additional framework components, including new guidance documents, processes, and practices.

The following major themes have emerged for a new licensing model:

• Life-cycle Management
• Benefit-Risk Evaluation
• Good Planning
• Accountability

Contact information for the Progressive Licensing Project.