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Contact: Progressive Licensing
The goal of the Progressive Licensing Project is to develop a modern, integrated approach to the regulation of pharmaceuticals and biologics that can be implemented throughout the lifecycle of these drugs. The Progressive Licensing Project is an initiative under the Health Products and Food Branch's Blueprint for Renewal, a long-term policy framework for improving the regulatory system for health products and food.
Our current legislative and regulatory tools have served Canadians well, but need to be modernized to address current realities and emerging challenges. New technologies are fundamentally changing the nature of health products and how they are developed.
Although a new drug submission contains a great deal of information, our knowledge about how the drug affects the human body is still limited at that point in time for a number of reasons, including:
These limitations mean that the ongoing collection and analysis of information after a drug is marketed is critical. It is only after a drug is marketed that many more people will be exposed to the drug, and further important facts about the drug can be determined. Patient groups not included in the original clinical trials, such as children and the elderly, may be exposed to the drug and this may yield important information about how the drug affects those groups. Also, physicians may choose to prescribe a drug in ways not considered in the original authorization.
Because the information about a drug increases over time, our understanding of its benefits and risks can change. Progressive Licensing means that Health Canada would assess the benefits and risks of a product before and after it reaches the market, establishing a stable regulatory standard that reflects a lifecycle approach to drug regulation.
We anticipate that a Progressive Licensing approach will have many advantages, including:
For more information, please visit the Progressive Licensing Project Web site at: