Progressive Licensing Project

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Contact: Progressive Licensing

What is the Progressive Licensing Project?

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.

Why are you moving to this new system?

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:

• the limited number of participants in clinical trials;
• some adverse events are not detected during clinical trials because they happen so rarely;
• interactions with other drugs may not be detected; and
• longer-term effects of a drug may not be apparent at the time of marketing.

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.

What advantages will the Progressive Licensing system provide?

We anticipate that a Progressive Licensing approach will have many advantages, including:

• ongoing evaluation of the risks and benefits of a drug throughout its lifecycle, a change from the current focus of the system on testing a drug before it is marketed;
• new methods to generate evidence about the benefits and risks of drugs, and capacity in the regulatory system to consider new types of evidence in making licensing decisions;
• better capacity in the regulatory system to plan for, manage and communicate about risks as new information is obtained about a drug;
• improved access for consumers, patients and health professionals to current and accurate information about drugs throughout their lifecycle, so that they can make the most informed decisions possible;
• increased flexibility in the regulatory system to address particular medical needs or exceptional circumstances, such as rare diseases or compassionate use;
• better alignment of Canada's regulatory standards with international standards, recognizing that the development and monitoring of drugs is now happening on a global scale; and
• improved transparency about, and clear accountability for, decisions concerning the regulation of drugs.

For more information, please visit the Progressive Licensing Project Web site at:
www.healthcanada.gc.ca/progressive_licensing