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The regulation of drugs is undergoing rapid worldwide change in response to the advances in pharmaceutical sciences, drug development, and changes in public expectations. To ensure that Health Canada is capable of maintaining and enhancing its reputation as a science-based and reliable regulator, the Progressive Licensing Project was initiated to develop a drug regulatory system for the future.
The Progressive Licensing Project is an initiative of the Blueprint for Renewal, a long-term policy framework that will help inform the development and implementation of a plan to improve the drug regulatory system.
This Web site details the plan for developing a new framework, and provides an opportunity for discussion with Canadians regarding drug licensing. As development continues, the Web site will grow with the addition of more details about specific issues, results of stakeholder interaction, and ultimately a new proposed regulatory framework.
The following sections of the Web site provide material to enable stakeholders to develop an understanding of the current drug licensing system, explore specific issues, and provide comments on the proposed concepts of a new framework. In addition, a concept paper that articulates the project and its vision has been created.
- This section surveys the history of drug regulation in Canada, and the domestic and international context, and provides details of the project plan with an introduction to the main themes of a new framework.
- Current System
- This section presents the current drug approval process in Canada, using flowcharts to describe the different steps. It also provides links to important supporting documentation, such as guidance and policy documents.
- Progressive Licensing Model
- This section shows the transformation of the current point-in-time licensing system into the cyclical progressive licensing model. The section also discusses the main themes of a new framework, while nodes on the progressive licensing model link to discussion papers. Each discussion paper introduces a discrete issue, details some of the considerations, and provides a basis for comment by stakeholders.
- Discussion Papers
- Each discussion paper explores a discrete issue that has been identified as integral to the development of a new licensing system. They present some of the challenges that must be addressed by a modern drug licensing framework. The papers introduce the questions; they do not attempt to provide solutions, which will come as a result of the initial consultations and the project's development. The discussion papers have been grouped by their general topics. Hyperlinks to specific papers are also provided throughout the Web site, where relevant. Each paper offers an opportunity for stakeholders to submit feedback directly to Health Canada.
- Development and Implementation
- This section describes the elements of the project's development process: the project plan; the change management process; guidance documents and training programs; and results of consultations. This section will grow as the project moves forward, with more information added as milestones are reached.
For an overview of the Progressive Licensing Project, please consult our Fact Sheet.
Contact information for the Progressive Licensing Project.