Progressive Licensing
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.
- Background: 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.
Contact information for the Progressive Licensing Project.
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