Project Plan and Timeline

The Progressive Licensing Project is following a defined and methodological approach to developing a new drug licensing framework. This approach applies to the regulations that will build the framework, as well as the operational processes and the infrastructure to support it.

Phase I: Information Gathering

During this phase, the Project team compiled and organized all documentation on the present drug regulation system in Canada, including legislation, regulations, policies, guidances, consultation reports, and policy issue analyses. Previous work regarding proposed changes to the present drug licensing system was also collected, along with documentation on regulatory regimes from the United States, the United Kingdom, Australia, New Zealand, Japan, and the European Union. Early consultation and engagement with stakeholders took place to help identify specific issues that should be addressed in a new framework.

An expert modelling session, entitled Stakeholder and Citizen Judgment of a New Canadian Drug Regulatory Framework, was held on July 19, 2006, with a small but diverse group of stakeholders.

Phase II: Analysis and Creation of a Proposal for a New Framework

The Project team has analyzed the documentation compiled from Phase I to assist it in the creation of a proposed new regulatory framework. As a result of this analysis, a concept paper was developed that presents the motives and main themes fundamental to a new drug licensing framework.

Phase III: Internal and External Consultations

During this phase an outline of the proposed progressive licensing framework was disseminated for consultation with internal and external stakeholders. The Project team used a variety of tools, including consultation sessions and this Web site. Many of the specific issues identified will be further analyzed by the Project team and the model will be further refined.

Phase IV: Building the Regulatory Framework

The Project team is currently completing a few engagement activities from Phase III and is moving towards Phase IV with the development of a Progressive Licensing Framework document. It will incorporate the feedback received from Phase III and elaborate the framework in detail.

Phase V: Introducing Regulations

A new regulatory framework will be built based on the core concepts identified for the project and the work with stakeholders. Proposed new regulations for the licensing of drugs will be published in the Canada Gazette, Part I, which will be followed by a consultation period. The public will have another opportunity to provide comments on the design of the framework.

During this phase the comments received from the Canada Gazette, Part I, process will be analyzed and considered, providing the basis for revisions to the proposed regulations. Once the regulations are revised, they will be published in the Canada Gazette, Part II which will signal that the regulations are effective and in force.

Contact information for the Progressive Licensing Project.