Consultation

Health Canada's approach to the development of the new drug licensing framework has included deliberate early engagement with other decision makers, informing them of the initiative and seeking their input. The goal is to have an ongoing approach to consultations throughout development of the framework in order to build a modern and progressive system of drug regulation that will meet the needs of Canadians.

Results of Consultations

Stakeholder and Citizen Judgement of a New Canadian Drug Regulatory Framework

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

Progressive Licensing Framework Development Workshop

A large group of stakeholders from all affected groups was invited to a workshop on core values, entitled Progressive Licensing Framework Development Workshop and held on November 27-28, 2006. Representatives of the provincial governments, the industry, patient and consumer groups, as well as healthcare practitioners and academia, met to explore the values important to a new drug licensing framework.

The "open concept" workshop encouraged the participants to bring their own issues forward for discussion. As a result of their work during the workshop, participants identified seven key priorities and made recommendations that will guide the next phase of the Project. See the workshop Discussion Reports and the Recommendation Reports.

Mock Framework Exercises

Five days of meetings were held on May 28-30 and June 11-12, 2007 to explore and test a mock framework with all sectors of the healthcare system, from primary users of the regulations to those impacted by the decisions taken by Health Canada. The meetings covered the entire life-cycle of regulations: the pre-market development and planning; the licensing decision and entry on to the market; and the post-licensing period when drugs are being used by patients and consumers.

Discussions at the meetings were facilitated between Health Canada, industry representatives, provincial representatives, academics, consumer representatives, health care professionals and patients. These meetings were designed to resemble the practical discussions held between companies and reviewers within meetings relating to drug submissions in the course of drug review in the current regulatory framework, but while being observed by other stakeholders who were then given the opportunity to voice their perspectives. Following these discussions, a plenary session was held to conclude the sessions during which all participants were given the opportunity to participate. The Framework Exercises were intended to provide the Progressive Licensing Project practical input to arrive at a more detailed articulation of the framework. See the Mock Framework Exercises Summary.

Pharmaceutical Quality Workshop

A one-day workshop was held on June 28, 2007 with participants from industry, provincial governments and Health Canada to discuss pharmaceutical product quality regulation (including biologics) related to the development of a Progressive Licensing Framework.

A concept paper providing an overview of the quality component of the Progressive Licensing Project, along with four discussion papers further outlining and structuring the discussion topics for the workshop were sent to the participants prior to the meeting. Participants had the opportunity to comment on the following topics:

• Topic 1: Regulatory implications of a more science- and risk-based approach throughout the product life-cycle
  
  
• Topic 2: Establishing equivalence/comparability of new and existing products
  
  
• Topic 3: An Enhanced Regulatory Program for Product Quality Review and Inspections
  
  
• Topic 4: Quality implications of the increasingly international dimension of the pharmaceutical industry]

Stakeholders may still provide feedback on these topics by submitting comments directly to the Progressive Licensing Project through their dedicated e-mail address: progressive_licensing@hc-sc.gc.ca.

The Pharmaceutical Quality Workshop was meant to introduce issues and support the initial stages of discussion respecting the "quality component" of the Progressive Licensing Framework. A workshop summary report will be available shortly.

Contact information for the Progressive Licensing Project.