Technical Discussions on Regulatory Modernization for Therapeutic Products

Building on the success and progress of the Progressive Licensing Project for drugs, Health Canada hosted a series of technical discussions with stakeholders on regulatory modernization for therapeutic products (drugs and medical devices) to test and validate proposed activities related to the regulation a product throughout its lifecycle.

Dates

The agenda for these sessions followed the regulatory lifecycle of market authorization from pre-filing meetings, through application requirements, authorizations, and post-market activities, as well as compliance and enforcement activities.

  • Session 1 - October 27-28, 2010
  • Session 2 - November 30-December 1, 2010
  • Session 3 - January 19-21, 2011
Objectives

This initial consultation took the form of technical discussions and was intended to advance the modernization of the federal regulatory framework for therapeutic products. These discussions provided an invaluable opportunity for Health Canada to gain an understanding about the practical effects of potential amendments to the Food and Drug Regulations and Medical Devices Regulations.

Format

Seven days of discussions covered the regulatory lifecycle, including specific areas such as orphan drugs, access in exceptional circumstances, and advertising. Sessions focused on areas where substantial changes are anticipated to the existing regulatory structure.

After introduction of the topic, each "mock regulatory framework" was discussed by Health Canada regulatory staff and industry representatives to model how the proposed framework would function. After this discussion, other participants had the opportunity to comment on the mock frameworks and the discussion they had heard between the regulator and regulatee.

Participants

Participants were selected to represent the perspective of the regulator, industry, health professionals, consumer and patient groups, academics, international partners and other government departments.

Technical Discussion Documents

Each technical discussion document includes a general overview of the topic and objectives, provides proposed legislative authorities from the former Bill C-51 and elaborates a mock regulatory framework under these proposed authorities.  To request any of these documents, please contact us.

Summary of Feedback Received

Session 1 - October 27-28, 2010

Market Authorization & Access

  • Pre-submission Meetings and Market Authorization - General Requirements
  • Access Issues (Regulatory Frameworks for Drug Shortages, Discontinuances, Special Access Program and Drugs for Rare Diseases)

Market Authorization - Requirements By Product Line

  • Prescription Pharmaceuticals
  • Generic Pharmaceuticals
  • Non-prescription Pharmaceuticals
  • Biologics
  • Subsequent Entry Biologics
  • Medical Devices

Session 2 - November 30-December 1, 2011

Market Authorization and Post Authorization Requirements

  • Market Authorizations - Conditions & Content
  • Market Authorizations - Amendments

Post Authorization Activities

  • Public Register
  • Requiring Information/Label Changes
  • Requiring Tests/Studies

Session 3 - January 19-21, 2011

Post Authorization Activities and Combination Products

  • Requesting Benefit /Risk Reassessment, Establishing Advisory Committees
  • Market Authorization Suspension, Revocation
  • Combination Products

Information Requirements

  • Mandatory Reporting
  • Labelling
  • Advertising

Compliance and Enforcement

  • Inspection: A Graduated Approach to Establishment Licensing
  • Importation, Importation for Exportation, and Exportation
  • Anti-Counterfeiting and Deception
  • Recall, Stop Sale, and Corrective Actions

Summary of Feedback Received

Participants were generally supportive of the forum for discussion and the opportunity to engage and comment on the proposals.  Proposals were well received and generated valuable discussions and insights.   

Next Steps

The feedback received from these sessions will inform future development of regulations, including the implementation of the Regulatory Roadmap for Health Products and Food.

Health Canada will continue to engage stakeholders, international partners and the public. This work will proceed through the Canada Gazette process, where all parties will have the opportunity to consider and comment on proposed regulations.

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