Regulating for the 21st Century: A Blueprint for Renewing Canada's Health Products and Food Regulatory System

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The Case for Renewal

A broad and flexible regulatory toolkit would provide:

• Greater flexibility to respond to rapidly advancing science and technology
• Authority to monitor safety and effectiveness of marketed products
• Greater investigatory and compliance powers
• More adequate provisions to promote openness and transparency, while protecting privacy and commercial confidentiality

An integrated 'system' across the product lifecycle would result in:

• Canada's regulatory, health care, research and development systems working interdependently
• Clear roles and responsibilities and a reduction in gaps and overlaps
• Consistent use of regulatory access mechanisms by patients, physicians, provinces and territories
  • e.g. Special Access Program, Clinical Trials, Market Authorization

Sustainability requires adequate resources, capacity and processes

Need to reconsider the regulatory paradigm

• Health Canada's current regulatory paradigm may fall out-of-step with international best practices
• Point in time approach - not designed for 'real world' product lifecycle; challenges in assessing values and risks.
• Imbalance between pre-market and post-market efforts for health products

Response to date

• Backlog cleared and performance targets met for drug reviews through investments in 2003 for the Therapeutics Access Strategy
  
  
• Strengthening of Canada's safety system for drugs, medical devices and other therapeutic products through investments in Budget 2005
  
  
• Responding to advances in science and technology
  • Canada's regulatory system for products of biotechnology
  • National safety standards and a new regulatory framework for cells, tissues and organs
    
    
• Improving transparency and openness
  • Public forums on pre- and post-market issues
  • Increased public information on marketed health products
  • Establishment of the Office of Paediatric Initiatives as a model for dealing with specific populations
    
    
• Improving international cooperation
  • Strengthened bilateral cooperation - U.S. FDA, Australia, EU, Switzerland, Singapore, China
  • North American cooperation: Security and Prosperity Partnership, Trilateral accord

Long-term strategy will contribute to federal policy objectives and is strongly linked to FPT initiatives for pharmaceuticals, other health products and food

Blueprint Summary

Objectives:

1. Life cycle approach
2. Interventions proportional to risk
3. Modern approach to food safety and nutrition
4. Make best use of all types of evidence
5. Pro-active and enabling regulatory system
6. Special emphasis on specific populations
7. Transparency, openness and accountability
8. Partner in an integrated system

1. Product life cycle approach

Issue:

Health Canada has limited ability to obtain new safety and effectiveness information, as well as to monitor how products used, across the product lifecycle

Response:

A regulatory approach that recognizes health products have a "life cycle". Instead of discrete interventions at rigidly defined points, a life cycle approach will encompass all stages of product development and use.

Priorities for moving forward include:

• New legislative authorities to better manage the risks of products across their lifecycle;
• A "Progressive Licensing" regulatory framework for pharmaceuticals and biologics, based on sound science and risk management, that supports access to promising new therapies and the continuous monitoring and reassessment of potential safety, quality, efficacy and effectiveness concerns through out the product life cycle.
• Review of the Special Access Programme (SAP) and Clinical Trials Regulations
• Implementation of ICH guidance E2E for pharmacovigilance / risk management planning

2. Regulatory interventions proportional to risk

Issue:

Current patchwork of product categories and regulatory frameworks (incl. drugs, NHPs, cosmetics, food) creates inefficiencies, including lack of clarity and administrative delays in product reviews, and inconsistent approaches across regulatory frameworks in terms of standards of evidence, health claims, and risk-based regulatory responses

Response:

A more transparent and consistent system of categorizing products and assessing their risks

Priorities for moving forward include:

• A more holistic system of product categorization implemented by new legislation, providing clear definitions, consistent regulatory approaches proportional to risk, and a flexible, efficient and predictable administrative process for resolving product categorization issues
• Review of the Natural Health Product Regulations and measures to improve regulatory performance

3. Modernizing the Regulatory Approach for Food Safety and Nutrition

Issue:

There is an opportunity to modernize the regulatory system for food safety and nutrition in order to improve system responsiveness to the needs of industry and the food safety and nutrition needs of Canadians.

Challenges of interdependent food issues and roles and responsibilities of stakeholders and FPT governments within a complex food system.

Response:

A Regulatory Modernization Strategy for Food and Nutrition which will enable development and maintenance of a food regulatory system that is flexible, risk-based, and provides timely responses to current and emerging food safety and nutrition issues.

Priorities for moving forward include:

• A review of sections of the Food and Drug Regulations that require pre-market safety assessment of foods and authorization of certain products (e.g., food additives, novel foods and infant formulae, etc.) before they can be offered for sale.
• New Regulatory Framework for Expanded Health Claims for Foods

4. Proactive and enabling regulatory system

Issue:

The regulatory system must keep pace with scientific discovery and be an enabling factor in health innovation; rather than an obstacle.

Response:

A pro-active regulatory system that engages stakeholders and helps influence the future

Priorities for moving forward include:

• Enhance dialogue with manufacturers during early stages of product development to flag potential evidence gaps for real-world effectiveness of drug products
• Establish a Regulatory Foresight Program and proactively develop or adapt regulatory guidances to support new product development and regulatory review
• Continued progress on establishing and meeting internationally-benchmarked performance targets for all regulated products

5. Make the best use of all types of evidence to strengthen oversight on safety and effectiveness

Issue:

Regulatory resources and tools are focused on pre-market assessment, not real-world monitoring of safety and therapeutic effectiveness.

Response:

Pro-actively generate, assess, disseminate, and respond to safety and effectiveness data for health products and food, using the regulatory system and research partnerships.

Priorities for moving forward include:

• National network of researchers to identify and investigate priority signals of safety and effectiveness (NPS Real-World Safety and Effectiveness initiative)
• Collaborate with key stakeholders to develop means for improved collection, analysis and dissemination of health product safety and effectiveness information;
• Strengthen capacity to report, analyze and manage medical incident data on a national basis, in collaboration with the Canadian Patient Safety Institute and other stakeholders

6. Special emphasis on specific populations

Issue:

Relatively few products have been designed or formulated specifically for use in specific populations (e.g. paediatrics, the elderly, and pregnant or nursing mothers). Population-specific information is necessary to guide product use.

Response:

Strengthened leadership on a range of health and safety issues affecting specific populations that pertain to food, nutrition and health products.

Priorities for moving forward include:

• Establish two advisory committees:
  • For policy advice - Paediatric Expert Advisory Committee (PEAC)
  • For scientific/technical advice - Paediatric Scientific Advisory Committee (PSAC)
    
    
• Explore incentives and requirements for industry to conduct trials for specific populations
  
  
• In the context of the Progressive Licensing Framework, develop evidence-based mechanisms to enable earlier access with improved safety to health products that address unmet health and/or therapeutic needs

7. Increased transparency, openness and accountability

Issue:

Current government approaches to product evaluation, which limit the involvement of stakeholders in the decision-making process, are no longer acceptable to Canadians, who seek opportunity to participate in decisions that may affect their health

Response:

A more open and transparent regulatory system where the involvement of patients, consumers, researchers and health professionals contributes to better overall quality of regulatory decision-making.

Priorities for moving forward include:

• Continued progress on making information on the basis of regulatory decisions and the risks and benefits of products available to the public
• Implementation of the Policy on Public Input into the Review of Health Products
• Registration and Disclosure of Clinical Trials

8. Partner in an integrated system

Issue:

The R&D and innovation, regulatory and healthcare systems often work independently from each other.

Response:

Health Canada will work to better synchronize the regulatory system with health system and innovation system objectives, policies and practices.

Priorities for moving forward include:

• Improve communication and partnership between Health Canada and the Common Drug Review, including information sharing and joint discussions with industry on validation of surrogate endpoints and requirements for post-market studies
• Expand partnerships with CIHR and other national and international research organizations (e.g., research on unmet health and therapeutic needs, biomarkers, vulnerable populations, generation and assessment of real-world safety and effectiveness evidence)
• Align the regulatory system with international best practices and harmonization initiatives
• Continue to link with FPT initiatives (National Pharmaceutical Strategy, food safety)

Critical Success Factors

Delivering on the vision and objectives will require:

1. A 21^st Century Toolkit: new legislation and regulatory frameworks and instruments
   • Legislation Renewal - overarching legislation for Health Canada
   • Blueprint for Renewal - regulatory modernization for HPFB
2. A sustainable, high performance, science-based organization: continued investments in staff and infrastructure
3. Utilization of international best practices for regulatory processes and risk management practices
4. Strategic international regulatory cooperation
5. Enhanced partnerships and stakeholder involvement

Next steps

Fall 2006 / Winter 2007

• Official Launch of a Blueprint discussion paper to all stakeholders and the public on October 16, 2006, as well as an e-consultation (October 26, 2006)
• Targeted consultations, including:
  • Progressive licensing framework; Food regulatory modernization; proposed regulatory framework for expanded food-related health claims; Review of the Natural Health Product Regulations; etc.

2007 and beyond

• Implementation of new program initiatives
• New legislation
• New fee structures for external charging
• New regulatory framework for expanded health claims for foods; improved pre-market regulatory processes for food additives; implementation of the Progressive Licencing Framework; Amendments to Natural Health Product Regulations

Visit:

http://www.healthcanada.gc.ca/hpfb-blueprint
for more information and to participate in our e-consultation.