Risk Based Regulations for Natural Health Products
Through Canada's product regulatory system, government plays a lead and essential role in protecting the health and safety of Canadians. Citizens have high standards and expectations, both for the products they receive, and the government that regulates those products. However, unprecedented scientific advances and the growing economic importance of international trade are increasingly challenging the system. Canada’s regulatory system is founded upon exclusive product category definitions (food, drug, medical device, and recently natural health products) and their appropriate risk-management frameworks. However, new advances in science and technology are fuelling a significant increase in products that combine or move across existing regulatory product definitions and thus current regulatory approaches are becoming increasingly ambiguous or inadequate.
Four combination product were selected for this project (device-drug, device-NHP, NHP-drug, and NHP-food) because of their safety and efficacy issues, increasing prevalence in the market, exclusion from existing regulatory frameworks, and their innovative science, technological, and clinical applications. These qualities make them unique regulatory challenges, and in each case, the development of new definitions and policy frameworks will require the involvement and cooperation of a wide range of stakeholders. Four jurisdictions were chosen for assessment, the United States, Australia, EU, and Japan. These jurisdictions generally follow one of two approaches for risk assessment of new health products: risk-based classification rules or a product or panel based approach.The research objectives are to:
- Carry out a comprehensive analysis of existing regulatory policies and other relevant information for the four selected combination product sectors across the four regulatory jurisdictions.
- Execute a series of survey-interviews with key regulatory stakeholders to learn how the regulations under study are functioning in reality.
- Study what new relevant regulations may be under development in the four study jurisdictions.
- Further understand the "regulatory fate" of combination products, targeted products that received approval in most or all of the study jurisdictions, and products that did not.
- Carry out a SWOT (strengths, weaknesses, opportunities, threats) analysis on the various research phases.