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Health Canada's Approach to Achieve Regulatory Harmonization: An Update
Session Chair(s)
Agnes Klein, MD
Senior Medical Advisor
Health Canada, Canada
Health Canada has had a somewhat unique approach to regulating therapeutics. Over the years, Canada had interpreted the regulations in light of scientific advances, mainly because its regulations dated from the early 60's. Most recently, however, Canada has started to modernize its regulations, particularly in ensuring that the right authorities to regulate therapeutics with a life cycle approach were to be in place. In this session, the following will be highlighted: Bill C-17 dubbed Vanessa's Law, the current status of orphan drug regulations and the approached to be used in managing therapeutics postmarket. In all these areas, Canada has endeavored to be harmonized with international approaches. However, there are some unique features in how these elements are approached.
Learning Objective : Identify how different jurisdictions approach regulations to achieve the common goal of ensuring the safety, efficacy and quality of therapeutics; Describe a set of regulations that are integrated and regulate the full life cycle of a specific group of therapeutics; Discuss how guidelines can achieve the same goal within different regulatory regimes.
Speaker(s)
Advances and New Canadian Regulations
Agnes Klein, MD
Health Canada, Canada
Senior Medical Advisor
C-17: Protecting Canadians From Unsafe Drugs Act - Vanessa's Law
David Edwards, JD
Health Canada, Canada
Senior Counsel
Protecting Canadians from Unsafe Drugs Act (Vanessa's Law): Application in Orphan Drug for Rare Disease Regulatory Framework (ODRF)
Duc Vu, PhD
Health Canada, Canada
Director, Marketed Biologicals, Biotechnology, Natural Health Products HPD
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