Maher Maurica
Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada.
J Popul Ther Clin Pharmacol. 2010 Fall;17(3):e341-8. Epub 2010 Oct 26.
This presentation is intended to show how the work coming from scientists, physicians, and other healthcare professionals is incorporated into the regulatory assessment of therapeutic products in Canada. One of the primary objectives within the regulatory environment is to provide information back to healthcare professionals and patients in order to help them make informed decisions. The current regulatory system for health products in Canada and why it needs modernization is addressed; a "lifecycle approach" to the regulation of health products is presented; the Food and Consumer Safety Action Plan and Bill C-51, a bill to amend the Food and Drugs Act is reviewed; and the challenges and opportunities for Canada and its fellow regulators are examined.
本报告旨在展示来自科学家、医生及其他医疗保健专业人员的工作成果是如何纳入加拿大治疗产品的监管评估中的。监管环境的主要目标之一是向医疗保健专业人员和患者反馈信息，以帮助他们做出明智的决策。报告讨论了加拿大目前的健康产品监管体系及其需要现代化的原因；介绍了健康产品监管的“生命周期方法”；回顾了《食品和消费者安全行动计划》以及旨在修订《食品和药品法》的C-51法案；并探讨了加拿大及其监管同行面临的挑战和机遇。
