Somers E, Kasparek M C, Pound J
Department of National Health and Welfare, Ottawa, Ontario, Canada.
Regul Toxicol Pharmacol. 1990 Dec;12(3 Pt 1):214-23. doi: 10.1016/s0273-2300(05)80059-5.
The legislative authority and framework for the regulatory control of drugs in Canada is outlined. The layered approach of the regulatory system is described, including the premarket review mechanism, postmarketing monitoring, and other requirements for specific drug categories. Changes in the Canadian regulatory approach to provide timely and effective drug evaluation are discussed, particularly increased international collaboration, regulatory accommodation for AIDS drugs, rationalized policies for traditional medicines, and the concept of risk/benefit analysis.
概述了加拿大药品监管控制的立法权威和框架。描述了监管系统的分层方法，包括上市前审查机制、上市后监测以及针对特定药品类别的其他要求。讨论了加拿大监管方法的变化，以提供及时有效的药品评估，特别是加强国际合作、对艾滋病药物的监管调整、传统药物政策的合理化以及风险/效益分析的概念。
