Drug regulation--the Canadian approach.

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.