Pharmaceutical Regulation in Canada

Document Type

Book Chapter

Publication Date



Pharmaceutical Industry, Health Canada, Regulation, Clinical Research


Despite the near daily media attention paid to the safety, effectiveness and cost of pharmaceutical drugs, the regulation of drug products remains a mystifying area of Canadian law. The primary piece of governing legislation, now called the Food and Drugs Act, has been in force for well over a century but has seldom been the subject of judicial interpretation. Rather, the regulation of pharmaceuticals has largely occurred through an ever-evolving set of highly technical regulations, as well as a complicated set of guidances, policies and practices developed by Canada's drug regulator, Health Canada. This continuous and technical process of "bureaucratic law-making" does not, according to the regulator, carry the force of law. However, identifying and navigating Health Canada's policies and practices is key to understanding how pharmaceuticals are in fact regulated.