Pharmaceutical Regulation in Canada

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.