Brief History of Drug Regulation in Canada

The federal oversight of food and drugs in Canada predates Confederation, but was initially confined to ensuring that food and drugs were not adulterated. The Proprietary or Patent Medicine Act (1909) was the first legislation to register medicines, which it limited to secret-formula, non-pharmacopoeial packaged medicines. The Act was the beginning of the protection of the public against drugs administered without medical supervision.

Following the establishment of a federal Department of Health in 1919, the Food and Drugs Act was introduced in 1920. By the late 1920s, Regulations developed under the Act established specific requirements for licensing drugs. The Minister of Health had the authority to cancel or suspend a licence for violations of the requirements.

A significant reworking of the Food and Drug Regulations did not begin until 1947, but it laid the foundation for the regulations in place today. By 1951, manufacturers were required to file new drug submissions prior to marketing their drugs. However, the regulations did not prevent the thalidomide tragedy of the early 1960s, which resulted in serious birth malformations and death to thousands of infants.

The thalidomide tragedy prompted a complete revision of the regulations to strengthen the Department's regulatory abilities. The revision marked the first appearance of the requirement for manufacturers to submit evidence of efficacy in seeking a Notice of Compliance.

The current system for the regulation of drugs in Canada focuses on pre-market activities and is characterized as point-in-time. A manufacturer can put its drug on the market once it has received a Notice of Compliance from Health Canada. The manufacturer must meet a number of obligations, but as long as the drug causes no adverse reactions or the manufacturer does not need to make changes to the drug, it may never be subject to review by Health Canada again. Medical and social trends, both domestic and international, are putting pressures on this system to evolve.

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