Canadian FDA – Health Canada

Friday, 27 August 2010 08:46 by maxx

Americans are very familiar with the United States Food and Drug Administration or FDA. In the United States, the FDA is the regulatory body charged with protecting the public health via regulations concerning food and drug safety, medical devices and biological products, cosmetics, and radiation emitting products. The FDA controls how new medications are studied in humans and when they are allowed to be sold to the public. New prescription medications must meet strict FDA guidelines for development and dispensing. Further requirements necessitate the availability of accurate scientific information so that consumers can make educated and informed decisions. The Canadian FDA equivalent is Health Canada.

Health Canada, the Canadian FDA, is charged with similar responsibilities in terms of public health. Their role is to ensure Canadians have effective yet safe medications and health products. They must weigh the potential benefits to public health against potential risks, keeping public safety the primary focus. They are an integral part of the system of government, healthcare, patient advocacy groups, pharmaceutical companies, and consumers who each have a decided interest in the issues related to public health. Health Canada must devise regulatory systems that take into account all of the stakeholders.

Just as American consumers put their trust in the FDA, Canadian consumers also rely on Health Canada to protect them and their continued good health. Health Canada does this by enforcing regulations on drug development, medical devices, natural health products, health care product advertising, and pharmaceutical dispensing. They advocate consumer education and provide a clearinghouse of scientific information intended to further educate the public about issues in the healthcare industry. Such efforts include reporting of side effects, advisories, warnings, and recalls. Additionally, publishing regulatory requirements for advertising as well as research and development helps consumers understand what their responsibilities are as well as the responsibilities of companies and manufacturers.

Health Canada, as the Canadian FDA equivalent, receives funding from the Canadian government in addition to collecting fees from healthcare manufacturers and pharmaceutical companies to cover premarket reviews and post-market surveillance. Additionally, The Cost Recovery Initiative developed by The Health Products and Food Branch of Health Canada seeks to update and modernize cost recovery so that their organization has a financially sustainable future in which they may continue to provide maximum protection for the public health. This initiative seeks to modernize the regulation, licensing, premarket review, and post-market surveillance fee systems currently in place.