Health Canada is the Canadian federal public health agency. The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food. Three groups within HPFB, the Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), and the Veterinary Drugs Directorate (VDD) are responsible for the regulation of drugs and biologics for human and animal use. Medical Devices are reviewed and approved by the Medical Devices Bureau of the Therapeutic Products Directorate (TPD). The review procedures for medical devices in Canada are similar to those in the US, with different requirements for Class 1, 2, and 3 devices.
Companies wishing to obtain market approval in Canada submit a "New Drug Submission" to the HPFB. This submission is similar to a New Drug Application (NDA) in the US; it contains information and data about the drug's safety, effectiveness and quality from preclinical and clinical studies. In addition, the company submits details regarding manufacturing, packaging and labeling details. HPFB reviews the data, sometimes with the assistance of external consultants and advisory committees. If the HPFB concludes that the potential benefits outweigh the risks and that the risks can be mitigated, the drug is receives a Notice of Compliance (NOC), and a Drug Identification Number (DIN) which permits the sponsor to market the drug in Canada.
The Canadian HPFB issues Guidance documents to provide assistance to industry on how to comply with governing statutes and regulations. As a member of the International Council on Harmonisation most of these Guidances, Canada is committed to the adoption and implementation of ICH guidances and standards. In addition, Canada and the United States created the Canada-United States Regulatory Cooperation Council (RCC)in February 2011 to minimize the regulatory differences between the two countries when possible.
The Marketed Health Products Directorate (MHPD) of the HPFB is responsible for post-marketing safety and effectiveness monitoring, regulation of advertising activities, and risk communications for all regulated marketed health products. And the the Natural and Non-prescription Health Products Directorate (NNHPD) regulates natural health products for sale in Canada.