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2006 November Report of the Auditor General of Canada

November 2006 Report—Chapter 8

Exhibit 8.2—Regulatory programs audited

Product Safety. The mandate of the Product Safety program is to identify, assess, and manage the health and safety risks to Canadians associated with

  • consumer products,
  • hazardous workplace materials,
  • cosmetics,
  • new chemical substances,
  • products of biotechnology,
  • radiation produced by radiation-emitting devices,
  • environmental noise, and
  • solar UV radiation.

The program has responsibilities under several acts and regulations, including the Hazardous Products Act, and had a budget of $17.8 million in 2003–04 and $18.7 million in 2004–05.

Drug Products. According to Health Canada, the Drug Products program maximizes the safety of marketed human drug products through its regulations. The program is delivered by three directorates in the HPFB (Exhibit 8.3).

  • The Therapeutic Products Directorate provides pre-market approval of pharmaceutical drugs offered for sale in Canada, ensuring that they are safe, effective, and of high quality.
  • The Marketed Health Products Directorate conducts post-market surveillance of prescription and over-the-counter drugs and other health products for their safety and therapeutic effectiveness.
  • The HPFB Inspectorate delivers a national compliance and enforcement program such, as inspections of manufacturers and product investigations for all health products under the Branch's mandate, including drugs for humans.

The Drug Products program had a budget of $51.8 million in 2003–04 and $50.6 million in 2004–05.

Medical Devices. The goal of the Medical Devices program is to ensure, to the extent possible, that the public has timely access to safe, effective, and quality devices. It also contributes to the continued protection of the public by informing health professionals and the public of any safety concerns on a timely basis. Like the Drug Products program, the Medical Devices program is delivered jointly by the Therapeutic Products Directorate, the Marketed Health Products Directorate, and the HPFB Inspectorate, which apply the Medical Devices Regulations. The program budget was $8.8 million in 2003–04 and $11.4 million in 2004–05.