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2006 November Report of the Auditor General of Canada
November 2006 Report—Chapter 8
Exhibit 8.5—Examples of post-market compliance and enforcement activities considered by Drug Products and Medical Devices program managers to be insufficient
|
Compliance and enforcement activities |
Drug Products |
Medical Devices |
|---|---|---|
|
Conducting inspections of manufacturers of drug ingredients |
|
n/a |
|
Reviewing trends, surveillance, market surveys, and complaints on non-compliant products |
|
|
|
Sharing and coordinating information and expertise with other regulatory organizations (for example, Canada Border Services Agency) |
|
|
|
Inspecting the manufacturing practices of foreign sites and accompanying foreign inspectors at Canadian sites |
|
– |
|
Conducting investigations of clinical trials |
|
|
|
Conducting investigations of Internet pharmacies |
|
n/a |
|
Inspecting manufacturing practices and issuing licences |
|
n/a |
|
Investigating reports, complaints, and recalls of medical devices |
n/a |
|
Insufficient level of activity
– Not raised as a concern by Health Canada
n/a Not applicable
Sources: Health Canada's internal study, resource allocation documents, and interviews