2011 Fall Report of the Auditor General of Canada
Exhibit 4.1—Regulatory process for drugs in Canada
The exhibit shows the steps in the regulatory process for drugs in Canada, from pre-market to post-market. The pre-market part of the process starts with pre-clinical studies. The steps are
- Pre-clinical studies
- Clinical trials
- Regulatory product submission
- Submission review
- Market authorization decision
- Public access
- Surveillance, inspection, and investigation
The post-market part of the process begins with surveillance, inspection, and investigation when a drug has been made accessible to the public.
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