2011 Fall Report of the Auditor General of Canada

Fall 2011 Report—Chapter 4

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.