This study was undertaken to compare decisions about medicines innovation made by two Canadian organizations, the Therapeutic Products Directorate (TPD) and the Human Drug Advisory Panel (HDAP), with those made by similar organizations in other countries.

Although international medicines regulators adopt a common system to assess the safety and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the much larger post-market experience to follow. Adverse drug reactions contribute to more than 100,000 deaths in the United...