Abstract

Health Canada is consulting on whether to use reports from foreign regulators as the basis for approving new drugs. This Data Matters article looks at three metrics: the time gap between submission of new drug applications to the Food and Drug Administration (FDA) and Health Canada; the time gap between FDA and Health Canada approval of new drugs; and the proportion of FDA-approved new drugs that are also approved by Health Canada. This article argues that there is no convincing evidence that such a change is necessary. Health Canada should pause its plans for using foreign regulator reports until it can show that its initiative is necessary to improve the health of Canadians.