Should Health Canada Use Reports From Foreign Regulators to Approve New Drugs?

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.