Slower drug approval times do not improve patient safety.

Review and approval of new drugs takes significantly longer in Canada compared to the United States. A new study published in the Annals of Pharmacotherapy compares new drug approval times in Canada and the United States and examines whether faster, more efficient reviews have an impact on drug safety.

Drug approvals times in Canada are longer than in the U.S. for all drug categories, and for all review types (priority and standard). Over the past decade there have been about half as many drug withdrawals in Canada compared to the U.S. ( 2.0% versus 3.6%). But the difference in the number of withdrawals is not due to better scrutiny and vigilance through longer review times but rather because the delays in drug reviews in Canada “have provided an opportunity to observe actual market experience in other countries.”

One of the consequences of longer review times in Canada is that Canadian patients wait longer for the benefits that new drugs can provide. According to the study authors “The trade-off is that new drugs, including those for conditions for which current therapy has limited efficacy, take significantly longer to be approved in Canada and, hence, to be available to Canadians.”