A new Health Canada order could expedite drug approvals in Canada by enabling reliance on decisions or documents provided by certain foreign regulatory authorities.
In a news release shared on Wednesday, the federal health department stated that this approach would reduce “unnecessary duplication” while maintaining national requirements for safety, efficacy and quality.
Officials will begin applying the approach to drugs for pediatric use and veterinary drugs, the release added.
The department is also seeking feedback on a proposed approach to prioritize the review of certain drug submissions that involve Canadian manufacturing.
“Supporting Canada’s generic pharmaceutical and life sciences sector will play a key role in enhancing the security of the drug supply and preventing harmful shortages that could negatively impact the health of Canadians,” the release reads.
Over the last three months, the federal department has approved 537 new drugs and medical devices, it added.
It is also the first G7 country to approve three generic versions of semaglutide, the release reads. Semaglutide is a pharmaceutical ingredient used in drugs for diabetes management and weight loss, like Ozempic.
While the order does represent a step towards reducing red tape in approving necessary drugs in Canada, one expert says critics of the country’s previous drug approval process may be “overblowing” the situation.
Joel Lexchin, professor emeritus at York University Faculty of Health, stated in a commentary earlier this year that Health Canada has been shown to approve at least 70 per cent of drugs approved by its U.S. counterpart, contrary to claims that a much lower percentage makes it past the review processes.
“For cancer drugs, that figure is even higher,” he added in the piece published by the Canadian Centre for Policy Alternatives in March.
Criticisms include that of the Canadian Organization for Rare Disorder, which states that only 60 per cent of treatments for rare disorders make it into Canada and most get approved up to six years later than in the U.S.
