Like a straight-A high schooler whose grades drop at university, Health Canada is struggling with an increased workload.
Driving the news: Health Canada is meant to issue rulings on new generic drugs within 180 days of receiving an application, but according to new data obtained by the Globe and Mail, the nation’s health regulator met this deadline 84% of the time last fiscal year. While that might sound okay, it’s down from 94% the year before, and 100% from years prior.
- What’s more, in 70% of cases, the ruling wasn’t issued until mere days before the deadline, with nearly three-quarters of those applications resulting in a rejection.
Why it’s happening: The missed deadlines are potentially tied to an increase in generic drug applications, which jumped by 43% between 2016 and 2025. This surge coincided with a 200% rise in submissions to change formulas for generic drugs already on the market.
Why it matters: Canada has the fourth-highest drug prices among developed nations. A 2024 survey found that 22% of Canadians split pills, missed doses, or didn’t fill prescriptions due to costs — timely approvals of generics can help save these patients money.
What’s next: Applications could spike further next year as Novo Nordisk’s patent for Ozempic expires. With drug makers like Sandoz Group promising an alternative that could be 70% cheaper, Canada’s 1 million-plus GLP-1 users will be waiting on approval news.—QH