Like a student who’s behind on their readings, Health Canada is looking to copy some homework off of friends.
Driving the news: A new draft ministerial order laid out proposals to quicken drug approvals by relying on work already completed by trusted foreign regulators. These trusted regulators haven’t yet been named, and the changes would apply only to certain drug categories.
Health Canada could soon deem parts of a submission as already completed if the drug has been approved by a trusted regulator, take elements of in-progress reviews by another regulator for its own review, or conduct more joint reviews.
Why it matters: Health Canada’s drug approval process has been dinged for molasses-slow approval times compared to its peers, delaying market access for drugs that are more effective or less expensive.
This problem is particularly acute for generic drugs. A report from last year found that fewer generic approval rulings were completed on time in 2024 compared to 2023.
Yes, but: Critics are worried this could lead to a drop in Health Canada’s own due diligence. Some health experts also fret the U.S. Food and Drug Administration will be on the list of regulators, as the once-venerable body has been thrown into turmoil under the leadership of RFK Jr.
Plus: There’s also an argument to be made that the real issue isn’t approvals, but the time it takes for new drugs to receive coverage. On average, it takes a drug two-and-a-half years to get from approval to public reimbursement — the longest wait in the G7.—QH