Health Canada says a growing backlog of generic drug applications is principally due to a sharp increase in submissions.Cole Burston/The Globe and Mail
Health Canada is taking longer to assess generic drug applications from manufacturers, with the backlog of submissions doubling in the past year, new government data show.
The delays mean Canadian patients, as well as public and private insurers, are waiting longer to access cheaper pharmaceuticals, although the department said the backlog is principally due to a sharp increase in the number of generic drug submissions.
Health Canada met its target of assessing a generic drug submission within 180 days for 72 per cent of reviews in the 2025-26 fiscal year, according to department figures.
That was down from data The Globe and Mail reported on last summer, which showed the regulator was on time for 84 per cent of reviews in 2024-25 – which was itself a decrease from a 100-per-cent success rate in multiple recent years.
The backlog of submissions stood at 250 in June, up from 117 last September.
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Jim Keon, president of the Canadian Generic Pharmaceutical Association, said the delays are making it difficult and more expensive for manufacturers to arrange their supply chains and plan for patient support programs, since the timing of when they can launch products is unclear.
“It just makes it impossible to plan in any concrete way,” Mr. Keon said.
Generic manufacturers that want to sell their products in Canada must submit a dossier to Health Canada demonstrating that the products are bioequivalent, which means they work inside the body the same way as the branded drugs they mimic.
The department said the backlog is because of an “unprecedented” increase in the volume and complexity of generic drug applications, and that it is taking steps to improve its processing time.
Spokesperson Marie-Pier Burelle said Health Canada received 1,052 submissions in 2025-26, a 55-per-cent increase compared with the previous five-year average.
“Submissions are generally more complex and require more hours of scientific review to ensure the regulatory requirements for safety, efficacy, and quality are met,” Ms. Burelle said in an e-mail.
She said the department is currently issuing an average of 42 decisions a month, up from 33 a month five years ago.
A recent white paper from IQVIA, a pharmaceutical analytics company, said Canada is experiencing a pronounced wave of drug patent expirations, with 180 drugs representing $10-billion in annual sales losing their legal protections between 2026 and 2030. It highlighted coming patent expirations for the popular arthritis drug Stelara and Eylea, which treats vision impairment.
Mr. Keon said the industry supports Health Canada prioritizing certain applications as one way to deal with periods of high submission volumes. For example, the regulator could prioritize applications for drugs facing shortages or where there is not already a generic option on the market.
Health Canada said recently it will launch a pilot project to prioritize generic drugs made in Canada.
Mr. Keon said the industry’s main request is that Health Canada increase its review staff so they can handle the greater workload.
He noted manufacturers pay a fee with each application, which this year reached $71,953 for the most common generic submission type. Health Canada must refund a quarter of the fee if it does not issue a decision within its 180-day target.
The department has told generics makers and the association in meetings in the past year that it would hire 40 additional review staff, which fell short of the industry’s suggestion of 100 new staff. As of June, Health Canada said 12 new staff had been hired on two-year terms.
Mr. Keon said the federal government has kept pledging to improve its review process, but hasn’t made progress yet. “They’re acknowledging the issue, but they’re not seriously addressing it,” he said.
Generic drug prices in Canada are set out in an agreement between the CGPA and public health plans. When the first generic version of an off-patent drug is launched, it is priced at 75 per cent or 85 per cent of the brand-name list price. That eventually falls to 25 per cent or 35 per cent once three or more generic versions are on the market, with the price depending on the type of drug.
The pricing agreement was renewed for another two years in June.