Sandoz Canada highlighted five of its generic drugs that Health Canada has been reviewing since 2023, four of which would trigger a reduction in price. The company gets a lot of its drugs made at the Delpharm manufacturing facility in Boucherville.Andrej Ivanov/The Globe and Mail
Health Canada is taking longer to assess generic drug applications, lengthening the wait until the cheaper pharmaceuticals can come to market, new data show.
The federal regulator’s delays mean that it takes more time before patients are able to access some medications, and also that both public and private insurers may spend more on drugs before the less expensive alternatives become available.
Health Canada is supposed to issue rulings on new generics – which are copies of branded drugs whose patents have expired – within 180 days of accepting submissions. In the fiscal year that ended March 31, the regulator hit that target 84 per cent of the time, down from 94 per cent the year before and 100 per cent in three other recent years.
But the Canadian Generic Pharmaceutical Association (CGPA), which shared the internal Health Canada data with The Globe and Mail, says the delays are worse than they appear.
In 70 per cent of cases in 2024-25, Health Canada issued a ruling with a week or less to go before the deadline. In nearly three-quarters of those last-minute decisions, the regulator rejected the application and asked the company for more information, resetting the clock for a second review with no time frame and no financial consequences for Health Canada.
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The regulator meets its performance target as long as it issues a first approval or rejection within 180 days. If it misses that mark, it has to refund 25 per cent of a drugmaker’s application fee.
“Health Canada acknowledges they’re picking up submissions late,” said Jim Keon, president of the CGPA, which represents 17 companies. “They are short of resources. There’s a higher submission volume. The products are becoming more complex that they need to review, and they’ve had difficulty keeping up.”
Health Canada said in a statement to The Globe that, between 2016 and 2025, the regulator saw a 43-per-cent rise in generic drug applications and an increase of more than 200 per cent in submissions related to changes for generics already on the market.
“Alongside this growth in volume,” the statement says, “the complexity of submissions has also generally increased. This added complexity has led to a more than 30 per cent rise in the average number of review hours per submission over the past 5 years.”
Generic manufacturers that want to sell their products in this country have to submit a dossier to Health Canada demonstrating their knockoffs are bioequivalent, which means they work inside the body the same way as the branded drugs they mimic.
Michael Law, a pharmaceutical policy researcher and academic director of the Centre for Health Policy at the University of Calgary, said the regulator’s longer assessments could be partly the fault of manufacturers if they are filing incomplete applications.
“The idea that Health Canada is to ‘blame’ here rests on the assumption that all of these submissions are of the same level of quality,” he said by e-mail after reviewing the data shared by the CGPA. “If the average submission has been getting worse over time, however, then it might be the case that it does take a longer time to parse the data and determine the decision.”
Health Canada said in its statement that, in recent years, its reviewers have issued more negative decisions after the first review owing “to deficiencies related to safety, efficacy and quality.”
Mr. Keon and the CGPA said that wasn’t the case, and countered that Health Canada sometimes asks for impurity testing or bioequivalence studies that go beyond what regulators in the United States and Europe require.
Michel Robidoux, president and general manager of Sandoz, says Health Canada should do a better job of harmonizing standards with peer countries that authorize copies faster.Andrej Ivanov/The Globe and Mail
That might be fine if Health Canada flagged the shortcomings of an application early, said Michel Robidoux, president and general manager of the Canadian branch of Sandoz Group AG, the Swiss generics giant.
“I think the issue is, if you wait eight months to be told that, ‘Oh, your file is missing something,’ then you’ve lost eight months,” he said.
Either way, the data, which the CGPA said were presented at a meeting with Health Canada’s Pharmaceutical Drugs Directorate on June 23, show the regulator is issuing more first-round rejections now than in the past.
In 2019-20, Health Canada gave a thumbs-down to 49 per cent of generic applications during the first review. That figure fell to 42 per cent at the height of the pandemic in 2020-21, then rose to 70 per cent in 2023-24 and 73 per cent in 2024-25. Last year, 90 per cent of generic applications were ultimately approved.
Mr. Keon said some of the industry’s frustration was that when Health Canada increased fees starting in 2020, that came with a pledge to speed up processing times.
Fees for the most common type of new generic application hit $70,750 this year, up 39 per cent from 2020.
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The Canadian generics industry and the pan-Canadian Pharmaceutical Alliance, which negotiates drug prices on behalf of public drug plans, have agreed to a framework that pegs generic prices to a percentage of the sticker price of brand-name medications.
The lower prices are available to all payers, not just government drug plans.
Prices are set at 75 to 85 per cent of the brand price when there is only one generic on the market. If two copies are approved, the price falls to 50 per cent. If three or more enter the market, the price drops to 25 or 35 per cent, depending on the type of drug.
Approving cheaper generics can result in “huge savings for the public payers – so ultimately, the taxpayer – and huge savings for the private payers,” Mr. Robidoux of Sandoz said.
Sandoz highlighted five of its generic drugs that Health Canada has been reviewing since 2023, four of which would be the second or third entrant into the market, triggering a reduction in price.
One is sapropterin, an expensive drug for phenylketonuria, a rare inherited metabolic disorder. Another is the breast-cancer drug palbociclib.
If Health Canada can’t keep up with a rising volume of applications for complex generic drugs, Mr. Robidoux added, it should do a better job of harmonizing standards with peer countries that authorize copies faster.
“Why would a drug be approved in six months with the same submission documentation in Europe and lag approval in Canada?” he said.