Federal Budget Skips Health Canada Generic Backlog Fix: CGPA

Canada's 2025 federal budget did not include new resources for Health Canada to address a generic drug approval backlog, despite a Liberal election promise to speed up drug approvals, according to reporting by The Globe and Mail [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Budget omission draws industry criticism

Prime Minister Mark Carney's April election platform promised to speed up drug approvals in Canada, which have among the longest wait times in the developed world [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of]. The federal budget tabled in November did not mention the issue [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

The Canadian Generic Pharmaceutical Association said it was disappointed no new resources at Health Canada were being directed to the problem, especially as most of the work is paid for by industry fees [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of]. CGPA president Jim Keon said in a November statement that "every day of delay in approving these medicines costs the health care system millions and denies drug plans the savings needed to fund new treatments, which is not in the interests of Canadian taxpayers, employers, and patients" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

The CGPA stated more than 500 generic submissions were under review, of which more than 100 were backlogged [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Health Minister responds

Health Minister Marjorie Michel's office said they are working on the issue and see the importance of cutting red tape to get treatments to patients sooner and create a more attractive environment for businesses [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Spokesperson Guillaume Bertrand said "the approval process currently takes too long, with bureaucracy getting in the way of delivering essential medications to Canadians who need them" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Health Canada did not respond specifically to a question about semaglutide submissions but said generally the department is working to modernize drug-approval regulations and more complex submissions can take longer [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Backlog context and 180-day target

Health Canada has a target of responding to all generic submissions within 180 days but hit that target only 84 per cent of the time in the fiscal year that ended March 31 [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of]. In most of those cases where the target was hit, the applications were rejected within days of the 180-day deadline and then accepted after further review [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Sandoz Canada Inc. filed its semaglutide application in November 2024, and a year later the company is still answering questions from Health Canada about its submission [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of]. Michel Robidoux, general manager of Sandoz Canada, said "the road to get this drug approved is probably longer than expected" [Source: theglobeandmail.com/business/economy/article-health-canada-approval-backlog-expected-to-push-back-arrival-of].

Semaglutide approvals and queue

On April 28, 2026, Health Canada authorized the first generic semaglutide injection, filed by Dr. Reddy's Laboratories, as a generic version of Ozempic [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide]. Health Canada said it is currently reviewing eight other submissions for generic semaglutide by different companies and expects to make regulatory decisions on more of these submissions in the coming weeks and months [Source: canada.ca/en/health-canada/news/2026/04/canada-becomes-the-first-g7-country-to-approve-a-generic-version-of-semaglutide].

Obesity Canada's Scientific Director Dr. Sanjeev Sockalingam noted that fewer than 20 per cent of Canadians with private drug benefit plans have access to Health Canada-approved obesity treatment medications, suggesting lower-cost approved options should prompt governments, insurers, and employers to reconsider coverage [Source: obesitycanada.ca/news/health-canada-generic-semaglutide-approval].

Canadians tracking generic availability can monitor the generic semaglutide tracker or check the insurance coverage checker for plan updates. Brand competitors including Wegovy, Mounjaro, and Zepbound remain available through Canadian pharmacies. See our FAQ for more on regulatory timelines.

This article is for informational purposes only and does not constitute medical advice.