Toronto, November 5, 2025 – The following is a statement from Jim Keon, President of the Canadian Generic Pharmaceutical Association (CGPA) and Biosimilars Canada, regarding the federal budget tabled on November 4, 2025:
“Canada’s generic pharmaceutical manufacturers are a key part of Canada’s national infrastructure and are a strategic asset for our country, supporting Canada’s health security interests and bolstering our country’s economic interests through extensive life sciences investments, domestic manufacturing, and exports.
The Canadian Generic Pharmaceutical Association welcomes measures in Budget 2025 to support domestic life sciences and manufacturing investments, including lowering the marginal effective tax rate, immediate and accelerated capital investment write-offs, and enhancing the Scientific Research and Experimental Development (SR&ED) tax incentives.
Budget 2025 did not provide the resources Health Canada urgently needs to address its growing backlog of generic and biosimilar drug submissions. There are now more than 500 generic submissions under review with more than 100 of them backlogged. 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.
Drug reviews are a core Health Canada regulatory program and require increased and sustained resources to return to predictable operations and eliminate the backlog. Drug reviews are cost-recovered, with industry covering 75 per cent of the cost. At the current pace, even with planned red tape reduction initiatives, it will take years for Health Canada to return to on-time submission review performance and eliminate the backlog.
The CGPA and its member companies remain committed to working collaboratively with the federal government and Health Canada to restore timely drug review processes, and ensure Canadians have access to affordable, quality-assured medicines. We encourage Health Canada to provide a target date for when Canadians can expect the drug submission backlog to be eliminated and predictable drug review operations to resume.”