October 15, 2026 | Ottawa, Ontario | Health Canada
Canadians expect timely access to safe and effective drugs and medical devices. Health Canada is providing a quarterly update on the steps the department is taking to make its regulatory processes more modern and efficient, while maintaining high standards for safety, efficacy, and quality.
From July 1 to September 30, 2026, Health Canada has taken a number of steps to improve access to the drugs and medical devices Canadians need. The department has authorized 16 new prescription drugs and 33 generic and biosimilar drugs. During this period, Health Canada also approved 540 new medical devices.
A growing number of increasingly complex drug submissions is putting pressure on the drug review process. To address this, Health Canada is prioritizing the review of certain generic drug submissions to provide better access to medicines in Canada, prevent and minimize disruptions to Canada’s drug supply, and make the generic drug review system more sustainable in the long term.
To help Canadians access promising new treatments sooner, Health Canada is also moving forward with the first phase of its clinical trials modernization efforts. This includes :
- Supporting faster implementation of modernized clinical trial requirements ahead of new regulations, which will modernize Canada’s clinical trial framework and help attract more clinical research to Canada.
- Providing information on clinical trials approved by Health Canada through a new clinical trials portal, to help patients find information about clinical trials that may help them and help researchers, health care providers and other stakeholders access information about ongoing trials.
- Making it easier for researchers to conduct pediatric standard-of-care studies through a new pilot project. This could generate better evidence leading to improved treatment outcomes for children, who are often prescribed drugs intended for adults off label (i.e. outside of their indicated use).
Health Canada is also working to get more medicines approved for children and youth to Canadians faster. Under the proposed approach, review times would be reduced by up to 40%, from 300 days to 180 days. Health Canada is currently consulting on the proposed changes until October 23, 2026. The department has already begun implementing shortened review timelines and welcomes additional ideas and comments on how to continue to improve on these efforts.
Finally, Health Canada is launching a new pilot for Access Consortium work-sharing submissions that will provide more flexibility during the review process and prevent delays. This will result in stronger alignment between international regulators and help bring products to the Canadian market faster. The Access Consortium is a coalition of international regulatory authorities that work together to promote greater regulatory collaboration and alignment, including joint reviews of new drug submissions.
Together, these changes are creating a faster, more efficient regulatory system that is improving access to medicines while maintaining Canada’s high standards for safety, efficacy and quality.
