On October 15, 2026, Health Canada provided its quarterly update summarizing steps it has taken “to make its regulatory processes more modern and efficient, while maintaining high standards for safety, efficacy, and quality.” The steps summarized include items we have previously reported on, including:
- Prioritization of certain generic drug submissions;
- Modernization of clinical trials;
- Accelerating pediatric drug approvals; and
- Pilot project for work-sharing on submissions within the Access Consortium.
As part of the quarterly update, Health Canada provided a background on drugs and medical devices authorized from July 1 to September 30, 2026. It approved 16 new drug submissions for new active substances (14 pharmaceuticals and 2 biologics) and 540 new medical devices, including 27 Class IV medical devices, as well as 30 generic drugs and 3 biosimilar drugs.
On October 14, 2026, the Patented Medicine Prices Review Board (PMPRB) published the 10th edition of its annual Meds Entry Watch report. The report looks at drug approvals in 2021-2025 by Health Canada, the United States FDA and the European Medicines Agency, as well as sales information on these drugs in Q4 2024.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.