Update: In December, a consultation was launched on the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs. The Ministerial Reliance Order came into force on July 15, 2026.
Update: Consultations are also underway for other areas of Health Canada’s red tape review, including modernizing the clinical trial framework (open until April 19, 2026). Phase II amendments to the Medical Devices Regulations regarding medical device establishment licences will come into force December 14, 2026.
In July 2025, the Government of Canada launched a “Red Tape Review” across all federal departments to modernize regulatory frameworks and support economic growth. In this context, Health Canada and the Public Health Agency of Canada issued a Report on Red Tape Reduction, which identifies many ongoing and future initiatives, organized into five themes:
- International alignment and reduction of trade barriers;
- Improving client experience and service delivery;
- Risk-based regulating;
- Streamlining regulations, simplifying rules and enhancing flexibility; and
- Enabling new products and technologies
Increasing access to drugs through international collaboration, alignment and reliance
As one key initiative, Health Canada aims to increase international collaboration, alignment and reliance to facilitate access to needed drugs. To this end, Health Canada plans to advance an Order under the precision regulating authorities under the Food and Drugs Act in 2026 to expand its reliance on authorizations by comparable foreign regulatory authorities to satisfy regulatory requirements for certain classes of products. The proposed Order would also increase data, information and work-sharing with international regulatory partners. Additionally, Health Canada seeks to better align its approach to drug review with international regulators by soliciting additional data and clarifications during drug reviews, rather than relying on a single submission of all data at the beginning of the review process.
Health Canada expects that greater international collaboration, work-sharing and reliance with international regulatory partners will reduce the burden for industry, permit evaluation of more submissions without compromising safety, and accelerate approval of certain health products.
Other notable initiatives
The Report identifies additional initiatives, notably including:
- Expand mutual recognition agreements with other countries regarding good manufacturing practices (GMP) compliance programs.
- Amend the Medical Devices Regulations to support a risk-based approach and clarify medical device establishment licence requirements.
- Modernize drug establishment licensing by implementing flexible tools for corrective actions and restrictions, and a risk-based (not annual) cycle for assessment of health and safety evidence.
- Reduce red tape for natural health products and non-prescription drugs with a simple registration process for certain products and flexible risk-based monitoring.
- Modernize the framework for clinical trials through regulations and associated guidance.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance 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.