Health Canada Opens Formal Consultations on Red Tape Reduction Initiatives to Improve Access to Drugs

OTTAWA, ON, Dec. 19, 2025 /CNW/ - Today, the Honourable Marjorie Michel, Minister of Health, announces the launch of consultations for two regulatory initiatives, marking progress in Health Canada's efforts to reduce red tape. These proposals, the Ministerial Reliance Order and regulations for Clinical Trial modernization are expected to reduce barriers to innovation, introduce new ways of conducting clinical trials and provide better access to drugs not available in Canada. 

The Ministerial Reliance Order will allow Health Canada to review certain parts of a drug submission more efficiently by leveraging decisions made by other trusted regulators without compromising quality, efficacy, and safety. These changes build on Health Canada's long history of cooperation with its international counterparts and will support greater and faster access to drugs in Canada.

Health Canada is also proposing a new regulatory framework for clinical trials for drugs that would build on the success of the existing clinical trials framework and further facilitate participant access, support innovation and enhance participant safety. This approach will provide Canadians with access to a wider range of products that could have significant health and economic benefits, including by providing quicker access to new therapies.

Quotes

"By modernizing our regulatory process and reducing red tape, these initiatives will help bring drugs and treatments to patients more quickly, supporting timely access to essential medications in Canada. This work also creates a more attractive environment for businesses, building a stronger economy while continuing to ensure high safety standards."

The Honourable Marjorie Michel
Minister of Health

Quick Facts

• The initiatives were key components of Health Canada's Red Tape Review report. They aim to modernize regulatory processes, reduce burden on regulated parties and the government while maintaining high standards to protect the health and safety of Canadians.
• Feedback from Health Canada's initial consultations on the Clinical Trials Regulations modernization is available through the What We Heard Report and helped inform this proposal.
• Both the Reliance Order and the Clinical Trials Modernization regulations have been published in the Canada Gazette, Part I, for consultation. The consultations will be open for 70 days and 90 days, respectively.
• Health Canada holds its regulatory role to the highest international standards for safety, efficacy and quality. The Department's review timelines are among the most competitive when compared to reference regulators around the world.

Associated Links

• Consultation on Ministerial Reliance Order
• Consultation on Clinical Trials Regulations and related guidance documents

SOURCE Health Canada (HC)