December 19, 2025 | Ottawa, Ontario
Health Canada has launched public consultations on two major regulatory initiatives aimed at reducing red tape and improving access to drugs in Canada. The announcement was made by Marjorie Michel and represents a significant step toward modernizing Canada’s drug approval and clinical trial systems.
The proposed initiatives are designed to speed up access to safe and effective medications while maintaining Canada’s high standards for quality, efficacy, and patient safety.
Proposed Regulatory Initiatives
1. Ministerial Reliance Order
The Ministerial Reliance Order would allow Health Canada to review parts of a drug submission more efficiently by relying on regulatory decisions made by trusted international counterparts. Instead of duplicating assessments that have already been completed by other regulators, Health Canada would be able to use those reviews to support its own decision making.
This approach builds on Canada’s long history of international regulatory cooperation and is expected to shorten review timelines. As a result, Canadians could gain faster access to drugs that are already approved in comparable jurisdictions.
2. Modernized Clinical Trials Framework
Health Canada is also proposing a new regulatory framework for clinical trials involving drugs. This framework would build on the existing clinical trials system and further modernize how trials are conducted in Canada.
The proposed changes aim to facilitate participant access to trials, support innovation in trial design, and strengthen participant safety. By improving the clinical trial environment, Canadians may gain earlier access to new therapies while Canada becomes a more attractive destination for clinical research with potential health and economic benefits.
Why This Matters
These initiatives are key components of Health Canada’s Red Tape Review, which focuses on modernizing regulatory processes and reducing unnecessary administrative burden while maintaining strong protections for public health and safety.
Health Canada notes that its drug review timelines are already among the most competitive internationally. The proposed reforms are intended to improve efficiency even further without lowering regulatory standards.
Minister Michel emphasized that modernizing the regulatory process can help bring treatments to patients more quickly while supporting innovation and strengthening the Canadian economy.
Public Consultation Process
Both proposals have been published in the Canada Gazette Part I and are open for public consultation.
The consultation period for the Ministerial Reliance Order will remain open for 70 days. The consultation period for the Clinical Trials Modernization Regulations will remain open for 90 days.
Health Canada has also released a What We Heard report summarizing feedback from earlier consultations on clinical trials modernization. This feedback helped inform the current proposals.
Looking Ahead
If implemented, these reforms could significantly reshape how drugs and clinical trials are regulated in Canada. The changes have the potential to improve patient access to therapies, support innovation in the life sciences sector, and strengthen Canada’s role in global health research.
Researchers, industry stakeholders, and members of the public are encouraged to review the proposals and provide feedback during the consultation period.
Source: Health Canada News Release
Website: healthcanadatoday.com