September 10, 2026
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: policy_bureau_enquiries@hc-sc.gc.ca
Re. Comments on Draft Guidance on the Ministerial Reliance Order for Human and Veterinary Drugs
Dear Health Canada,
On behalf of the two hundred member companies of BIOTECanada, I am writing you about Health Canada’s Draft Guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities as part of Canada Gazette, Part II. The Life Sciences and Pharmaceutical Task Force Report1 recommended Health Canada should expand and accelerate adoption of the proposed reliance framework for innovative drugs. BIOTECanada strongly supports this proposal as demonstration of Health Canada’s commitment to advancing and improving access to medicines and red tape reduction.
BIOTECanada is the national association for Canada’s biotech industry representing a mix of large multinational pharmaceutical companies, early-stage biotech companies of varying sizes, vaccine companies, drug discovery and accelerator organizations, research centers, universities, and investors. The implementation of a Reliance Order in Canada will build on investments made in the healthcare sector and further enable the collaborative regulatory authority relationship established during the pandemic and over the past years to support access to emerging technologies, an affordable healthcare system and the growth of Canada’s biotech ecosystem more broadly.
During the pandemic, the federal government recognized the strategic importance of developing a robust and diverse life sciences and biomanufacturing sector. Correspondingly, the government developed the Biomanufacturing and Life Sciences Strategy (BMLSS) led by both ISED and Health Canada. The work Health Canada undertook during this process helped establish vital new global partnerships with other respected regulators which enabled Canada to respond accordingly with rapid access to medicines and vaccines in a global health crisis. This achievement signals a new level of momentum and opportunity as Canada seeks to build capacity and maintain the health and security of Canadians.
We recognize the importance of balancing regulatory efficiency with the maintenance of robust safety and quality standards for Canadians. As a national organization representing Canada’s life sciences sector, BIOTECanada is committed to supporting Health Canada throughout the regulatory development process, including engagement in this Gazette II consultation on the development of implementation guidance.
BIOTECanada applauds Health Canada for the significant work done to achieve publication of the Ministerial Reliance Order in Canada Gazette in such a rapid timeframe. The Reliance mechanism represents an important forward thinking and modernized regulatory approach, with significant potential to reduce red tape and achieve the objectives stated in the original Regulatory Impact Analysis Statement, i.e.
- To allow Health Canada to refocus resources to address the increasing volume and complexity of drug submissions, allowing critical expertise to be directed to higher-risk and complex work;
- Encourage manufacturers to bring drugs to Canada, and file submissions earlier; and
- Reduce red tape, reduce regulatory duplication and support accelerated access to needed treatments.
Expand usage of Reliance
BIOTECanada acknowledges the unmet need for pediatric-friendly drug formulations in Canada and supports inclusion of pediatric drugs in the published IbR lists. However, Health Canada should move forward with ambition to address the recommendations of the Federal Task Force on Pharmaceuticals and Life Sciences report1, namely to:
- Expand and accelerate adoption of the proposed Reliance framework for innovative drugs
- Adopt more systematic and predictable use of Reliance on trusted foreign regulators across innovative drug approvals, establishment inspections/licensing, and lifecycle management to accelerate access and reduce duplication.
- Move quickly to expand to a broader list of drug classes that will be included in the Reliance framework where Reliance can have the greatest impact on patient access, such as oncology, HIV, and antimicrobial drugs, vaccines, drugs that treat rare diseases, and those meeting the criteria for accelerated pathways, namely Priority Review or Notice of Compliance with Conditions.
Rapid implementation of Reliance with metrics
Health Canada should commit to an implementation timeline, with a shortened submission review timeline to incentivize companies to utilize the Reliance pathway, and the first reliance review by the end of Q4 2026. We suggest that the review timeframe should be comparable to that of similar approaches internationally ie. 60-110 days under MHRA IRP.
Health Canada should establish publicly available performance indicators and regular reporting to measure uptake, timeliness, rates of rejection/acceptance of requests for deeming, operational effectiveness, measures of resource reallocation and efficiency, to ensure that the Order delivers to the objectives set out in the original RIAS.
BIOTECanada would welcome the establishment of an industry advisory group to serve as a collaborative partner to Health Canada in supporting the successful implementation of the Order and the achievement of its stated objectives, as well as those of the Pharmaceutical and Life Sciences Task Force.1
The attached document provides BIOTECanada’s input on behalf of the diverse biotechnology ecosystem.
Sincerely,
Wendy Zatylny
President and CEO
BIOTECanada
1 The Life Sciences and Pharmaceutical Task Force Report: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/pharmaceutical-life-sciences-sector-task-force/report-ministers-health-industry.html