Forward Regulatory Plan 2023-2025: Regulations Amending the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Title of Regulatory Initiative

Regulations Amending the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Enabling Act

Food and Drugs Act


Health Canada is proposing amendments to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations to reflect the current standards of practice and organizational structure of the donation and transplantation systems in Canada.

The proposed amendments would:

Regulatory cooperation efforts (domestic and international)

This initiative is not part of a formal regulatory cooperation work plan.

The amendments would align the classification of human heart valves used in transplantation with that of the United States Food and Drug Administration.

These amendments would also better reflect the organizational structure of provincially funded donation and transplantation systems.

Potential impacts on people in Canada, including businesses

The proposed amendments would apply to stakeholders involved in the transplantation of human cells, tissues and organs in Canada.

Health Canada would expect this proposal to increase the supply of human heart valves available in Canada due to reduced barriers to market entry in Canada for United States-based tissue banks that process human heart valves. The proposal is expected to eliminate redundancy in the system, for example, costs associated with duplicate donor suitability assessments and donor travel related expenses.


Targeted 30-day consultations with donation and transplantation programs were launched on January 5, 2022.

Health Canada has engaged and consulted with various stakeholders over the years, including tissue banks and living organ donor programs.

Further stakeholder engagement will likely be needed prior to bringing forward a regulatory proposal.

Further information

Related information can be found on:

Cells, Tissues and Organs

Additional information can be requested from the departmental contact.

Departmental contact information

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada

Telephone: 613-321-4235

Date the regulatory initiative was first included in the Forward Regulatory Plan

February 2021

Consult Health Canada's acts and regulations web page for:

Consult the following for links to the Cabinet Directive on Regulation and supporting policies and guidance, and for information on government-wide regulatory initiatives implemented by departments and agencies across the Government of Canada:

To learn about upcoming or ongoing consultations on proposed federal regulations, visit:

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