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Drugs and Health Products

Cells, Tissues and Organs

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) require that every source establishment and establishments that distribute or import cells, tissues or organs register with Health Canada. Establishments that only retrieve CTO, only import for transplant, or only transplant do not have to register.

Furthermore, based on the CTO Regulations, source establishments are to report to Health Canada suspected errors and accidents that are identified after distribution of CTO that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent, or an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent. The error and accident preliminary investigation report form is provided below.



  • Developing a Model for Scheduling Inspections of Cells, Tissues and Organs Programs - Consultation Workbook


Guides and Policies



In January 2003, Health Canada issued a Directive and Guidance Document for human cells, tissues and organs for transplantation to establishments and individuals in Canada who are involved in the handling and/or processing of these products in transplantation. The purpose of the Directive and Guidance document is to advise of the need to follow basic safety requirements for cells, tissues and organs manufactured and used in transplantation. Under the Directive, where evidence shows that cells, tissues and organs are not processed in accordance with safety standards, Health Canada will exercise its authority under Sections 8 and 19 of the Food and Drugs Act to prohibit the distribution of such products. Please note that the Directive and Guidance Document were amended in July 2005.

On June 27, 2007, the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) were published in the Canada Gazette, Part II. The purpose of this regulatory initiative is to minimize the potential health risks to Canadian recipients of human cells, tissues and organs. The CTO Regulations address safety in the processing and handling of these products, resulting in improved protection of the health and safety of Canadian transplant recipients. These Regulations, except for subsection 26(1), come into force on December 7, 2007. Subsection 26(1) comes into force on June 7, 2008.

On June 28, 2007, Health Canada also released the draft Guidance for Cells, Tissues and Organs Establishments - Safety of Human Cells, Tissues and Organs for Transplantation for a 90-day comment period. The draft guidance document is intended to accompany the CTO Regulations and provides guidance to establishments that handle, process, distribute or import human organs or minimally manipulated cells and tissues for homologous use in transplantation in another individual.