Guidance on the Safety of Human Cells, Tissues and Organs for Transplantation Regulations: Overview

Date revised: 2024-04-11

On this page

• Purpose
• Scope and application
• Policy objectives
• Background
• Acronyms
• Note about guidance documents in general

Purpose

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations) contain safety requirements for:

• processing
• storage
• keeping records
• distribution
• importation
• investigating and reporting errors, accidents and adverse reactions

Processing includes the following activities:

• donor screening
• donor testing
• donor suitability assessment
• retrieval, except for organs and islet cells
• testing and performing measurements on cells, tissues or organs after they are retrieved
• preparing cells and tissues for use in transplantation
  • does not apply to organs
• preserving, quarantining and banking
• packaging and labelling

The CTO regulations are intended to improve protections for the health and safety of people in Canada who receive transplants.

Health Canada's Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, administers the CTO regulations. If you have questions about the regulations or this guidance document, please email us: brdd-cppic_brdd-cppci@hc-sc.gc.ca.

Scope and application

The CTO regulations apply only to human cells, tissues and organs that are to be used in transplantation. Cells, tissues and organs donated for different purposes, such as for education or non-clinical research, are not within the scope of these regulations.

This guidance document outlines the scope of the CTO regulations as well as the activities they govern. It is an important point of reference to help readers determine whether a product and the activities related to it are governed by the CTO regulations. It also gives details on what the current safety requirements for cells, tissues and organs used in transplantation must be fulfilled.

This guidance document supersedes previous documents.

The CTO regulations apply to individuals and establishments that handle, process, distribute or import human organs, or minimally manipulated cells and tissues for homologous (same basic function after transplantation) use, for transplantation in a person. To fully comprehend these regulations, you must also consult the:

• Food and Drugs Act
• national standard on cells, tissues and organs for transplantation, published by the Canadian Standards Association

It is your responsibility to make sure you are accessing the most recent version of:

• the CTO regulations
• the national standard
  • which is incorporated by reference into the regulations
• this guidance document

Policy objectives

The purpose of this regulatory framework is to minimize the potential health risks to people in Canada who receive human cells, tissues and organs. This guidance document interprets the CTO regulations.

Background

These regulations establish safety requirements for processing and handling human cells, tissues and organs for transplantation. These requirements will improve protections for the health and safety of people in Canada who receive transplants.

The CTO regulations are based on the national standard as well as information obtained during extensive consultations with the provinces, territories and transplantation experts. We used a risk management approach to develop the regulations. Through international regulatory cooperation, the national standard is available for other nations to model.

The following are mandatory as they are referenced directly in the CTO regulations:

• sections of the general standard CAN/CSA Z900.1, "Cells, Tissues, and Organs for Transplantation: General Requirements"
• sections of the subset standards for specific organ and tissue types
  • lymphohematopoietic cells, perfusable organs, tissues and ocular tissues

The CTO regulations set out safety requirements for:

• processing, which includes:
  • screening and testing donors
  • collecting and retrieving cells, tissues and organs
  • preserving, packaging, labelling and quarantining
• storing
• keeping records
• distributing
• importing
• investigating and reporting on errors, accidents and adverse reactions

The regulations are designed to maximize the safety of cells, tissues and organs. They clearly outline the safety requirements adopted from the national standard, thus making them mandatory. Referencing the national standard provides a consistent and safety-focused regulatory framework that will minimize the risks to people in Canada who receive cells, tissues and organs.

CSA Group national standard

You can order the Z900 package of the national standard by calling 1-800-463-6727 or visiting the CSA Group website. The CTO regulations are standard-based. This means that CTO establishments:

• must comply with sections of the national standard referenced in the regulations
• should have the most updated version of the standard, to access the latest regulatory requirements

The regulations incorporate by reference the applicable standards as amended from time to time. Amendments to the national standard will be sent to establishments that have registered their package with the CSA Group.

Find out more on how to register your national standards and receive updates by consulting the CSA Group standards update service page.

The field of CTO donation and transplantation is changing as the science evolves. Thus, we are basing our regulatory framework on the standards. A committee of transplantation experts and interested stakeholders developed the national standard together. This consensus-driven process may enhance future compliance.

All stakeholders play a key role in keeping the standards up to date. Each subset of the CSA Group national standard contains a Proposal for Change Form. Stakeholders may use this form to submit proposals for change directly to the CSA Group. Along with the appropriate contact information, the CSA Group asks that stakeholders supply the following information, to help them evaluate proposed changes:

• standard/publication number
• relevant clause, table and/or figure number(s)
• wording of the proposed change
• rationale for the change

Acronyms

CMV

cytomegalovirus

CSA

CSA Group

CTOs

cells, tissues and organs

EBV

Epstein-Barr virus

HBV

Hepatitis B virus

HCV

Hepatitis C virus

HIV

Human Immunodeficiency virus

HLA

human leukocyte antigen

HTLV

Human T-Lymphotropic virus

MDALL

Medical Devices Active Licence Listing

NAT

nucleic acid testing

ROEB

Regulatory Operations and Enforcement Branch (formerly Health Products and Food Branch Inspectorate)

WNV

West Nile virus

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.