The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO regulations) contain safety requirements for:
Processing includes the following activities:
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.
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:
It is your responsibility to make sure you are accessing the most recent version of:
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.
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:
Note: The national standard speaks to various aspects of the donation and transplantation process. However, our scope for cells, tissues and organs is limited to activities related to product safety and quality assurance. Every section of the national standard that is referenced in the CTO regulations concerns the safety or quality of cells, tissues and organs. The regulations do not reference sections of the national standard that concern the practice of medicine, which does not fall under federal jurisdiction.
The CTO regulations set out safety requirements for:
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.
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:
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:
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
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.
