Notice - Release of the 2nd Edition of "Guidance Document for Cell, Tissue and Organ Establishments: Safety of Human Cells, Tissues and Organs for Transplantation"

June 18, 2013

Health Canada is pleased to announce the release of the 2^nd Edition Guidance Document for Cell, Tissue and Organ Establishments: Safety of Human Cells, Tissues and Organs for Transplantation(CTO Guidance document).

Background

This CTO Guidance document is intended to support adherence to the Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations) and sections of the second edition (current) of the Canadian Standards Association (CSA) standards that are referenced therein.

The second edition of CSA standards was published on December 21, 2012 and hence any cells, tissues or organs (CTO) that are processed after that date, may be considered non-compliant with the CTO Regulations if they have not been processed in accordance with those referenced sections. The following CSA standards are referenced in the CTO Regulations:

• Z900.1 Cells, Tissues, and Organs for Transplantation: General Requirements
• Z900.2.2 Tissues for Transplantation;
• Z900.2.3 Perfusable Organs for Transplantation;
• Z900.2.4 Ocular Tissues for Transplantation; and
• Z900.2.5 Lymphohematopoietic Cells for Transplantation.

A draft 2^nd Edition CTO Guidance document was shared for consultation on September 24, 2012. Since then it has been revised to reflect input received during a 75 day comment period. A final version is now ready for implementation.

Implementation

Health Canada continues to assess compliance of CTO establishments in accordance with the CTO Regulations, referenced sections of the CSA standards and the CTO Guidance document.

The following advice is provided by Health Canada:

• CTO processed prior to December 21, 2012, should have been processed according to Source Establishment Standard Operating Procedures and pursuant to the 1^st Edition (original) CTO Guidance document, which interpret CTO Regulations and previously published CSA standards
• CTO processed after December 21, 2012, must be processed according to Source Establishment Standard Operating Procedures and pursuant to revised regulatory requirements that came into force with the publication of revised CSA standards
• The 2^nd Edition CTO Guidance document can be used immediately to support adherence to new regulatory requirements that came into force with the publication of revised CSA standards
• With regards to the new requirements to test donors of bank lymphohematopoietic cells and tissues for HIV-1 and HCV using NAT, affected establishments must be in compliance no later than December 21, 2013

Copies of the CSA standards can be purchased at the  CSA Group website.

Please direct your questions on the CTO Regulations and the Guidance document, to:

Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Canada
Address locator: 0702A
Tunney's Pasture, Ottawa, Ontario, K1A 0K9
Fax: (613) 952-5364
E-mail: bgtd.opic@hc-sc.gc.ca