Service Standard for Registration of an Establishment under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Disclaimer: Information on this webpage is provided for illustrative purposes only. The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations or Regulations) should be relied upon for specific requirements, including if there are discrepancies between this page and the CTO Regulations.

Service Description:

Health Canada posts service standards and performance information for services with over 100 regulatory authorizations, such as permits, licences, or registrations issued each year (high-volume regulatory transactions).

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations or Regulations) contain safety requirements with respect to processing, storage, record keeping, distribution, importation, error, accident, and adverse reaction investigation and reporting. Processing includes donor screening; donor testing; donor suitability assessment; retrieval (except in the case of organs and islet cells); testing and measurements performed on the cells, tissues or organs (CTO) after they are retrieved; preparation for use in transplantation (except for organs); preservation; quarantine; banking; packaging; and, labelling. These Regulations are intended to result in improved protection of the health and safety of Canadian transplant recipients.

The Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation, is intended to provide an interpretation of the CTO Regulations. Both the scope of the CTO Regulations, as well as the activities they govern, are outlined. It is intended to be an important point of reference: it will help readers determine whether a product and the related activities are governed by the CTO Regulations, and give more detail as to which requirements must be fulfilled. The requirements that are discussed in this document are the current safety requirements for CTO used in transplantation.

Service Standard:

The Regulatory Operations and Enforcement Branch (ROEB) commits to service delivery standard of 90 calendar days, for the issuance of a decision on an application for registration of a cell, tissue and organ (CTO) establishment, including the review of initial and renewal registration applications, from the date of receipt of a complete application.

Performance Target:

The target for achieving this standard is set at 90% of submissions being completed within applicable review timelines.

Performance result in fiscal year 2018 to 2019:

Annual service performance is measured over the course of the fiscal year (April 1 – March 31).

In 2018-2019, ROEB completed 97% of submissions within applicable review timelines.

Departmental Contacts:

All completed applications, as well as all inquiries pertaining to the status of an establishment's registration should be sent to the Biological Product Compliance Program at the following email address: hc.roeb.cto-dgoral.sc@canada.ca
Biological Product Compliance Program (BPCP)
3rd Floor, Jeanne Mance Building
200 Eglantine Driveway, Tunney’s Pasture

Address Locator: 1903D
Ottawa, Ontario K1A 0K9
Telephone: 613-946-8844
Fax: 613-960-2156
Teletypewriter: 1-800-267-1245 (Health Canada)
E-mail: hc.roeb.cto-dgoral.sc@canada.ca

All other inquiries can be directed to the Office of Policy and International Collaboration in the Biologics and Genetic Therapies Directorate, at hc.bgtd.opic-bpci.dpbtg.sc@canada.ca.

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