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Consultation: Draft Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101)

Background

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations), under the Food and Drugs Act (Act), came into force on December 7, 2007, except for subsection 26(1) which came into force on June 7, 2008. The purpose of this regulatory initiative is to minimize the potential health risks to Canadian recipients of human cells, tissues and organs.

It is the responsibility of the Inspectorate to assess compliance of programs to these regulations through compliance monitoring and inspection activities. Health Canada began inspecting Canadian registered CTO programs in August 2009, during this first phase of inspections, programs were assigned an overall compliance rating. As of April 2012, in addition to the overall compliance rating being assigned to each program, each observation noted during the inspection will also be classified as critical, major or minor.

The CTO regulations and associated Guidance Document are available on Health Canada's Compliance and Enforcement Website under Cells, Tissues and Organs:

Information on the Document for Consultation:

This Draft Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) has been developed as part of the Inspectorate program's quality system. The document provides examples of situations or observations and their assigned risk rating but is not intended as an exhaustive all-inclusive list.

How to Get Involved and Deadline

The consultation period is open for comment for 75 days, starting December 8, 2011 until February 21, 2012.

In order to read the draft document, please select the link below titled "Consultation Document":

Consultation Document

In order to submit your comments, please review the PDF document and email your comments to the following address: btox_stox@hc-sc.gc.ca.

*Please use the Adobe (PDF) version of the document, to ensure accuracy in line numbers.

Note that any information collected will only be used for input to the consultation.

Blood, Tissues, Organs and Xenografts Unit (BTOX)
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Ottawa, Ontario  K1A 0K9
Phone: 613-954-5011
Fax: 613-946-5636
Email: btox_stox@hc-sc.gc.ca.

Comments received from stakeholders and interested parties will be reviewed after the 75 days comment period.

Interested parties are encouraged to provide comments by February 21, 2012 on the above document.

Reporting to Canadians

Once finalized, this Guidance Document will be posted on the Health Canada Website.

If you have any questions, please contact us at the Blood, Tissues, Organs and Xenografts Unit.

Yours truly

Diana Dowthwaite
Director General