Notice to Stakeholders - Regulatory Framework for the Safety of Cells, Tissues and Organs for Transplantation

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Contact Policy and Promotion Division

Biologics and Genetic
Therapies Directorate
2^nd Floor, Building # 7
Address Locator # 0702E
Tunney's Pasture
OTTAWA, Ontario
K1A 0L2

August 18, 2004

04-110138-325

Notice to Stakeholders - Regulatory Framework for the Safety of Cells, Tissues and Organs for Transplantation

This is a follow-up notice to the Notice to Stakeholders sent in August, 2003.

Background

Health Canada would like to update all establishments and individuals in Canada which handle and/or process human cells, tissues, and organs, as to the status of the proposed new regulatory framework. These new regulations will address safety in the manufacture and use of these products for transplantation. The proposed initiative is intended to revise the regulatory requirements, in order to reflect current practices and technology.

Health Canada is the federal authority which regulates the safety, efficacy and quality of therapeutic products used in Canada, pursuant to the Food and Drugs Act (F&DA). Health Canada collaborates with provincial and territorial governments, other regulatory agencies, trade associations, health professionals and their associations, as well as consumers and their associations to fulfill its mandate.

Although the authority for regulating cells, tissues and organs is found in the F&DA, to date, there has been no consistent regulatory approach to ensuring the safety of cells, tissues, and organs for transplantation. Some tissues are regulated as drugs; some as medical devices. With a few exceptions, tissues and organs are not separately and specifically regulated under the Food and Drug Regulations. Moreover, Canadian facilities, engaged in transplantation, currently employ multiple sets of voluntary safety standards that vary in their comprehensiveness.

The regulations will be based on the National Safety Standards, which were developed by the Canadian Standards Association (CSA), in extensive collaboration with experts in the field, government representatives and other stakeholders. The standards were released by the CSA in June 2003, and are available for purchase through the CSA.

By referencing the standards, the proposed regulations will set out basic safety requirements with respect to donor suitability assessment, and the collection/retrieval, processing, preservation, packaging, labelling, storage, quarantining, record keeping, distribution, importation, adverse event reporting, investigation, and recall of cells, tissues and organs for transplantation.

Update

The regulations will be implemented in two phases. The first phase will focus on the safety and quality of cells, tissues and organs for transplantation. It is proposed that this phase will include a registration scheme for those establishments that process or distribute cells, tissues and organs. Once the first phase of the regulations is in place, those establishments will be notified and required to apply for registration with Health Canada. The application for registration will require an declaration, on the part of the establishments, that they are complying with the regulations. After approval of the application, a registration number will be assigned to the applicant establishment. During implementation, there will be a transition lead-in time. Establishments which are currently engaged in these activities will have an opportunity to apply for and receive their registration number, without interrupting operations.

There is a limited supply of tissues for transplantation, resulting in long waiting lists for certain procedures. In recognition of this, Phase I will include provisions for the use of banked cells and tissues which were processed prior to the enactment of the regulations and which do not meet all the requirements of the regulations. These transitional measures will, with their strict safety criteria, allow establishments to determine the suitability of banked cells and tissues for transplantation.

The second phase will build on the safety-based regulations created in Phase I. Phase II will amend the regulations to incorporate a surveillance and adverse event reporting strategy and a comprehensive compliance and enforcement strategy. This may include, for example, licensing and/or accreditation of facilities. Future communication with stakeholders will be forthcoming, in order for Health Canada to commence the public consultations on these two strategies.

To support the two-phased regulatory framework development, an Expert Advisory Committee on Cells, Tissues and Organs Regulation is being established. The Committee's mandate will be to provide Health Canada with timely advice on issues under federal responsibility for ensuring the safety, quality and efficacy of human cells, tissues and organs as therapeutic products intended for transplantation.

In closing, I would ask that you please forward this update to any person within your facility who is involved in the donation or transplantation of cells, tissues or organs for transplantation. This includes: in-house surgical bone banks; organ donation organizations; tissue retrieval organizations; tissue banks; cell or tissue processing facilities; cell culture laboratories; histocompatibility laboratories; transplant programs and facilities; bone marrow transplantation programs; cord blood banks; stem cell transplantation programs; distributors; and any other cell, tissue or organ dispensing services.

Health Canada will continue to report on the progress of this important regulatory initiative. You may also find more information on our website. Any comments or queries you may have regarding this update or the status of the regulations may be directed to (613) 954-1798 or to BGTD_PPD_DPP@hc-sc.gc.ca.

Yours sincerely,

Pierre Charest
A/Director General