FACILITY REGISTRATION
for activities relating to
Human cells, tissues, cellular and tissue-based products
Blood and blood components

At the recent consultations conducted by the Therapeutic Goods Administration (TGA) on proposed regulation of human tissues and emerging biological therapies, many participants endorsed the approach of the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) to Establishment Registration allowing them to collect and maintain records of activities in this area. The participants voiced strong support for the TGA to undertake a similar program for registration of facilities and their activities in relation to human cells, tissues and biological therapies.

As foreshadowed in recent correspondence following the consultations, the TGA is now seeking the assistance of organisations and individuals in identifying activities involving human cells, tissues and biological therapies for therapeutic application.

This will help the TGA to design appropriate regulatory systems and to accommodate activities that may require oversight. Therefore, the Facility Registration Form has been designed to allow the TGA to identify organisations and individuals that are involved in activities utilising human tissues and cells. The Guidance section of this form gives examples of activities that are of interest to the TGA, and also lists a number of activities that are not intended to be covered under the Registration process. The definitions described in Guidance numbers 2 - 7 should assist your understanding of the information required when completing the Facility Registration Form.

The TGA requests your advice regarding any activities involving human cells and tissues and related products that your organisation currently manufactures.

The TGA is taking this opportunity to collect Facility Registration information and identify the spectrum of activities undertaken in relation to blood and blood components (other than plasma for fractionation) also.

For the purposes of this Form only the following definitions apply:

• Articles containing or consisting of, or derived from, human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient, other than as an ingredient of a product regulated as a medicine under the Therapeutic Goods Act 1989.
• "blood" means whole blood extracted from human donors
• "blood components" means therapeutic components that have been manufactured from blood (including red cells, white cells, stem cells, platelets and plasma), except plasma for fractionation.

Initially, the advice is being sought from stakeholders who

• received the first Discussion Paper;
• attended the consultation on regulation of human tissues and emerging biological therapies;
• participated in the Technical Master File (TMF) workshop held at the TGA in March 2003.

The attached Facility Registration Form may be down loaded from the TGA website, if additional copies are required. Moreover, if you know of other organisations or individuals who did not receive the discussion paper or attend the consultation or TMF workshops and who retrieve, process and / or supply human tissues, cells, tissue- or cellular-based therapeutic products, cell extracts, blood or blood components, please refer each to the TGA website to access copies of the Discussion Paper <http://www.tga.gov.au/docs/html/humantiss.htm>, the Summary of Outcomes of consultations on the regulation of human tissues and emerging biological therapies <http://www.tga.gov.au/bt/humantiss_outcomes.htm> and the Facility Registration Form.

You are asked to complete the attached Facility Registration Form as soon as possible and return to Dr Albert Farrugia by 11 September 2003. Early return of the information will enable us to more accurately scope the frameworks under consideration.

I look forward to receiving your details and if you have any queries regarding completion of the form please do not hesitate to contact me on 02 6232 8539.

Yours sincerely
Albert Farrugia
Head, Blood and Tissues Unit
Office of Devices, Blood & Tissues
31 July 2003