Regulation of tissues
Current situation
Under the present revision of the Therapeutic Goods Act 1989 (amended June 2003), human organs, tissue and cellular products, and tissue and cell based derivatives are regulated by several different routes within the legislation.
- Organs used in direct transplant are excluded therapeutic goods (Therapeutic Goods (Excluded Goods) Order No. 1 of 2008 <http://www.tga.gov.au/legis/tgeg0801.htm>). The solutions used to flush the organs or to maintain them during transport must be listed or registered on the Australian Register of Therapeutic Goods (ARTG).
- Human tissue for implantation in the human body that is obtained, stored and supplied without any deliberate alteration to its biological and mechanical properties must comply with the Australian Code of Good Manufacturing Practice, Human Blood and Tissues <http://www.tga.gov.au/manuf/gmpbltic.htm>, but are exempt from the requirement for entry on the ARTG, under the Therapeutic Goods Regulations, Schedule 5 Item 7(q). This includes most banked tissue, such as dura mater, heart valves, skin, corneas and bone.
- Human tissue and cell extracts, whose principle therapeutic purposes are achieved through chemical, pharmacological, or metabolic actions that are generally able to be batch released, are regulated as medicines.
- Human derived tissue and cell products that
- are not regulated as medicines; and
- are produced by deliberate alteration of tissue or cells in defined manufacturing processes
- Medicines and OTGs of human origin produced or prepared for a particular person are regulated differently
- Schedule 5 Item 6 of the Regulations includes exemption of human derived medicine products from compliance with Part 3-2 of the Act (entry on the ARTG). This exemption is independent of the tissue source or associated manufacturing procedures.
- Under Schedule 5, Item 5(a), customised therapeutic devices derived from human tissue are subject to Parts 3-2 and 3-3 of the Act (entry on the ARTG and compliance with the Manufacturing Principles, cGMP).
- Schedule 5, Item 7 (q), exempts from registration a therapeutic device that is human tissue for implantation in the human body that is obtained, stored and supplied without deliberate alteration to its biological or mechanical properties by institutions whose procedures conform with the Manufacturing Principles (cGMP).
The future
The regulation of viable human and animal tissues that undergo processing and modification prior to introduction into patients is not clearly addressed in the current legislation. Technology in this area is rapidly developing, resulting in a range of products that may be considered by their very nature to be high risk for disease transmission and be of variable efficacy.
The ways in which viable human and animal tissues and cells are being isolated, selected, processed, manipulated, stored and transplanted or reimplanted necessitates that well established and consistent controls, such as those imposed through implementation of appropriate quality systems, are in place.
In July 2002, the Australian Health Ministers Conference (AHMC) recommended that the TGA introduce a national regulatory framework for human tissues and emerging biological therapies and that the therapeutic goods legislation be amended to accommodate therapeutic goods manufactured from viable human and animal tissues.
Further information on the proposed regulatory framework for tissues and biological therapies is available: Proposed regulatory framework for tissues and emerging biological therapies <http://www.tga.gov.au/bt/prtisreg.htm>.