EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 83 – STANDARDS FOR HUMAN MUSCULOSKELETAL TISSUE
Section 10, Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods Order No. 83 Standards for human musculoskeletal tissue (TGO 83) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).
TGO 83 determines that the matters specified in the instrument constitute the standards applying to biologicals that are human musculoskeletal tissue. TGO 83 specifies a number of important requirements relating to human musculoskeletal tissue.
TGO 83 commences on 31 May 2012. This will allow a transition period for manufacturers to achieve compliance with the standards.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Section 10 of the Act authorises the Minister, or the Minister's delegate, to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (TGC), a committee established under the Therapeutic Goods Regulations 1990 (the Regulations) to advise the Minister on matters relating to standards.
Unless consent is granted by the Secretary under section 14 and 14A of the Act, therapeutic goods imported into Australia, supplied in Australia or exported from Australia must comply with applicable standards.
A number of new provisions have been added to the Therapeutic Goods Act 1989 (the Act) and the Regulations to establish and implement a new regulatory framework for biologicals. The new regulatory scheme for biologicals commenced on 31 May 2011.
Human tissue products, including human musculoskeletal tissue, are biologicals and are covered by the new regulatory framework for biologicals. Prior to commencement of the biologicals regulatory framework, manufacturers of human tissue, including musculoskeletal tissue, were required to hold a manufacturing licence, but such products were exempt from the requirement to be included in the Australian Register of Therapeutic Goods (the Register).
Under the new regulatory framework, human tissue products are required to be included in the Register, as biologicals. For those human tissue products (including those that are human musculoskeletal tissue) that are classified under the Regulations as being class 2, 3 or 4 biologicals (the Regulations specify and define 4 classes of biologicals), compliance with applicable standards must be demonstrated as part of the evaluation process in relation to suitability for inclusion in the Register. Applicants for inclusion of class 1 biologicals in the Register must certify that the biological conforms to every standard (if any) applicable to it.
TGO 83 is a new standard made under section 10 of the Act, and applies to human musculoskeletal tissue, such as frozen femoral heads and freeze-dried bone collected from living and deceased human donors.
TGO 83 specifies the minimum technical requirements that are considered necessary in relation to the safety and quality of human musculoskeletal tissue. The technical requirements set out in TGO 83 include requirements relating to the collection, processing and storage conditions of such tissues. In addition, TGO 83 specifies the criteria that must be met in terms of microbial testing of human musculoskeletal tissue, depending on the processing methods undertaken to reduce microbial contamination on the tissue. For example, if human musculoskeletal tissue is not subject to bioburden reduction (i.e. is not treated to remove microorganisms, such as through irradiation) after collection the tissue must be free of any microbial growth at the time of collection or must otherwise be rejected for therapeutic use.
TGO 83 provides that the following products are exempt from the requirements of the Order, those being:
- human musculoskeletal cells and tissue samples collected solely for the purpose of in vitro diagnosis; and
- human musculoskeletal tissue that is processed beyond minimal manipulation.
Diagnostic human musculoskeletal tissue samples have been exempted from the scope of TGO 83 as these samples are not for use in a recipient.
Human Musculoskeletal tissue that is processed beyond minimal manipulation has been exempted from TGO 83 because this Order has been specifically developed for tissues that have been processed within the meaning of that term as defined in regulation 2 of the Regulations. Human musculoskeletal tissues that are processed beyond minimal manipulation include chondrocytes that are cultured in-vitro for joint repair, and bone that is demineralised (i.e. chemically processed and structurally modified to remove calcium). While such products have been exempted from the requirements of TGO 83, they may be required to meet other regulatory requirements including, for example, the proposed Code of Good Manufacturing Practice for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.
CONSULTATION
A draft of TGO 83 was made available by the TGA for public consultation in December 2009. A substantially revised version, which took into account feedback received regarding the first draft, was published by the TGA in December 2010 for a second round of public consultation, at which time exclusive meetings were held with the Australasian Tissue and Biotherapeutics Forum (ATBF) to discuss details of the proposed standard.
In addition, TGO 83 has been considered and endorsed by the Therapeutic Goods Committee (the TGC) expert subcommittee on biologicals, and has been adopted by the TGC.
REGULATION IMPACT STATEMENT
The Office of Best Practice Regulation has agreed that no Regulation Impact Statement is necessary for TGO 83 (ORR ID number 12194).
It is important to note that the ‘Regulatory Impact Statement for the Regulation of Human Cellular and Tissue Therapy Products (biologicals)’ (ORR ID 5066 February 2009) included the requirement for human tissue products, including musculoskeletal tissue, to comply with standards. In addition, the proposed new standards relating to biologicals (including human musculoskeletal tissue) have been discussed with the Australian tissue banking sector and the sector has indicated that the requirements of TGO 83 are not likely to have any significant additional direct or indirect impact on the musculoskeletal tissue banking sector.