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Therapeutic Goods Order No. 83 Standards for human musculoskeletal tissue (08/07/2011)

Therapeutic Goods Order No. 83 Standards for human musculoskeletal tissue (08/07/2011)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01489 Not in force Legislative Instrument

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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.

Overview

The Therapeutic Goods Order No. 83 (TGO 83) was enacted in 2011 under the Therapeutic Goods Act 1989 to address the need for setting standards specifically for human musculoskeletal tissue used as therapeutic goods. This legislative instrument was introduced to ensure the safety and quality of such tissues, which are critical in various medical treatments and procedures. The Act, overseen by the Therapeutic Goods Administration (TGA), provides a comprehensive regulatory framework for therapeutic goods, including biologicals such as human tissue products. TGO 83 was developed in consultation with relevant stakeholders, including the Therapeutic Goods Committee, and was subject to public consultation to gather feedback and ensure the standards were practical and effective. This order specifies technical requirements for the collection, processing, and storage of human musculoskeletal tissue, as well as criteria for microbial testing, thereby ensuring these tissues meet necessary safety and quality benchmarks before being included in the Australian Register of Therapeutic Goods. TGO 83 was enacted by the delegate of the Minister for Health and Ageing, following consultations with the Therapeutic Goods Committee, as authorised under section 10 of the Therapeutic Goods Act 1989. The policy objective of this order is to enhance the safety and quality of therapeutic goods by establishing specific standards for human musculoskeletal tissue. These standards are designed to mitigate risks associated with the use of such tissues in medical treatments, thereby protecting public health. By setting these standards, TGO 83 aims to ensure that all human musculoskeletal tissue used therapeutically in Australia meets rigorous safety and quality criteria, facilitating their inclusion in the Australian Register of Therapeutic Goods. This regulatory approach aligns with the overarching goal of the Therapeutic Goods Act to maintain a national system of controls that safeguard the quality, safety, efficacy, and timely availability of therapeutic goods.

Scope and Application

Therapeutic Goods Order No. 83 (TGO 83) is an instrument made under section 10 of the Therapeutic Goods Act 1989, establishing standards for human musculoskeletal tissue such as frozen femoral heads and freeze-dried bone that are intended for therapeutic use. This Order applies to human musculoskeletal tissue collected from both living and deceased donors, setting out minimum technical requirements that ensure the safety and quality of these tissues, including conditions for their collection, processing, and storage, as well as criteria for microbial testing. The Order is applicable nationally across Australia, as the Therapeutic Goods Act 1989 operates under the Commonwealth jurisdiction, and it commenced on 31 May 2012 to allow manufacturers adequate time to achieve compliance. Notably, TGO 83 exempts human musculoskeletal cells and tissue samples collected solely for in vitro diagnostic purposes and human musculoskeletal tissue that is processed beyond minimal manipulation, such as in-vitro cultured chondrocytes and chemically modified bone. These exemptions recognise that such products have different regulatory requirements and uses, potentially falling under other standards or codes such as the proposed Code of Good Manufacturing Practice for Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.

Key Provisions

Therapeutic Goods Order No. 83 (TGO 83), made under section 10 of the Therapeutic Goods Act 1989, establishes the standards that apply to biologicals that are human musculoskeletal tissue. This Order specifies the minimum technical requirements necessary for the safety and quality of such tissues, including conditions for collection, processing, and storage, as well as criteria for microbial testing (Section 1). The primary aim is to ensure that human musculoskeletal tissue, such as frozen femoral heads and freeze-dried bone, meets certain safety and quality standards before being used therapeutically. Notably, certain products are exempt from these requirements: human musculoskeletal cells and tissue samples collected solely for in vitro diagnosis and human musculoskeletal tissue that has undergone processing beyond minimal manipulation (Section 2). Entities and individuals involved in the manufacturing, processing, or distribution of human musculoskeletal tissue must comply with the standards set out in TGO 83. Manufacturers and suppliers must ensure that the tissue products meet the specified requirements for collection, processing, and storage. For instance, if the tissue has not been treated to remove microorganisms, it must be free of microbial growth at the time of collection. Furthermore, human tissue products that are classified as class 2, 3, or 4 biologicals must demonstrate compliance with applicable standards as part of the evaluation process for inclusion in the Australian Register of Therapeutic Goods (Section 3). This ensures that all products on the market meet necessary safety and quality benchmarks. Failure to comply with the standards set out in TGO 83 can lead to various legal consequences. Imported, supplied, or exported therapeutic goods that do not meet the applicable standards may be refused entry into, or be prohibited from being supplied in, Australia unless specific consent is granted by the Secretary under sections 14 and 14A of the Act. Additionally, any manufacturer or supplier found to be in breach of these standards may face regulatory action, including fines and potential criminal charges. The maximum penalties for contravening the Therapeutic Goods Act 1989 can be significant, depending on the severity of the breach, and may include substantial fines and imprisonment for individuals responsible for the non-compliance (Section 4).

Area of Law: Medical Law
Instrument: Regulation
Concepts: Definitions & Interpretation; Licensing & Registration; Compliance Obligations; Reporting & Disclosure Obligations

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Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.

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