Therapeutic Goods Order No. 86 Standards for human skin (08/07/2011)

Administered by Department of Health, Disability and Ageing

Legislation au F2011L01492 Not in force Legislative Instrument

Select Document

EXPLANATORY STATEMENT

Subject: THERAPEUTIC GOODS ORDER NO. 86 – STANDARDS FOR HUMAN SKIN

Section 10, Therapeutic Goods Act 1989

OUTLINE

Therapeutic Goods Order No. 86 Standards for human skin and (TGO 86) 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 86 determines that the matters specified in the instrument constitute the standards applying to biologicals that are human skin. TGO 86 specifies a number of important requirements relating to human.

TGO 86 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 skin, 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 skin, 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 skin) 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 86 is a new standard made under section 10 of the Act, and applies to human skin collected from living and deceased human donors.

TGO 86 specifies the minimum technical requirements that are considered necessary in relation to the safety and quality of human skin. The technical requirements set out in TGO 86 include requirements relating to the collection, microbial testing, processing, packaging and storage conditions of such tissues. TGO 86 specifies that if microbial growth of clinically significant organisms is detected on the tissue, the skin must not be used for transplantation.

TGO 86 provides that the following products are exempt from the requirements of the Order, those being:

human skin collected solely for the purpose of in vitro diagnosis; and
human skin that is processed beyond minimal manipulation.

Diagnostic human skin samples have been exempted from the scope of TGO 86 as these samples are not for use in a recipient.

Human skin that is processed beyond minimal manipulation has been exempted from TGO 86 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 skin tissues that are processed beyond minimal manipulation include keratinocytes or dermal substitutes, which are made from skin that is dissociated into individual cells and subsequently grown in culture. While such products have been exempted from the requirements of TGO 86, 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 86 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 86 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 86 (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 human skin, to comply with standards. In addition, the proposed new standards relating to biologicals (including human skin) have been discussed with the Australian tissue banking sector and the sector has indicated that the requirements of TGO 86 are not likely to have any significant additional direct or indirect impact on the skin banking sector.

Overview

The Therapeutic Goods Order No. 86 (TGO 86) was enacted in 2011 as a standard for human skin under the Therapeutic Goods Act 1989. This legislation was introduced to address the need for a national system of controls relating to the quality, safety, efficacy, and timely availability of therapeutic goods, including human tissue products such as skin. The Therapeutic Goods Administration (TGA) is responsible for administering this Act, and TGO 86 was made by the delegate of the Minister for Health and Ageing, following consultation with the Therapeutic Goods Committee (TGC). The policy objective of TGO 86 is to establish minimum technical requirements for the collection, microbial testing, processing, packaging, and storage conditions of human skin to ensure safety and quality standards are met. It specifies that if microbial growth of clinically significant organisms is detected, the skin must not be used for transplantation. Certain products, such as human skin collected solely for the purpose of in vitro diagnosis and those processed beyond minimal manipulation, are exempt from these requirements. The Order allows for a transition period for compliance and has undergone public consultation and endorsement by relevant expert committees.

Scope and Application

Therapeutic Goods Order No. 86, established under Section 10 of the Therapeutic Goods Act 1989, pertains to the standards for human skin, specifically biologicals. This Order, which commenced on 31 May 2012, applies to human skin collected from both living and deceased donors. The primary objective of TGO 86 is to ensure the safety and quality of human skin intended for therapeutic use by outlining essential technical requirements. These requirements encompass the collection, microbial testing, processing, packaging, and storage conditions of human skin, with a critical stipulation that skin with detected microbial growth of clinically significant organisms must not be used for transplantation. While the Order applies broadly to human skin biologicals, it excludes certain products from its scope. Specifically, human skin collected for the purpose of in vitro diagnosis and human skin that has undergone processing beyond minimal manipulation, such as keratinocytes or dermal substitutes, are exempt from the requirements of TGO 86. This exclusion is due to the distinct nature and regulatory considerations of these processed products, which may still need to comply with other regulatory requirements. The Order's jurisdiction is national, aligning with the broader framework of the Therapeutic Goods Act 1989, administered by the Therapeutic Goods Administration.

Key Provisions

The Therapeutic Goods Order No. 86 (TGO 86) establishes the standards for human skin as biologicals under section 10 of the Therapeutic Goods Act 1989 (the Act). This Order specifies the technical requirements necessary to ensure the safety and quality of human skin used for therapeutic purposes, including the collection, microbial testing, processing, packaging, and storage conditions (section 2). Notably, TGO 86 mandates that human skin exhibiting microbial growth of clinically significant organisms must not be used for transplantation (section 3). It also outlines exceptions, such as human skin collected for in vitro diagnosis and skin that has undergone processing beyond minimal manipulation, which are exempt from these standards (section 4). Compliance with TGO 86 imposes several obligations on parties involved in the handling and processing of human skin for therapeutic use. Manufacturers and suppliers must adhere to the specified standards to ensure that the human skin they produce or distribute is safe and of high quality. This includes implementing rigorous microbial testing protocols and maintaining appropriate storage conditions to prevent contamination and degradation of the tissue. Additionally, any entity seeking to include class 2, 3, or 4 biologicals in the Australian Register of Therapeutic Goods must demonstrate compliance with the applicable standards as part of their evaluation (section 5). For class 1 biologicals, applicants must certify that the biological conforms to every applicable standard (section 6). Violations of TGO 86 may result in significant legal consequences. The Therapeutic Goods Act 1989 includes provisions for both civil and criminal penalties for non-compliance. For example, supplying therapeutic goods that do not meet the required standards can lead to substantial fines, with the maximum penalty often reflecting the severity of the breach. Furthermore, repeated or egregious violations may result in more severe criminal penalties, including imprisonment. It is essential for parties to ensure that they fully understand and adhere to the standards set forth in TGO 86 to avoid these potential consequences.

Area of Law: Medical Law; Regulatory Standards
Instrument: Order
Concepts: Definitions & Interpretation; Compliance Obligations; Enforcement Powers

Interactions

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.

Legislation content