EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2006 (No. 3)
Trametes versicolor proteoglycan concentrate
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2006 (No. 3) (the Listing Notice) is a Notice made by the delegate of the Minister for Health and Ageing under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice permits the use of “Trametes versicolor proteoglycan concentrate” as an active ingredient in low risk (Listed) complementary medicines for oral use.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Unless specifically exempted or authorised under the Act, therapeutic goods are required to be included in the Australian Register of Therapeutic Goods (ARTG) before being supplied in, imported into, manufactured in, or exported from Australia (subsection 20(1) of the Act). Medicines are Registered or Listed in the ARTG, depending on the ingredients they contain and the therapeutic claims that are being made.
In Australia, products such as vitamins, minerals, nutritional supplements and herbal, aromatherapy and homoeopathic products are regulated as ‘complementary’ medicines. Most, but not all, complementary medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, and are Listed in the ARTG. Listed medicines may only contain ingredients that have been approved by the TGA as being of low risk and may only make certain therapeutic claims.
Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations) sets out those therapeutic goods that are required to be included in the part of the ARTG for Listed medicines.
In order to facilitate the timely approval of new Listable substances, subsection 9A(5) of the Act allows the Minister for Health and Ageing to publish a Listing Notice that has the effect of permitting the use of particular substances in Listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, when the Regulations are amended to require any of those goods that have been the subject of a Listing Notice to be included in the part of the ARTG for Listed goods, the Listing Notice ceases to have effect.
“Trametes versicolor proteoglycan concentrate” is a concentrated dry hot-water extract of the filaments that make up the body of the edible fungus, Trametes versicolor. Trametes versicolor has a long traditional use in both Chinese and Japanese medicine for a range of ailments.
Trametes versicolor extracts appear to have low toxicity in animals, with few reported adverse effects in humans.
“Trametes versicolor proteoglycan concentrate” is chemically equivalent to “Trametes versicolor hyphae aqueous extract – powder”, which is approved for use in Listed medicines.
The long history of use of T. versicolor as a traditional medicine supported the safety and suitability of “Trametes versicolor proteoglycan concentrate” for use as an active ingredient in Listed medicines for oral use.
CONSULTATION
This substance has been reviewed by the Complementary Medicines Evaluation Committee (CMEC), which is comprised of some of Australia’s leading experts on complementary medicines. CMEC provides scientific and policy advice to the TGA relating to controls on the supply and use of complementary medicines, with particular reference to safety, quality and where appropriate, efficacy.
CMEC recommended that “Trametes versicolor proteoglycan concentrate” was suitable for use as an active ingredient in Listed medicines for oral use.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the regulation change is minor and machinery in nature.
Overview
The Therapeutic Goods (Listing) Notice 2006 (No. 3) was enacted to address the need for timely approval of new substances for use in Listed medicines, as permitted under section 9A(5) of the Therapeutic Goods Act 1989. This legislative instrument was introduced by the delegate of the Minister for Health and Ageing and allows the use of "Trametes versicolor proteoglycan concentrate" as an active ingredient in low-risk complementary medicines for oral use. The objective of the Notice is to facilitate the inclusion of new Listable substances in the Australian Register of Therapeutic Goods, ensuring the quality, safety, efficacy, and timely availability of therapeutic goods in Australia. The Notice was reviewed by the Complementary Medicines Evaluation Committee, which concluded that "Trametes versicolor proteoglycan concentrate" is suitable for use in Listed medicines, given its long history of safe use in traditional Chinese and Japanese medicine.
Scope and Application
The Therapeutic Goods (Listing) Notice 2006 (No. 3) applies to the use of "Trametes versicolor proteoglycan concentrate" as an active ingredient in low-risk, listed complementary medicines intended for oral use. This Notice was made under the Therapeutic Goods Act 1989 and commenced on the day following its registration on the Federal Register of Legislative Instruments. It pertains to entities and individuals involved in the manufacture, supply, or import of listed medicines containing this specific ingredient. The Act is administered nationally by the Therapeutic Goods Administration (TGA) and applies to therapeutic goods used or exported from Australia. The Notice itself does not include specific exclusions, but any use of the substance outside the parameters set by the Notice would not be permitted. The scope of the Notice may be extended or restricted through amendments to the Therapeutic Goods Regulations 1990, which determine the inclusion of goods in the Australian Register of Therapeutic Goods. The Notice ceases to have effect when the Regulations require the inclusion of the listed goods containing "Trametes versicolor proteoglycan concentrate" in the ARTG for Listed medicines.
Key Provisions
The Therapeutic Goods (Listing) Notice 2006 (No. 3) (Listing Notice), made under section 9A(5) of the Therapeutic Goods Act 1989 (Act), allows the use of "Trametes versicolor proteoglycan concentrate" as an active ingredient in low-risk, oral complementary medicines (section 1). This notice came into effect the day after its registration on the Federal Register of Legislative Instruments. The notice provides for the use of this particular substance, derived from the edible fungus Trametes versicolor, in Listed medicines. This ingredient has been reviewed and deemed suitable for use in these medicines by the Complementary Medicines Evaluation Committee (CMEC), a body consisting of Australia's leading experts on complementary medicines.
The Act requires therapeutic goods to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied, imported, manufactured, or exported in Australia (section 20(1)). Complementary medicines, including those containing "Trametes versicolor proteoglycan concentrate," fall under the category of Listed medicines in the ARTG. These medicines are considered low-risk and can only contain ingredients approved by the Therapeutic Goods Administration (TGA) as low-risk. They are also restricted in the types of therapeutic claims they can make. Schedule 4 of the Therapeutic Goods Regulations 1990 outlines the therapeutic goods that must be included in the ARTG for Listed medicines.
Entities and individuals governed by the Act are required to comply with its provisions, including the requirements for listing medicines in the ARTG and ensuring that any active ingredients used, such as "Trametes versicolor proteoglycan concentrate," are approved for use in Listed medicines. Manufacturers, importers, and suppliers of complementary medicines must ensure that the products they supply comply with the Act and the relevant regulations, including the provisions of the Listing Notice.
The Act provides for various civil and criminal penalties for breaches. For example, under section 32 of the Act, a person who supplies therapeutic goods that do not comply with the Act can be liable for a civil penalty of up to $22,200 for a corporation and $4,440 for an individual, or imprisonment for up to 12 months, or both. Criminal penalties can also apply for more serious breaches, with maximum penalties varying depending on the nature and severity of the offence. The specifics of these penalties are detailed in other sections of the Act and relevant regulations.