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.