EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods (Listing) Notice 2009 (No. 7)
Terminalia bellirica
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 7) (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 has the effect of permitting the use of ‘Terminalia bellirica’ as an active ingredient in Listed medicines for oral use, subject to specified conditions.
The Listing Notice commenced on the day after it was registered on the Federal Register of Legislative Instruments (FRLI).
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 (the 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 (the ARTG) before being supplied in, imported into, manufactured in or exported from Australia (sections 19B and 19D 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 that contain low risk ingredients are referred to as listed medicines. Most listed medicines are considered to be of relatively low risk compared to other types of medicines, such as prescription and over-the-counter medicines, as they may only contain ingredients that have been approved by the TGA as being of low risk and may only make limited 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. At present, Schedule 4 of the Regulations does not include a reference to ‘Terminalia bellirica’ but it is anticipated that it will when the Regulations are next amended.
In order to facilitate the timely approval of new listable therapeutic goods, subsection 9A(5) of the Act allows the Minister for Health to publish a listing notice that has the effect of permitting the use of particular therapeutic goods in listed medicines subject to any specified conditions.
Pursuant to subsection 9A(6) of the Act, if Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a listing notice, that listing notice ceases to have effect.
Terminalia bellirica
Terminalia bellirica is a large deciduous tree reaching up to 30 m. The fruit is a ‘drupe’, consisting of a firm outer epicarp (rind), fleshy mesocarp, and stony endocarp enclosing a single seed (similar in general structure to a peach, plum, or cherry but with harder ‘skin’). T. bellirica has a long history of purported safe use in Ayurvedic medicine, most commonly as part of a three herb combination known as Triphala, but also as a single herb. The pericarp (fruit without the seed) is used traditionally, either dried, powdered or as an aqueous extract prepared by prolonged boiling (decoction).
The ingredient T. bellirica for use as an active in Listed medicines is an aqueous extract of the dried pericarp (all fruit tissue except seeds) of T. bellirica. The recommended dose is equivalent to 5.0-7.5 g/day of the dried powdered fruit. This dose is considered to be consistent with traditional doses.
Products based on the aqueous extract of T. bellirica would be recommended for supporting the maintenance of wellness and wellbeing (based on its traditional use as a tonic) and for supporting a healthy immune system (based on its traditional reputation in improving immunity).
The safety-in-use of T. bellirica fruit pericarp and the aqueous extract is supported by evidence of traditional use. Limited human clinical trials of the fruit or aqueous extract on its own and in mixtures have not identified safety risks in relation to the aqueous extract of T. bellirica fruit pericarp.
The Complementary Medicines Evaluation Committee (CMEC) is a statutory committee established under subsection 52G(1) of the Act which gives scientific and policy advice to the Minister for Health and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of complementary listed medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products.
At its meeting in September 2009, the CMEC recommended that this substance is suitable for use as an active ingredient in listed medicines.
The delegate of the Minister made the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for ‘Terminalia bellirica’ to be used as an active ingredient in listed medicines subject to the conditions that the ingredient:
- consists of aqueous extract of the fruit pericarp (all fruit tissue without the seeds) only; &
- is included in medicines for oral administration only.
Draft Compositional Guidelines are prepared by the TGA and intended to set out the standards and requirements for the specific forms or types of substances for use in listed medicines where there is no monograph in the British Pharmacopoeia or other acceptable monograph.
The TGA has prepared draft Compositional Guidelines in relation to ‘Terminalia bellirica’, and these will be available on the TGA’s Internet site (www.tga.gov.au) for consultation for six months following the registration of the Listing Notice on the FRLI.
CONSULTATION
Although the listing of the ingredient ‘Terminalia bellirica’ is minor and machinery in nature, the CMEC was consulted during the approval process for this ingredient.
REGULATION IMPACT STATEMENT
No Regulation Impact Statement is necessary in relation to the Listing Notice as the listing of the ingredient ‘Terminalia bellirica’ is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.