EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2010 (No.2)
Caralluma adscendens var. fimbriata
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2010 (No.2) (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 Caralluma adscendens var. fimbriata as a therapeutically active ingredient in Listed medicines, subject to specified conditions.
The Listing Notice commences on the day after it is 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 Register) 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 Register, depending on the ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk ingredients are referred to as Listed medicines in Australia. 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.
Part 1 of 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 Register for Listed medicines. At present, Part 1 of Schedule 4 of the Regulations does not cover preparations that contain Caralluma adscendens var. fimbriata as a therapeutically active ingredient.
Subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act) authorises the Minister for Health and Ageing to publish a notice in the Commonwealth of Australia Gazette, requiring specified goods to be included in the part of the Australian Register of Therapeutic Goods (the Register) for Listed goods. Such notices generally require that goods containing particular ingredients be included in the part of the Register for Listed goods. This mechanism permits the use of ingredients in Listed therapeutic goods prior to the inclusion of those ingredients in Schedule 4 of the Therapeutic Goods Regulations 1990 (the Regulations).
Under subsection 9A(6) of the Act, if the Regulations are amended to require goods that are the subject of a Listing Notice (i.e. goods noted in a Listing Notice as containing a particular ingredient or ingredients) be included in the part of the Register for Listed goods, that Listing Notice ceases to have effect.
Caralluma adscendens var. fimbriata
Caralluma adscendens var. fimbriata is an edible succulent eaten cooked or raw as a vegetable in India where it has traditionally been eaten by hunters as it suppresses the appetite for several hours.
The ingredient Caralluma adscendens var. fimbriata for use as an active in Listed medicines is a preparation of the dried aerial parts, as a hydroethanolic extract only. The hydroethanolic extract of Caralluma adscendens var. fimbriata does not have a tradition of use and as such is considered a novel substance. However, this type of extraction is permitted for all herbal ingredients, with such an extract being considered to meet the definition of a herbal substance as that term is defined in regulation 2 of the Regulations.
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. CMEC was replaced on 25 January 2010 by the Advisory Committee on Complementary Medicines as a result of changes made to the Regulations by the Therapeutic Goods Amendment Regulations 2009 (No.6)) and the repeal of Part 6-4 of the Act (which included subsection 52G(1)) by Part 2 of Schedule 7 of the Therapeutic Goods Amendment (2009 Measures No.1) Act 2009, which also commenced on 25 January 2010.
At its 74th meeting in December 2009, CMEC recommended that a hydroethanolic aqueous extract of the aerial parts Caralluma adscendens var. fimbriata is suitable for use as an active ingredient in Listed medicines, subject to the conditions that preparations containing Caralluma adscendens var. fimbriata are derived from the dried aerial parts of Caralluma adscendens var. fimbriata only and that such preparations are hydroethanolic extracts only.
The delegate of the Minister for Health and Ageing has signed the Listing Notice, a legislative instrument for the purposes of the Legislative Instrument Act 2003, to provide for ‘Caralluma adscendens var. fimbriata extract’ to be used as a therapeutically active ingredient in Listed medicines subject to the conditions that preparations of the ingredient are:
- derived from the dried aerial parts of Caralluma adscendens var. fimbriata only; and
- hydroethanolic extracts only.
Draft compositional guidelines are prepared by the TGA and are 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 Caralluma adscendens var. fimbriata hydroethanolic extract, 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 FRLI.
CONSULTATION
CMEC were 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 permitting of the use of the ingredient Caralluma adscendens var. fimbriata in Listed medicines (subject to the specified conditions) is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.