EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2008 (No. 3)
Arabinogalactan - Larix
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2008 (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 Arabinogalactan - Larix as an active ingredient in Listed complementary medicines for oral use with certain conditions.
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 (section 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 such as vitamins, minerals, nutritional supplements and herbal, homoeopathic and aromatherapy products are regarded 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 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. Part 5 of Schedule 4 is for substances other than vitamins, minerals and plant material that are for use in Listed medicines. Division 2 of Part 5 is for substances for which a dosage limit is specified in the Regulations.
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 Schedule 4 of the Regulations is amended to include reference to a substance that has been the subject of a Listing Notice, the Listing Notice ceases to have effect.
The ingredient Arabinogalactan - Larix, also known as larch arabinogalactan, refers to arabinogalactan derived from the mixture of arabinogalactans obtained from Larix occidentalis and Larix larcinia (Western and Eastern larch trees, respectively). Arabinogalactan - Larix with a high polysaccharide content of greater than or equal to 85% is considered safe for use as an active ingredient in Listed medicines for oral use.
The draft Compositional Guideline for Arabinogalactan - Larix defines the proposed ingredient as material derived from Larix occidentalis (Western larch) and/or Larix larcinia (Eastern larch) wood by water extraction. It consists of galactose and arabinose subunits occurring in an approximate ratio of 6:1. Its molecular weight ranges from 15,000 to 60,000 daltons. The safety-in-use of lower grades of Arabinogalactan - Larix has not been demonstrated in clinical trials. However, other types of arabinogalactans are found in many common food plants and herbs.
The 64th Complementary Medicines Evaluation Committee (CMEC) meeting was asked to advise whether Arabinogalactan - Larix is suitable as an ingredient in Listed medicines. 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 Ageing and the Secretary to the Department of Health and Ageing regarding controls on the supply and use of complementary medicines, with particular reference to the safety and quality of products and, where appropriate, efficacy relating to the claims made for products. CMEC has recommended that this ingredient is suitable for use as an active ingredient in Listed medicines for oral use subject to the following conditions:
- the ingredient Arabinogalactan – Larix is derived from Larix occidentalis or Larix larcinia;
- the concentration of polysaccharides in the ingredient Arabinogalactan – Larix is greater than or equal to 85%; and
- the maximum daily dose of the ingredient Arabinogalactan – Larix is not to exceed 15 grams.
CONSULTATION
Although the listing of the ingredient Arabinogalactan – Larix is minor and machinery in nature, the Complementary Medicines Evaluation Committee 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 Arabinogalactan – Larix is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.