EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2009 (No. 1)
Alpha-casozepine enriched hydrolysed milk protein
Section 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2009 (No. 1) (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 alpha-casozepine enriched hydrolysed milk protein as an active ingredient in listed medicines for oral use. Products containing alpha-casozepine enriched hydrolysed milk protein are subject to the inclusion of advisory statements on the label.
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. Part 5 of Schedule 4 specifies substances other than vitamins, minerals and plant material that are for use in listed medicines. Division 1 of Part 5 specifies substances not mentioned in Divisions 2 or 3 that may be ingredients of preparations. At present, Schedule 4 of the Regulations does not include a reference to alpha-casozepine enriched hydrolysed milk protein but it is anticipated that Division 1 of Part 5 of Schedule 4 of the Regulations will include a reference alpha-casozepine enriched hydrolysed milk protein 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 and Ageing 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, when 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.
Alpha-casozepine enriched hydrolysed milk protein
Alpha-casozepine enriched hydrolysed milk protein is derived from bovine skim milk and may have components in common with those produced from milk and milk products during digestion.
Although, the ingredient alpha-casozepine enriched hydrolysed milk protein does not have a history of traditional use, it has been available to consumers in a number of countries, including Australia and Canada, for up to 7 years at doses of 150-600 mg/day. Other forms of milk protein hydrolysate have been used worldwide for many years.
The ingredient milk protein hydrolysed is approved for use as an excipient in medicines in Australia. Milk protein hydrolysed is defined as ‘the hydrolysate of milk protein derived by acid, enzyme or other method of hydrolysis’. The definition of alpha casozepine enriched hydrolysed milk protein as ‘a spray dried powder derived from the trypsin hydrolysis of the casein rich fraction of bovine skim milk’ is consistent with this.
No adverse reactions were located in the Australian or Canadian databases for alpha-casozepine enriched hydrolysed milk protein or milk protein hydrolysate.
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 Ageing 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.
In October 2008, the CMEC recommended approval of alpha-casozepine enriched hydrolysed milk protein for use in listed medicines for oral use subject to the inclusion of appropriate label statements advising:
- the ingredient is derived from cow’s milk; and
- products containing the ingredient are not suitable for use in children under the age of 12 months, except on professional advice.
To ensure consistency with existing label advisory statements, the ingredient has been approved for use in listed medicines for oral use subject to the inclusion of the following label statements:
- “Derived from cow’s milk”; and
- “Not suitable for use in children under the age of 12 months, except on professional advice”.
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 alpha-casozepine enriched hydrolysed milk protein, and these will be available on the TGA’s web 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 alpha-casozepine enriched hydrolysed milk protein 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 alpha-casozepine enriched hydrolysed milk protein is minor and machinery in nature with no or low compliance costs and impact on business, individuals or the economy.