EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2012 (NO. 4)
Calcified Lithothamnion tophiforme
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2012 (No. 4) (the Listing Notice) is a notice made by the delegate of the Minister for Health under subsection 9A(5) of the Therapeutic Goods Act 1989 (the Act).
The Listing Notice has the effect of requiring that therapeutic goods that contain ‘calcified Lithothamnion tophiforme’ as a therapeutically active ingredient, and that are presented as oral preparations, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods.
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 on 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 on 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 to 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 goods. Part 1 of Schedule 4 does not currently include goods that are oral presentations containing ‘calcified Lithothamnion tophiforme’ as a therapeutically active ingredient.
Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette requiring that specified goods be included in the part of the Register for listed goods. Such notices generally require that goods containing particular ingredients be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of new therapeutic goods that contain ingredients or substances of the kind set out in the notice.
If Part 1 of Schedule 4 to the Regulations is amended to require goods that are the subject of a subsection 9A(5) notice to be included in the part of the Register for listed goods, the notice ceases to have effect (subsection 9A(6) of the Act).
A person can apply for a new ingredient or substance to be specified in a notice under subsection 9A(5). The TGA evaluates such applications, and the supporting data provided by the applicant, on the basis of safety and quality. The safety-focussed element determines whether the ingredient or substance is of sufficiently low risk to allow its inclusion in listed medicines, and the quality-focussed element characterises the precise and correct nature of the ingredient or substance.
CALCIFIED LITHOTHAMNION TOPHIFORME
Lithothamnion tophiforme is a red alga that grows in lower intertidal and subtidal zones of the fjords of Iceland. When it dies, the organism breaks down and settles on the seabed, from where the calcified skeletal remains are harvested. The substance principally consists of carbonates of calcium and magnesium and is intended for use as a calcium supplement for bone health, with particular reference to osteoporosis.
Calcified Lithothamnion tophiforme comprises calcium carbonate (~84%) and magnesium carbonate (~11%). On this basis, it is expected to provide calcium and magnesium supplementation in a manner similar to supplements already included as listed medicines on the Register. In Australia, it is used as a source of calcium in foods such as rice and soy milks. It is also marketed as a dietary multi-mineral/calcium supplement for food enrichment and fortification purposes in Europe, Asia, Australia and North America.
The determination of the safety of calcified Lithothamnion tophiforme was primarily based on the safety of its two main components and the relatively recent history of its safe use in foods both in Australia and overseas. The levels of the numerous trace elements in the substance were also considered and no safety concerns were identified. No quality or safety concerns were identified by the TGA and ‘calcified Lithothamnion tophiforme’ was proposed for use as an active ingredient in orally ingested listed therapeutic goods without restriction.
To that end, the delegate of the Minister has determined that therapeutic goods containing calcified Lithothamnion tophiforme as a therapeutically active ingredient be included in the part of the Register for listed goods when such goods are oral preparations.
The TGA has prepared a physico-chemical description of ‘calcified Lithothamnion tophiforme’ in the form of a draft Compositional Guideline. Compositional guidelines are intended to assist applicants for the listing of therapeutic goods on the Register that are or that include goods of a kind described in a listing notice in identifying the specific forms or types of ingredients or substances where, as in this case, there is no monograph in the British Pharmacopoeia, United States Pharmacopoeia or European Pharmacopoeia in relation to the ingredient or substance in question. This draft Compositional Guideline will be available on the TGA’s website (www.tga.gov.au) for consultation for six weeks following the registration of the Listing Notice on FRLI. The guideline will then be published on the TGA’s website in its final form.
CONSULTATION
Consultation was not undertaken in relation to the making of the Listing Notice, as the notice is considered to be minor and machinery in nature, with low compliance costs for affected industry.
The effect of this Listing Notice is that sponsors wishing to use ‘calcified Lithothamnion tophiforme’ in the formulation of a medicine can list the medicine on the Register rather than registering that medicine. Applications for new registered medicines are fully evaluated by the TGA for quality, safety and efficacy prior to inclusion on the Register, a process that is considerably more expensive and lengthy than the listing process.
The Office of Best Practice Regulation (OBPR) has confirmed that a regulatory impact statement was not required in relation to the Listing Notice (OBPR ref. 14417).
In relation to compatibility with human rights, it is considered that the Listing Notice is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.
ATTACHMENTS
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (Therapeutic Goods (Listing) Notice 2012 (No.4) – calcified Lithothamnion tophiforme).