EXPLANATORY STATEMENT
THERAPEUTIC GOODS (LISTING) NOTICE 2015 (NO. 2)
Subsection 9A(5), Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods (Listing) Notice 2015 (No.2) (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 is a legislative instrument and has the effect of requiring that the following therapeutic goods, subject to specified conditions, be included in the part of the Australian Register of Therapeutic Goods (the Register) for listed goods, instead of being included as registered goods:
(a) preparations that contain as their therapeutically active ingredient, citric acid anhydrous or citric acid monohydrate;
(b) preparations that contain as their therapeutically active ingredient, sodium monofluorophosphate, in combination with at least one other therapeutically active ingredient referred to in Item 3 of Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990 (the Regulations), subject to specified requirements;
(c) preparations, for oral use, that contain as their therapeutically active ingredient whole dried Undaria pinnatifida, excluding the holdfast;
(d) preparations, for oral and topical use, that contain as their therapeutically active ingredient, conifer green needle complex, that are made by petroleum ether extraction of needles from two conifer species consisting of Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce);
(e) preparations, for oral use, that contain as their therapeutically active ingredient, Trametes versicolor proteoglycan concentrate.
This Listing Notice revoked five legislative instruments made under subsection 9A(5) of the Act (revoked Listing Notices) that are due to sunset on the following dates: 1 October 2015 or 1 April 2016. This Listing Notice has the effect of allowing the above specified therapeutic goods to continue to be included in the part of the Register for listed goods, subject to specified conditions, beyond the sunsetting date for the revoked Listing Notices, from commencement of this Listing Notice.
The revoked Listing Notices consist of the following:
(a) Therapeutic Goods (Listing) Notice 2005 (No. 5);
(b) Therapeutic Goods (Listing) Notice 2005 (No. 6);
(c) Therapeutic Goods (Listing) Notice 2006 (No. 1);
(d) Therapeutic Goods (Listing) Notice 2006 (No. 2); and
(e) Therapeutic Goods (Listing) Notice 2006 (No. 3);
This 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), part of the Department of Health, is responsible for administering the Act.
Unless specifically exempted from the requirement for inclusion in the Register or authorised or approved under the Act, therapeutic goods are required to be included in 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 relevant part of the Register under Part 3-2 of the Act, depending on the therapeutically active ingredients they contain and the therapeutic claims that are being made.
In general, products that contain low risk therapeutically active ingredients are required to be included in the Part of the Register for listed medicines in Australia, 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 therapeutically active 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 Regulations provides a list of those therapeutic goods (including specified therapeutically active ingredients and limitations applying to those ingredients) that are required to be included in the part of the Register for listed goods. Part 1 of Schedule 4 does not currently include the therapeutic goods that are the subject of this Listing Notice.
Subsection 9A(5) of the Act authorises the Minister for Health to publish a notice in the Commonwealth of Australia Gazette or on the Department’s website requiring that specified therapeutic goods be included in the part of the Register for listed goods, and specify the conditions subject to which such goods may be included in the Register. Such notices generally require that goods containing particular therapeutically active ingredients to be included in that part of the Register. Once the notice is in effect, persons may apply for the listing on the Register of therapeutic goods that contain therapeutically active ingredients or specified substances 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 changes to certain conditions associated with an ingredient 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.
Therapeutic goods containing specified therapeutically active ingredients covered by this Listing Notice
(a) Citric acid anhydrous and Citric acid monohydrate
The Therapeutic Goods (Listing) Notice 2005 (No. 5) (Listing Notice 2005 (No. 5)), an instrument made under subsection 9A(5) of the Act by the delegate of the Minister for Health, authorised the listing of therapeutic goods that are preparations containing as their therapeutically active ingredient, citric acid anhydrous or citric acid monohydrate. Listing Notice 2005 (No. 5) was due to sunset on 1 October 2015 and has been revoked by this Listing Notice prior to its sunset date of 1 October 2015. Both citric acid anhydrous and citric acid monohydrate have been permitted for use as therapeutically active ingredients in listed medicines since 2005 as a result of the above Listing Notice.
They have been permitted for use as (excipient) ingredients in listed medicines for many years and are also included as active ingredients in a number of registered medicines entered on the Register.
Citric acid is used extensively in foods such as soft drinks. A typical expected daily dietary intake is around 300 milligrams per kilogram of body weight per day. A literature-based review found that citric acid did not result in adverse effects at the upper end of doses experienced in everyday use (around 500 milligrams per kilogram of body weight per day).
The TGA has not received any reports of adverse events that would suggest that these ingredients used as therapeutically active ingredients are unsafe.
To that end, the delegate of the Minister has determined that therapeutic goods that are preparations containing ‘citric acid anhydrous or citric acid monohydrate’ as therapeutically active ingredients continue to be included in the part of the Register for listed goods. This decision is reflected in this Listing Notice which allows any of these substances to continue to be used as therapeutically active ingredient in listed medicines.
(b) Sodium monofluorophosphate
The Therapeutic Goods (Listing) Notice 2005 (No. 6) (Listing Notice 2005 (No. 6)), an instrument made under subsection 9A(5) of the Act by the delegate of the Minister for Health, authorised the listing of therapeutic goods that are preparations containing as their therapeutically active ingredient, sodium monofluorophosphate, in combination with at least one therapeutically active ingredient referred to in Item 3 of Part 1 of Schedule 4 to the Regulations, subject to specified conditions. Listing Notice 2005 (No. 6) was due to sunset on 1 April 2016 and has been revoked by this Listing Notice.
Sodium monofluorophosphate is a source of fluoride that is widely used in toothpaste products at up to 1000 mg/kg without evidence of safety concerns.
For the above preparation to be a listable medicine, the sodium monofluorophosphate is subject to the following conditions:
- the concentration of the fluoride ion is not more than 1000 mg/kg;
- the substance is for use only in pastes, powders or gels for the cleaning of teeth; and
- any claims made in relation to fluoride content are restricted to those relating to improvements in oral hygiene or the use of fluoride for the prevention of tooth decay.
The TGA has not received any reports of adverse events that would suggest that the therapeutically active ingredient “sodium monofluorophosphate”, satisfying the above requirements, is unsafe.
To that end, the delegate of the Minister has determined that therapeutic goods that are preparations containing ‘sodium monofluorophosphate’ as a therapeutically active ingredient, in combination with specified therapeutically active ingredients listed in Item 3 of Part 1 of Schedule 4 to the Regulations continue to be included in the part of the Register for listed goods, subject to the above conditions. This decision is reflected in this Listing Notice that allows sodium monofluorophosphate, subject to the specified conditions, to continue to be used as a therapeutically active ingredient in listed medicines.
(c) whole dried Undaria pinnatifida, excluding the holdfast, for oral use
The Therapeutic Goods (Listing) Notice 2006 (No. 1) (Listing Notice 2006 (No. 1)), an instrument made under subsection 9A(5) of the Act by the delegate of the Minister for Health, authorised the listing of therapeutic goods that are preparations, for oral use, that contain as their therapeutically active ingredient, whole dried Undaria pinnatifida, excluding the holdfast. Thus whole dried Undaria pinnatifida, excluding the holdfast has been a therapeutically active ingredient of listed medicines since 2006. Listing Notice 2006 (No. 1) was due to sunset on 1 April 2016 and has been revoked by this Listing Notice.
Undaria pinnatifida is a brown marine alga, native to temperate coastal regions of Japan, Korea and China. It has spread, most likely via ship ballast water, to France, New Zealand and Australia, where it is considered to be a marine pest.
Undaria pinnatifida has been an important part of the diet in Japan, Korea and China for centuries, in both raw and cooked forms. It also has a long history of use in traditional medicines in these countries. In Japan, Undaria pinnatifida is used for hypertension, atherosclerosis, liver complaints and cancer. It is also one of three species of brown algae which may be used in the traditional Chinese medicine “Kunbu”, which is used for a range of conditions, including goitre, tumour, oedema, testicular pain and swelling, beri-beri, urinary infection, sore throat and scrofula (a tuberculous infection of the skin and neck). The long history of use of Undaria pinnatifida as a food and a traditional medicine supported its safety and suitability for use as an active ingredient in listed medicines for oral use.
The TGA has not received any reports of adverse events that would suggest that these ingredients are unsafe.
To that end, the delegate of the Minister has determined that therapeutic goods that are preparations containing whole dried ‘Undaria pinnatifida’, excluding the holdfast, as a therapeutically active ingredient continue to be included in the part of the Register for listed goods, when the preparation is for oral use. This decision is reflected in this Listing Notice that allowed preparations containing this therapeutically active ingredient, for oral use, to continue to be used in listed medicines.
(d) Conifer green needle complex for oral and topical use
The Therapeutic Goods (Listing) Notice 2006 (No. 2) (Listing Notice 2006 (No. 2)), an instrument made under subsection 9A(5) of the Act by the delegate of the Minister for Health, authorised the listing of therapeutic goods that are preparations, for oral and topical use, that contain as their therapeutically active ingredient, conifer green needle complex that are made by petroleum ether extraction of needles from two conifer species, Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce). Thus preparations containing this conifer green needle complex as therapeutically active ingredients have been used in listed medicines for oral and topical use since 2006. Listing Notice 2006 (No. 2) was due to sunset on 1 April 2016 and has been revoked by this Listing Notice prior to its sunsetting date.
Conifer green needle complex is a mixture of various compounds made by petroleum ether extraction from the needles of the two conifer species described above.
Conifer green needle complex has a relatively long history of therapeutic use in the former USSR, and more recently in Russia and Latvia. Early therapeutic uses of the material were for the treatment of wounds and burns, and as an ingredient in medicated tampons and cosmetics and products such as toothpastes, soaps and shaving creams.
The long history of use of conifer green needle complex and its low propensity for producing adverse reactions both in oral and topical use supported its safety and suitability for use as a therapeutically active ingredient in listed medicines for oral and topical use.
The TGA has not received any reports of adverse events that would suggest that the ingredient is unsafe.
To that end, the delegate of the Minister has determined that therapeutic goods that are preparations containing ‘conifer green needle complex’ as a therapeutically active ingredient to continue to be included in the part of the Register for listed goods, when the preparations are for oral and topical use. This decision is reflected in this Listing Notice.
(e) Trametes versicolor proteoglycan concentrate
The Therapeutic Goods (Listing) Notice 2006 (No. 3) (Listing Notice 2006 (No. 3)), an instrument made under subsection 9A(5) of the Act by the delegate of the Minister for Health, authorised the listing of therapeutic goods that are preparations, for oral use, that contain as their therapeutically active ingredient, Trametes versicolor proteoglycan concentrate. This proteoglycan concentrate has been a therapeutically active ingredient of listed medicines for oral use since 2006. Listing Notice 2006 (No. 3) was due to sunset on 1 April 2016 and has been revoked by this Listing Notice prior to its sunsetting date.
“Trametes versicolor proteoglycan concentrate” is a concentrated dry hot-water extract of the filaments that make up the body of the edible fungus, Trametes versicolor. Trametes versicolor has a long traditional use in both Chinese and Japanese medicine for a range of ailments.
Trametes versicolor extracts have low toxicity in animals, with very few published adverse effects in humans.
“Trametes versicolor proteoglycan concentrate” is chemically equivalent to “Trametes versicolor hyphae aqueous extract – powder form”, which is also used as a therapeutically active ingredient for use in listed medicines. The latter is listed in Division 2 of Part 4 of Schedule 4 to the Regulations (herbal substances which can be used as a therapeutically active ingredient in listed medicines subject to the qualifications), for the purposes of paragraph (d) of Item 3 of that Schedule.
The long history of use of Trametes versicolor as a traditional medicine supported the safety and suitability of “Trametes versicolor proteoglycan concentrate” for use as a therapeutically active ingredient in listed medicines for oral use.
The TGA has not received any reports of adverse events that would suggest that the ingredient is unsafe.
To that end, the delegate of the Minister has determined that therapeutic goods that are preparations containing ‘Trametes versicolor proteoglycan concentrate’ as a therapeutically active ingredient to continue to be included in the part of the Register for listed goods, when the preparations are for oral use. This decision is reflected in this Listing Notice.
CONSULTATION
Consultation was not undertaken in relation to the making of this Listing Notice, as the specified preparations containing specified therapeutically active ingredients, subject to conditions, were the subject of Listing Notices made under subsection 9A(5) that had legal effect for nearly ten years and were due to sunset on 1 October 2015 or 1 April 2016. Sponsors of therapeutic goods containing those specified preparations (consistent with the conditions attached to those preparations) had included or can apply under section 26A of the Act to include those goods in the part of the Register for listed goods. The making of those Listing Notices that have been revoked by this Listing Notice, had involved consultation.
The making of this Listing Notice does not involve any new regulatory steps for industry, but rather provides a basis for therapeutic goods that are preparations containing the specified therapeutically active ingredients to be eligible for listing rather than registration, a significant benefit for sponsors.
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact statement is not required in relation to Listing Notices (OBPR Ref. 14416).
The effect of this Listing Notice is that sponsors wishing to use the specified preparations containing specified therapeutically active ingredients as set out in this Listing Notice as part of a formulation of a medicine can continue to list the medicine on the Register rather than register 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.
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 set out below.
SUPPLEMENTARY MATERIAL – STATEMENT OF COMPATIBILITY FOR A LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS ISSUES
Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
Therapeutic Goods (Listing) Notice 2015 (No. 2)
This legislative instrument 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.
Overview of the Legislative Instrument
Therapeutic Goods (Listing) Notice 2015 (No. 2) (the 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 effect of the Notice is to allow sponsors of therapeutic goods that are specified preparations containing specified therapeutically active ingredients to continue to list, rather than register, those goods in the Australian Register of Therapeutic Goods (the Register) (registration being a considerably more expensive and lengthy process than listing). Once the Notice has commenced, persons can apply to list therapeutic goods containing these therapeutically active ingredients on the Register.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human rights issues.
John Skerritt, delegate of the Minister for Health