Additions to approved listable substances

There will be 23 new Listable substances for 1998 plus the probiotic organisms currently Registrable (grandfathered) once the next amendment is passed. Drawing on advice from the CMEC, the TGA recently approved probiotic organisms currently in grandfathered products and six new substances to be included in Listed products. Look for the announcement in the Commonwealth Gazette of amendments to Schedule 4 of the Therapeutic Goods Regulations to include:

• probiotic bacteria from the genera Lactobacillus and Bifidabacterium, of the same strains and species as have previously been used in grandfathered, registered, non-prescription medicines, included in the Australian Register of Therapeutic Goods (ARTG) as at 31 July 1998
• inulin
• oligofructose
• chitosan
• glucosamine sulphate and glucosamine hydrochloride
• hydroxyapatite

The TGA will be producing information sheets on these new substances, for distribution when the changes to the Regulations take effect. These sheets will outline any particular requirements in relation to the use of these substances. For example, the label of products containing chitosan must carry three statements. First, the label must indicate that chitosan is derived from seafood, to alert consumers who may have seafood allergies. Second, the label must advise that chitosan be taken one hour before any medication, to prevent it binding and reducing the effectiveness of other drugs. Finally, the labels of products containing powdered chitosan must include directions that the powdered chitosan product should be mixed either with fluid or food, and should never to be taken as a dry powder on its own, or similar words. This recommendation is intended to reduce the potential for inhalational irritation

CMEC one year old

The new arrangements for the evaluation of complementary medicines and substances has enabled the TGA to break new ground in providing appropriate regulation for this sector of the industry. The new Complementary Medicines Evaluation Committee (CMEC) has established itself as a credible body of experts well suited to evaluate new complementary medicine substances, after the responsibility was shifted with the Schedule 10 changes. CMEC is ideally positioned to assist expansion and innovation in this important and growing sector of the industry.

The CMEC has met ten times in the last twelve months, giving advice on herbal safety reviews, new Listable active and excipient substances, Registration applications, section 7 declarations that certain goods at the food/drug interface are therapeutic goods and improvements to regulatory policies. The CMEC has also made submissions to the National Drugs and Poisons Scheduling Committee on harmala alkaloids, kava and selenium.

Complementary medicines homepage

The Complementary Medicines Section of TGA receives more than 5000 phone calls annually requesting information on the policies and regulations concerning the manufacture, sale, ARTG Listing and Registration and importation of complementary medicine products in Australia. To assist the flow of information and offer an alternative to phone-based information exchanges, the TGA will enhance its current homepage to include a substantial "Complementary Medicines Page <http://www.tga.gov.au/cm/cm.htm>". The page will aim to provide a user friendly self help system to address the most frequent queries about complementary medicines and to provide access to CMEC/TGA documents available for public release.

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Concentrated ginger products - new condition of listing

A new labelling requirement has come into effect for concentrated ginger products. The CMEC is concerned that highly concentrated ginger products possess a chemical profile which may not be compatible with the assumptions associated with traditional safe use. Adverse reaction reports have been received in association with the highly concentrated form.

Products containing Zingiber officinale in a concentrated form, defined by an extraction ratio of 25:1 or higher and with an equivalent dry weight per dosage unit of 2g and above, will be required to carry the following warnings until such time as there is sufficient evidence in humans that the precautions are not necessary:

This requirement is effective immediately for new products and by 30 January 1999 for existing products, meeting the two criteria above, on the ARTG.

Evaluation of OTC medicines

Following recent amendments to Schedule 10 to the Therapeutic Goods Regulations, some products which were previously evaluated by the Drug Safety and Evaluation Branch can now be evaluated by the OTC Drug Evaluation Unit.

Under the new arrangements, products which are not scheduled as 'prescription only' (ie. included in schedules 4, 8 or 9 to the SUSDP) are evaluated by the OTC route regardless of pack size considerations. In addition, products which are currently classified as 'prescription only' can be evaluated by the OTC route where the sponsor provides an acceptable justification to the TGA. Draft guidelines and procedures for 'justification applications' are currently in use and copies are available from the OTC Drug Evaluation Unit (tel. (02) 6232 8652).

Products containing new substances (whether active or excipient) can now be evaluated by the OTC route where the product meets the National Drugs and Poisons Schedule Committee's criteria for inclusion in an OTC schedule. These criteria are included in the guidelines mentioned above. Copies of the amendments to the Therapeutic Goods Regulations (dated 15 July 1998) are available from Government Information Shops.

These changes will help to ensure that products and substances are evaluated by the most appropriate route without being necessarily restricted by current scheduling arrangements or whether substances are currently being used in Australia.

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Herbal component names

In response to industry requests for a quicker response time for applications for herbal component names (or "HCNs"), the Herbal Ingredient Names Committee (HINC) has been meeting on a monthly basis since March of 1998. This has greatly reduced the time taken to approve HCNs, and as of August 1998 the HINC has procedures in place to reduce this time further where possible.

Further to this, the HINC has recognised the difficulty that sponsors face when attempting to include lengthy HCNs on labels. To help combat this problem, two initiatives have been introduced:

• the Label expressions "calc." or "calc. as" may be used as an alternative to "calculated as" where these words occur as part of a HCN. Please note that "calculated as" will still be required to be included in ARTG applications for Listing.
• in certain cases where approved HCNs are very long, the HINC will consider, on a case-by-case basis, approving an alternative label-HCN. When an alternative label-HCN is approved, the full HCN, known as the ARTG-HCN, should be the entry in the Electronic Lodgement Facility (ELF).

Since the 1995 version of the TGA Approved Terminology for Drugs, the following HCNs have been approved:

• acemannan (of Aloe barbadensis)
• agnuside (of Vitex agnus-castus)
• alantolactone
• alpha-carotene
• alkylamides (of Echinacea angustifolia and E. purpurea)
• andrographolide (of Andrographus paniculata)
• ARTG-HCN "anthocyanins calculated as cyanidin chloride (of Sambucus nigra)"
  • label-HCN "anthocyanins (of Sambucus nigra)"*
• anthocyanosides (of Vaccinium myrtillus)
• asiaticoside (of Centella asiatica)
• aucubin (of Vitex agnus-castus)
• berberine
• beta-1, 2-D-oligofructofuranosides (of Echinacea purpurea)
• biochanin A
• carotenoids calculated as betacarotene (of Dunaliella salina)
• catechins (of Camellia sinensis)
• cichoric acid (of Echinacea purpurea)
• cis-betacarotenes
• cryptoxanthin
• curcuminoids (of Curcuma longa)
• cyanidin
• cyclopentane sesquiterpenes (of Valeriana officinalis)
• daidzein
• daidzin
• delphinidin
• ARTG-HCN "dibenzocyclooctadiene lignans (of Schisandra chinensis)"
  • label-HCN "lignans (of Schisandra chinensis)"*
• diosgenin and dioscin calculated as diosgenin (of Dioscorea villosa)
• ferulic acid
• ferulic and isoferulic acids
• genistein
• genistin
• ginsenosides calculated as Rg1 and Rb1
• ARTG-HCN "ginsenosides Rg1, Re, Rf, Rg2, Rb1, Rb2, Rc, Rd (of Panax ginseng)"
  • label-HCN "ginsenosides (of Panax ginseng)"*
• glycitein
• glycitin
• gymnemic acids (of Gymnema sylvestre)
• hypericin derivatives calculated as hypericin (of Hypericum perforatum)
• hyperoside (of Betula)
• isoferulic acid
• isoflavone glycosides calculated as genistin and daidzin (of Glycine max)
• isoflavones (of Trifolium pratense)
• ARTG-HCN "isoflavones calc daidzin/ein, genistin/ein, glycitin/ein (of Glycine max)"
  • label-HCN "isoflavones (of Glycine max)"*
• kawapyrones (of Piper methysticum)
• ARTG-HCN "lignans calculated as secoisolariciresinol diglucoside (of Linum usitatissimum)"
  • label-HCN "lignans (of Linum usitatissimum)"*
• ligustilide (of Angelica polymorpha)
• malvidin
• oleuropein
• oxindole alkaloids calculated as mitraphylline (of Uncaria tomentosa)
• peonidin
• petunidin
• polyphenols calculated as catechin (of Oenothera biennis)
• procyanidins (of Pinus pinaster)
• procyanidins (of Vitis vinifera)
• purine alkaloids calculated as caffeine (of Paullinia cupana)
• ruscogenin
• sennosides calculated as sennoside B (of Cassia)
• syringaresinol diglucosides (of Eleutherococcus senticosus)
• syringin
• taxifolin (of Pinus pinaster)
• ARTG-HCN "triterpene glycosides calculated as 27-desoxyactein (of Cimicifuga racemosa)"
  • label-HCN "triterpene glycosides (of Cimicifuga racemosa)"*
• ARTG-HCN "valerenic acids calculated as hydroxyvalerenic acid, acetoxyvalerenic acid and valerenic acid (of Valeriana officinalis)"
  • label-HCN "valerenic acids (of Valeriana officinalis)"*
• vinyldithiins (of Allium sativum)
• zeaxanthin

* Label-HCNs may only be used when the approved ARTG-HCN is entered in the Electronic Lodgement Facility (ELF).

The HINC has also updated the application form for HCNs.

National Drugs and Poisons Committee

The National Drugs and Poisons Schedule Committee (NDPSC) Secretariat joined the TGA's Chemicals and Non-Prescription Drugs Branch in mid-1996. The Committee meets four times a year to consider proposals to amend the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The thirteenth version of the SUSDP (the consolidation of SUSDP 12 and its 4 amendments) is now available from Government Information Shops throughout Australia.

The membership of the NDPSC comprises a representative of the Commonwealth (as Chairman) together with representatives of State and Territory health authorities, the TGA, the NRA, the NZ Ministry of Health, the NZ Ministry of Agriculture, industry, pharmacy, consumers and persons with expertise in clinical pharmacology, veterinary medicine/pathology and occupational health.

During 1999 the Committee will meet in Canberra on 16-18 February, 18-20 May, 17-19 August and 16-18 November. In addition to its regular meetings the Committee has established a working party to harmonise the scheduling of Drugs and Poisons between Australia and New Zealand. The working party has held two meetings this year in New Zealand. Scheduling proposals arising from these meetings will be advised by publication in the Gazette and will be open for public consultation before adoption into the SUSDP.

Further information on the NDPSC (including guidelines, Gazette notices, details of publications and meeting dates) is available on the TGA's Internet site <http://www.tga.gov.au/ndpsc/index.htm>.

Other CMS matters

The potentially new Listable substances currently under consideration are coenzyme Q10, hydroxycitric acid, amino acids not currently permitted, betaine HCl and lipoic acid.

The working party attached to the CMEC for Priorities for the Safety Review of Herbs recommends that the following herbs should be reviewed (in order of priority): Gingko biloba, Oenothera ennis oil (evening primrose oil), Valerian officinalis and Paullinia cupana (guarana). These reviews will be conducted to include public comment. Invitations to comment on the safety of Gingko biloba are being issued first.

Invitations to comment on other reviews will be advertised in TGA News and ANZFA News and circulated to industry organisations and other stakeholders.

The CMS continues to receive applications for Registration of complementary medicines which have to be handled as a priority. The details about such applications are Commercial-in-Confidence and decisions about them may only be made public after all negotiations have been finalised with the sponsor. Examples of the types of decisions made about Registrable products will be included in the new Australian Guidelines for the Registration of Drugs (AGRD2).

Should these products be only regulated as therapeutic goods?

Public comment is sought on a number of new proposals for declarations of goods as therapeutic goods, under section 7 of the Therapeutic Goods Act 1989. The External Reference Panel on Interface Matters (ERPIM) held its third meeting in November 1998 and recommended that comment be sought on the following proposals:

1. Goods containing extracted or synthesised hydroxycitric acid or hydroxycitrate, or labelled or promoted as containing hydroxycitric acid or hydroxycitrate
2. Goods containing the fruit of Garcinia species in tincture, powder, capsule, tablet or pill form
3. Goods containing extracted squalene or labelled or promoted as containing squalene, unless packed and labelled for cosmetic use
4. Goods containing isolated creatine which are not standardised under Standard R10 - Formulated Supplementary Sports Foods
5. Goods containing propolis, unless packed and labelled for cosmetic use

Comments close on 12 February 1999.