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CMEC Meeting 17, 10 December 1999

Complementary Medicines Evaluation Committee

10 December 1999

Extracted ratified minutes

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CMEC Meeting 17 extracted ratified minutes (pdf,40kb)

Public recommendation summary

Item 4 Report of the Working Party on Herbal Medicine Issues

CMEC noted and endorsed the approach of the Working Party on Herbal Medicine Issues. CMEC also endorsed the following recommendations of the Working Party to the TGA:

Recommendation 17.1

To amend the entry for Arisaema, in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations, in order to infer that Arisaema preparations at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods, and to omit the reference to preparations containing cardiac glycosides.

Recommendation 17.2

To amend the entry for Arnica in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations, in order to infer that preparations of Arnica used externally, or those used internally at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods.

Recommendation 17.3

That expert advice be sought (eg from the Chair of the former Traditional Medicines Evaluation Committee and other experts) relating to the issues of:

  1. dermal absorption of the toxic component(s) of Daphne mezereum, and whether there is further information (to that available in 1994/5 when TMEC considered this herb) relating to the toxicity of Daphne mezereum; and
  2. possible mechanisms for restricting external dose to a specified amount.

Recommendation 17.4

To amend the entry for Lathyrus sativus in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations to omit the reference to "cooked seed", and to include a reference to preparations containing no lathyrogenic amino acids. The entry is meant to imply that preparations of Lathyrus sativus containing no lathryogenic amino acids AND preparations of Lathyrus sativus at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods.

Recommendation 17.5

To amend the entry for Prunus dulcis entry in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations to omit the reference to preparations containing cyanogenic glycosides. The entry is meant to imply that preparations of Prunus dulcis seed are only eligible for inclusion in listed goods at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose). Preparations of Prunus dulcis containing other plant parts remain eligible for inclusion in listed goods at any dose safe for that ingredient.

Recommendation 17.6

To amend the entry for Pseudolarix kaempferi in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations in order to infer that preparations of the stem bark and root used externally, or preparations of any plant part used internally at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods.

Recommendation 17.7

To amend the entry for Ricinus communis in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations so that it is clear that the fixed oil of the seed ONLY is eligible for inclusion in listed goods.

Recommendation 17.8

To amend the entry for Robinia pseudoacacia in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations in order to infer that preparations of the leaf and flower, or preparations of other plant parts at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods.

Recommendation 17.9

To amend the entry for Semecarpus anacardium in Schedule 4, Part 4(2) of the Therapeutic Goods Regulations in order to infer that preparations of the seed, or preparations of other plant parts at low doses (equivalent to 1mg or less of dry herbal material per recommended daily dose), are eligible for inclusion in listed goods.

Item 5.1.1 Hydroxycitric acid - zinc and magnesium salts

Recommendation 17.10

CMEC advises the TGA that it does not hold any significant concerns related to the safety of zinc hydroxycitrate and magnesium hydroxycitrate additional to those for the hydroxycitrates already approved for listing, noting that the use of zinc salts in listed medicines is subject to the requirements of the Standard for the Uniform Scheduling of Drugs and Poisons. Consistent with its previous recommendation, CMEC advises that solubility data, determined in simulated gastric juice (as per the method outlined in the US Pharmacopoeia), need to be provided before these salts are recommended for use as active ingredients in listable therapeutic goods. If these data are provided, then zinc hydroxycitrate and magnesium hydroxycitrate would be considered for suitability for use in listable therapeutic goods.

Item 6.1 Bovine lactoferrin

Recommendation 17.11

CMEC recommends to the TGA that bovine lactoferrin be accepted as both an active ingredient and an excipient ingredient suitable for use in listable therapeutic goods. Where bovine lactoferrin is used as an active ingredient, the label should advise that the substance is derived from cow's milk. A request for consideration should be made to the Therapeutic Goods Committee that bovine lactoferrin be included in the second schedule to Therapeutic Goods Order No. 48 - General requirements for labels for drug products.

Item 7.1 Valeriana officinalis (valerian)

Recommendation 17.12

CMEC recommends to the TGA that Valeriana officinalis (valerian) appears to be of sufficiently low risk as to continue to be suitable for use in listable therapeutic goods, with no additional restrictions imposed.

Item 7.2 Ginkgo biloba (ginkgo)

Recommendation 17.13

CMEC recommends to the TGA that Ginkgo biloba (ginkgo) appears to be of sufficiently low risk as to continue to be suitable for use in listable therapeutic goods, with no additional restrictions imposed.

Item 8 Registration applications

Recommendation 17.14

CMEC recommended a product for registration.

Item 10.2 Draft compositional guideline for calcium hydroxy methyl butyrate (HMB)

Recommendation 17.16

CMEC advises the TGA that it endorses the draft compositional guideline for calcium hydroxy methyl butyrate and supports its release for broad comment.

Item 10.4 Bioavailability data in registration applications

Recommendation 17.18

CMEC recommends to the TGA that, where a medicine presented for registration is of the same formulation and same form as one for which clinical trials were conducted, then bioavailability data may not be required. However if the medicine is presented in a different form to that used in clinical trials, bioequivalence must be established.

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