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CMEC Meeting 10, 9 December 1998
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
CMEC recommends that NDPSC be advised that there are no current legitimate uses of colloidal silver; and that the Surveillance Section of TGA be requested to investigate the illegal availability of colloidal silver products because of their significant toxicity.
Item 4.1 Honey
CMEC recommends that honey complying with the 1993 British Pharmacopoeia monograph is suitable for use in listable therapeutic goods, with the following labelling requirements for purified honey:
- That the presence of honey is declared on the product label, whether or not it is an active ingredient; and
- That goods for oral use carry a statement that they are not suitable for use in infants under the age of 12 months.
CMEC recommended that lemon-scented tea tree (Leptospermum petersonii) oil be accepted as an excipient for topical application only, at a maximum concentration of 1%, subject to the sponsor being requested to supply details of gas chromatography test methods used, and validation data in support of the test methods.
CMEC recommended that consideration of Item 4.3 (coenzyme Q10 evaluation as a new substance for listing) be postponed until further safety data are obtained and evaluated; and that coenzyme Q10 continues to have high priority for CMEC consideration.
Item 6.1 Coenzyme Q10
CMEC recommended that consideration of Item 6.1 (registration application for coenzyme Q10) be postponed until further efficacy and safety data are obtained and evaluated.
CMEC recommended the product be approved for registration:
- with a tentative shelf life of 3 years, subject to the sponsor providing further stability test data; and
- with a label statement to the effect that the approved indication is for direct application to the gums or teeth, and not for use in an oil burner.
CMEC recommended that the glucosamine hydrochloride product be approved for registration, provided that TGA is satisfied that:
- deficiencies in quality standards are rectified and dissolution data is presented for the dose form to be marketed; and
- either the product is supplied in 500-mg capsules similar to those used in the clinical trial, or comparative dissolution data for the 500 and 750-mg capsules shows that the two dose forms have similar dissolution characteristics.
Alternatively, CMEC recommended that the sponsor rectify deficiencies in quality standards and apply for listing of glucosamine.
CMEC recommended that its proposed wording of the section 7 declaration on shark cartilage be retained as:
Shark cartilage in forms such as powders, capsules, tablets and pills.
and not be changed, as suggested by the External Reference Panel on Interface Matters (ERPIM), to:
Shark cartilage as capsules, tablets and pills and as powders when labelled and promoted for therapeutic use.
CMEC recommended that if sponsors are to claim that products are sustained-release products, they must submit appropriate supporting data. As a minimum requirement, this would comprise comparative dissolution data with an immediate-release formulation. In addition, therapeutic claims made in relation to sustained release must be substantiated.
CMEC recommended that the Complementary Medicines Section investigate sustainedrelease products on the market and address the issue of the need for sponsors to substantiate this claim.
|CMEC 10 Extracted Ratified Minutes (pdf)||46KB|