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CMEC Meeting 23, 13 October 2000

Complementary Medicines Evaluation Committee

13 October 2000

Extracted ratified minutes

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CMEC Meeting 23 extracted ratified minutes (pdf,41kb)

Public recommendation summary

This summary has been posted immediately after the CMEC meeting to give quick advice of the recommendations made by CMEC to the TGA. This summary does not represent the decisions of TGA. Reasons underlying these recommendations will be available after Members ratify the Minutes at the next CMEC meeting.

Item 2 Confirmation of draft minutes of CMEC 22

Recommendation 23.1

CMEC confirms that the draft Minutes of its previous meeting (CMEC 22) are a true and accurate record of that previous meeting.

Item 3 Guidelines for levels and kinds of evidence to support claims for therapeutic goods

Recommendation 23.2

CMEC endorsed the 25 September 2000 draft of the Guidelines for levels and kinds of evidence to support claims for therapeutic goods with minor modifications.

Item 4 Final report of the Working Party on Herbal Medicines Issues

Recommendation 23.3

CMEC adopted the final report of the Working Party on Herbal Medicines Issues subject to minor amendments.

Item 6.1 Glutamic acid

Recommendation 23.5

CMEC recommended that the L-isomers of glutamic acid, glutamic acid hydrochloride, and the monoammonium, calcium, magnesium, monosodium and monopotassium salts are suitable for use in listable therapeutic goods.

Item 10.5 CMEC - Principles of operation

Recommendation 23.8

CMEC recommended further information be added to the draft document, CMEC - Principles of operation, including principles for consideration of out-of-session papers, and conflict of interest guidelines.

Item 10.6 Industry request for exemption from warning statements for all homoeopathic products

Recommendation 23.9

CMEC recommended that the industry be requested to provide examples of exemptions from warning statements they are seeking for specific substances used in homeopathic medicines. Consideration should be given to justifying the proposal, for example with reference to the inherent toxicity, dilution and dosage regimen for each substance.

Item 10.7 Report from the Adverse Drug Reactions Advisory Committee (ADRAC)

Recommendation 23.10

CMEC noted the report from ADRAC and requested further information on one case report.

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