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CMEC Meeting 15, 24 September 1999
Complementary Medicines Evaluation Committee
Extracted ratified minutes
Public recommendation summary
CMEC accepted the principle that generic evidence can be used to support claims for the efficacy of registered complementary medicines, provided that sponsors are able to demonstrate that their product is of equivalent formulation and bioactivity.
CMEC did not recommend a variation to a currently registered product as sought by the sponsor.
CMEC recommends to the TGA that the Australian Register of Therapeutic Goods should hold information on the plant name, plant part, extraction process and extraction ratio (or equivalent dry weight) of herbal substances used in therapeutic goods.
CMEC further recommends that a working group be established to consider the broader issues relating to the regulation of herbal substances and products by the TGA.
CMEC recommends to the TGA that no label advisory statement in regard to any effect of squalene on cholesterol levels is necessary when squalene is used as an ingredient in listable therapeutic goods.
CMEC endorses, for consultation purposes, the document "Draft TGA policy statement on the listing of sustained release multivitamin/mineral/herbal products".
CMEC recommends to the TGA that Schedule 4, part 5 of the Therapeutic Goods Regulations be amended to delete the existing words "Bacterial strains from the genera Lactobacillus and Bifidobacterium (other than Bifidobacterium dentium) present in registered goods on 31 July 1998" and substitute the words to the following effect:
"Bacterial strains from the genera Lactobacillus and Bifidobacterium, other than strains of Lactobacillus catenaformis, Lactobacillus uli and Bifidobacterium dentium."
CMEC recommends to the TGA that it does not permit the use in listable therapeutic goods of Bacillus coagulans and Streptococcus thermophilus, at this time. However CMEC will consider applications relating to these bacteria, on a case-by-case basis.
CMEC recommends to the TGA that it does not permit the use in listable therapeutic goods of Enterococcus faecalis.
CMEC endorses the draft criteria for evaluating new probiotic bacteria for use in listable therapeutic goods, with minor amendments.
CMEC recommends to the TGA that there is insufficient evidence, at this time, of adverse consequences associated with the use of creatine and its salts to require any restrictions on dosage and therefore recommends that the current daily dose limit of 3 g should be removed. However CMEC recommends that a label advisory statement to seek professional advice before long term use should be required.
|CMEC 15 Extracted Ratified Minutes (pdf)||30KB|