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CMEC Meeting 26, 23 March 2001
Complementary Medicines Evaluation Committee
Extracted ratified minutes
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.
CMEC confirms that the draft Minutes of its previous meeting (CMEC 25, 2 February 2001), as amended, are a true and accurate record of that previous meeting.
Item 3 Guidelines on levels and kinds of evidence to support claims for therapeutic goods ('Guidelines')
CMEC endorsed the revised Guidelines (March 2001 version), incorporating a simplified Executive Summary and a glossary, and recommended some minor revisions.
CMEC recommends to the TGA that the substance Streptococcus thermophilus is suitable for use as an active ingredient in listable therapeutic goods, subject to the use of an appropriate compositional guideline.
CMEC recommends to the TGA that the substance Morinda citrifolia fruit juice is suitable for use as an active ingredient in listable therapeutic goods. However the committee noted that, based on evidence obtained through the literature search strategy used, there does not appear to be any evidence to support indications relating this herbal substance to immune support.
CMEC recommends to the TGA that Pseudowintera colorata leaf is suitable for use in listable therapeutic goods.
CMEC recommends to the TGA that the substance 'demineralised proteoglycans' is suitable for use in listable therapeutic goods, subject to finalisation of certain naming and quality issues.
CMEC made a recommendation in relation to registration of a complementary medicine.
CMEC recommends to the TGA that directions for use for all age groups are not required for listed medicines and, where product labels include only recommended adult doses, statements such as "adults only" or "not recommended for children" need not be included.
|CMEC 26 Extracted Ratified Minutes (pdf)||49KB|