You are here
The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.
CMEC Meeting 43, 28 November 2003
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 42, 26 September 2003), as amended, are a true and accurate record of that previous meeting.
CMEC recommends to TGA that products containing pancreatic enzyme extract of porcine origin are suitable for use as an ingredient in listable or registrable complementary medicines, for indications other than pancreatic exocrine enzyme insufficiency, subject to the following regulatory approach:
- that TGA consult further with industry on the most appropriate method for reducing the potential of PPV infectivity in porcine pancreatic enzyme extracts, and on a practical timeframe for introducing any new requirements, and report back to CMEC. (CMEC considers that this implementation timeframe should be no more than twelve months.); and
- following the agreed implementation period, sponsors should either:
- ensure that manufacturers of porcine pancreatic extract-containing products validate their manufacturing process for porcine virus inactivation, and if necessary, introduce additional steps for viral inactivation. If gamma irradiation or other steps are introduced, the effect of such step(s) on enzyme activity should be investigated); or
- obtain TGA pre-clearance for PPV by providing adequate data or certification to ensure that pancreatic glands are only collected from pigs that are negative for PPV antibodies and that there have been no reproductive problems in the herds from which the glands are harvested.
CMEC recommends to TGA that the ethyl acetate extract of Commiphora mukul oleo-gum resin is not suitable for use as an ingredient in listed medicines.
CMEC recommends that the TGA conducts a literature survey on the actions of Echinacea with a view to determining any risks associated with its immunomodulatory effects in immune function disorders or conditions.
CMEC recommends that the TGA incorporates into its post-market monitoring program the testing of the quality of a random sample of listed Echinacea products based on currently accepted markers for herbal quality and/or efficacy, and against appropriate quality standards.
|CMEC 43 Extracted Ratified Minutes (pdf)||95KB|