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Australian Government Enhancing CAM Regs
March 28, 2005
2 Min Read
Australian Government Enhancing CAM Regs
SYDNEY, AustraliaTheAustralian government announced March 9 its Therapeutic Goods Association (TGA)will implement a series of initiatives designed to bolster its regulation ofcomplementary medicines and herbal products. Its announcement was in response torecommendations issued almost 18 months ago by an Expert Committee onComplementary Medicines in the Health System; that committee was formed afterthe April 2003 recall of more than 1,600 dietary supplement products produced byPan Pharmaceuticals. (For more on the original committee report, seewww.naturalproductsinsider.com.) In a forward to the report, Christopher Pyne,parliamentary secretary to the Australian minister for health and aging, notedthe government agreed with the findings of its expert committee on the need forcomplementary medicines and herbal products to meet more rigorous safety andefficacy standards. Australians must have the same level of confidence in thesafety and quality of complementary medicines as they can with their othermedicines, he wrote.
The Australian government accepted nearly all of the committeesrecommendations. Plans include:
Establishing standards of evidence for claims forcomplementary medicines and herbal products.
Increasing regulatory scrutiny of the evidence andmarketing of such products.
Modifying its current reporting formats and databasesearch capabilities for adverse event reporting, as well as encouragingmanufacturers to improve their reporting mechanisms.
Developing an advertising scheme to cover acceptableclaims in both Australia and New Zealand.
Encouraging state and territory governments to introducelegislation to regulate practitioners of alternative medicine.
In its response, the government noted there is need forfurther research into the efficacy of these types of products, and that thereshould be government funding for such research; however, it said no definitiveamounts can be determined until after the needs and priorities for theresearch have been identified. In addition, the government response noted whileits plans are presented for Australia alone, it plans to consult withstakeholders in New Zealand as well, as it still plans to develop a Trans Tasmanregulatory agency with authority similar to the U.S. Food and DrugAdministration (FDA).
The full report is available on the TGA Web site(www.tga.gov.au/cm/cmresponse.htm).
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