The regulation of herbal medicines in Australia.
Complementary medicines, including herbal medicines in Australia are regulated under therapeutics goods legislation. Based on risk, Australia has developed a two tiered approach to the regulation of therapeutic goods. Listed medicines are considered to be of lower risk than Registered medicines. Most, but not all, complementary medicines are Listed medicines. Managing the risk associated with therapeutic goods, including complementary medicines, is exerted through the processes of licensing of manufacturers; pre-market assessment of products; and post-market regulatory activity. Herbal medicines may be associated with low or high risk depending on the toxicity of ingredients, proposed dosage, appropriateness of the indications and claims for self-diagnosis and management and the potential for adverse reactions. Registered medicines are individually evaluated for safety, quality and efficacy before they are released onto the market. Listed medicines are individually assessed by the Therapeutic Goods Administration for compliance with legislation, they are not evaluated before release. They may only be formulated from ingredients that have undergone pre-market evaluation for safety and quality and are considered low risk. Listed complementary medicines may only carry indications and claims for the symptomatic relief of non-serious conditions, health maintenance, health enhancement and risk reduction. An important feature of risk management in Australia is that early market access for low risk complementary medicines is supported by appropriate post-market regulatory activity.
Briggs
David R
DR
Office of Complementary Medicines, Therapeutic Goods Administration, P.O. Box 100, 2609 Woden, ACT, Australia. david.briggs@health.gov.au
D001315:Australia; D004341:Drug Evaluation; D004345:Drug Industry / Q000331:legislation & jurisprudence; D029001:Herbal Medicine / Q000331:legislation & jurisprudence*; D006801:Humans; D007880:Legislation, Drug / Q000639:trends*; D008004:Licensure; D028321:Plant Preparations / Q000009:adverse effects / Q000627:therapeutic use* / Q000633:toxicity; D011358:Product Surveillance, Postmarketing; D012308:Risk Management
D028321:Plant Preparations