Australian herbal remedies being considered by the TGA to be ‘reasonably safe with less adverse reactions than conventional pharmaceutical treatments’ are allowed to enter the register at a lower level than other pharmaceuticals. Herbal products made from starting materials of pharmacopoeial standards, approved by the TGA, with claims within Advertising Code guidelines containing active ingredients prescribed in the regulations receive a LISTING and an AUSTL number. Though a LISTING does not specifically require submission of efficacy or stability data, TGA reserves the right to call for this data.

Listed medicines may only contain ingredients that have been evaluated by the TGA to be low risk. TGA has a list of substances that may be used as active ingredients in listed medicines. The safety of ingredients for use and quality standards for ingredients acceptable to the TGA are given in Therapeutic Goods Order (TGO). The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) contains guidance on the criteria for compositional guidelines which is a summary of descriptions, tests and limits that define the composition and relevant characteristics of the substance. These guidelines have been developed to assist sponsors in determining the appropriate evidence to support indications and claims made in relation to listable medicines. Where the claims/indications do not appear to be consistent with the evidence guidelines, the TGA may request the sponsors to submit full text copies of all relevant reference materials for evaluation. The guidelines offer advice on the levels and kinds of evidence to support claims on therapeutic goods.

According to general requirements for labels of medicines, herbs are included in the list of Australian approved names for pharmaceutical substances which is published by the TGA in its edition ‘TGA Approved Terminology for Drugs’ dated January 1993, with amendments. There are also special regulations in the expression of quantity or proportion of active ingredients in drug products, with special requirements for herbal ingredients. Post-market regulatory activities include targeted and random desk-based audits of listed products, monitoring of adverse reactions to complementary medicines, targeted and random laboratory testing of products and ingredients, targeted and random surveillance in the market place, an effective, responsive and timely recall procedure, audit of GMP, effective controls for the advertising of therapeutic goods, adverse drug reaction reporting and monitoring adverse reactions to complementary medicines. Traditional medicines such as Ayurvedic and Chinese medicines are classified as ‘complementary medicines’ and are generally required to meet the same standards of quality and safety as other modern medicines to meet their legislative obligations. Once a therapeutic claim is made or implied, then the goods become therapeutic and subject to the requirements of the Australian Therapeutic Goods Act 1989.