An overview of the regulation of complementary medicines in Australia
In Australia, medicinal products containing such ingredients as herbs, vitamins, minerals, nutritional supplements, homoeopathic and certain aromatherapy preparations are referred to as 'complementary medicines' and are regulated as medicines under the Therapeutic Goods Act 1989 (the Act).
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 as a therapeutic good consisting principally of one or more designated active ingredients mentioned in Schedule 14 of the Regulations, each of which has a clearly established identity and traditional use:
Designated active ingredients
- an amino acid
- a choline salt
- an essential oil
- plant or herbal material (or a synthetically produced substitute for material of that kind), including plant fibres, enzymes, algae, fungi, cellulose and derivatives of cellulose and chlorophyll
- a homeopathic preparation
- a microorganism, whole or extracted, except a vaccine
- a mineral including a mineral salt and a naturally occurring mineral
- a mucopolysaccharide
- non human animal material (or a synthetically produced substitute for material of that kind) including dried material, bone and cartilage, fats and oils and other extracts or concentrates
- a lipid, including an essential fatty acid or phospholipid
- a substance produced by or obtained from bees, including royal jelly, bee pollen and propolis
- a sugar, polysaccharide or carbohydrate
- a vitamin or provitamin
Australia has a risk-based approach with a two-tiered system for the regulation of all medicines, including complementary medicines:
- Lower risk medicines can be listed on the Australian Register of Therapeutic Goods (ARTG).
- Higher risk medicines must be registered on the ARTG.
Some complementary medicines are exempt from the requirement to be included on the ARTG, such as certain preparations of homoeopathic medicines.
The Australian Regulatory Guidelines for Complementary Medicines (ARGCM) provides detail on the regulation of complementary medicines and assist sponsors to meet their legislative obligations.
TGA post-market regulatory activities relate to the monitoring of the continuing safety, quality and efficacy of listed, registered and included therapeutic goods once they are on the market. Information on the TGA's approach to managing compliance risk is available at: TGA regulatory framework. The TGA Office of Manufacturing Quality inspects manufacturers on an ongoing basis for compliance with good manufacturing practice.
The TGA also undertakes Listed complementary medicine compliance reviews.
Sometimes medicines, including complementary medicines, have unexpected and undesirable effects. The TGA has a strong pharmacovigilance program, which involves the assessment of adverse events that are reported to the TGA by consumers, health professionals, the pharmaceutical industry, international medicines regulators or by the medical and scientific experts on TGA advisory committees.
If you experience an adverse event to a complementary medicine, you should seek advice from a health professional and then report the adverse event to the TGA.
Sponsors of medicines are required to report to the TGA suspected adverse reactions for their medicines that they are aware of. Guidance for sponsors is provided in 'Australian requirements and recommendations for pharmacovigilance responsibilities of sponsors of medicines'.
The marketing and advertising of therapeutic goods, including complementary medicines, is to be conducted in a manner that promotes the quality use of the product, is socially responsible and does not mislead or deceive the consumer.
The advertising of therapeutic goods in Australia is subject to the advertising requirements of the Therapeutic Goods Act, which adopts the Therapeutic Goods Advertising Code (TGAC) and the supporting Regulations, the Trade Practices Act 1975 and other relevant laws.
Anyone may lodge a complaint about an advertisement for therapeutic goods and all complaints are treated in confidence. Refer to 'Making a complaint about the advertising of a therapeutic product'.
Products available on international websites are not regulated by the TGA. The TGA advises that consumers do not order medicines, including dietary supplements and herbal preparations, over the Internet unless you know exactly what is in the preparation and have checked the legal requirements for importation and use in Australia. For more information refer to: Buying medicines and medical devices over the Internet.