An overview of the regulation of complementary medicines in Australia | Therapeutic Goods Administration (TGA)
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 (link is external) (the Act).
A complementary medicine is defined in the Therapeutic Goods Regulations 1990 (link is external) 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:
an amino acid
charcoal
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.