The regulation of complementary medicines by the Therapeutic Goods Administration
- Helen Cameron
- Aust Prescr 1998;21:107-8
- 1 October 1998
- DOI: 10.18773/austprescr.1998.101
Complementary medicines are regulated by the same legislation as orthodox medicines, with the same objective of controlling the supply of quality, safe and efficacious medicines in Australia. In recognition of the differences posed by the nature of complementary medicines and the market in which they are sold, there are different administrative arrangements for their evaluation. The Government is now advised by the new Complementary Medicines Evaluation Committee.
The use of alternative or complementary medicines is increasing and they are prescribed or recommended by both orthodox and alternative practitioners. Importantly, they are also self-prescribed following self-diagnosis by consumers. We are in an era of development of novel alternative medicines, with a huge proliferation of products available to the consumer. These changes in the marketplace need to be reflected in the regulation of such medicines.
In 1997, the Parliamentary Secretary to the Minister for Health and Family Services established a new Ministerial advisory committee, the Complementary Medicines Evaluation Committee (CMEC). This advises the Therapeutic Goods Administration (TGA) and the Government on the regulation of complementary medicines.
The TGA is including a new Schedule in the Therapeutic Goods Regulations to define the huge variety of complementary medicines. The Schedule includes vitamins and minerals, plant and animal derived material, food components such as sugars and mucopolysaccharides, bee products and charcoal. Products containing substances listed in this new Schedule are regulated under the same system as orthodox medicines and, thus, have to be included in the Australian Register of Therapeutic Goods (ARTG).
An exemption from the requirement to be included in the ARTG is given for medicines extemporaneously compounded for a particular person. A herbalist may prepare a medicine from raw herbs for a particular client's needs, and legally dispense this to the client. A herbalist is not permitted, however, to supply Scheduled poisons.
A complementary medicine, based on the same criteria as other therapeutic goods, may be either listable or registrable in the ARTG. Complementary medicines range from those which are safe for widespread use to those containing Scheduled poisons. They are regulated accordingly.
Listable complementary medicines
These products may only contain substances generally regarded as safe, and may only carry claims for the temporary relief of minor self-limiting conditions. Listable products are not assessed for efficacy before entry, but sponsors should hold data to support any claims made. These products need to comply with relevant statutory standards and must also meet requirements, such as labelling requirements, advertising regulations and compliance of the manufacturing process with a recognised code of good manufacturing practice (GMP). Many herbal preparations fit into this listable category and are thus available in pharmacies and health food stores for consumer self-selection.
Listable complementary products may be formulated from any of the herbal substances, vitamins, minerals and chemical substances permitted according to Schedule 4 of the Therapeutic Goods Regulations. These ingredients may be used in any combination and generally in any amount. For example, there are hundreds of echinacea products in the ARTG in many different formulations, alone, or in combination with several herbs or with vitamins and minerals.
Registrable complementary medicines
These products have to be evaluated for safety, quality and efficacy, as do orthodox medicines, before inclusion in the ARTG. However, different kinds of evidence, such as traditional use or epidemiological data, may be taken into account in their evaluation. A product will be registrable if it carries a claim that it can cure or prevent a disease or has an indication for a serious condition. Products with new substances are regarded as registrable until they are evaluated as generally safe.
Registrable products may be available for supply over the counter, pharmacy only or prescription only. Currently, only registered medical practitioners may prescribe Schedule 4 medicines. The recognition of other health professionals for authorisation to write prescriptions is a State and Territory matter. The possible registration of practitioners of Chinese medicine is being reviewed by the Victorian Government.
A complementary medicine may be regulated as a non-prescription registrable product when regarded as higher risk than a listed product, possibly for safety reasons due to a particular ingredient. For example, there are 3 species of the herb Ipomoea (morning glory) which are registrable for safety reasons, while the tuberous root of Ipomoea batatas (sweet potato) is listable. Alternatively, the total formulation may need a registration evaluation because of the indications for the product. Oral rehydration for the treatment of severe diarrhoea is an example of an indication which may suggest registration as the best approach.
Practitioners are encouraged to become aware of their patients' use of complementary medicines. Adverse reactions to complementary medicines and interactions with orthodox medicines should be reported to the Adverse Drug Reactions Advisory Committee.
Acting Secretary, Complementary Medicines Evaluation Committee, Therapeutic Goods Administration, Canberra