Abstract

This paper provides a brief overview of how complementary medicines are regulated in Australia and of important new developments occurring in the regulatory environment. Following wide-ranging reforms in governmental regulation in the area of complementary medicines in the late 1990s, which were premised on the emerging recognition of roles they can play in healthcare, progress toward greater acceptance and use of these medicines has continued at an increasing pace. Not only has this meant greater numbers of consumers and healthcare practitioners embracing complementary medicines but it has also posed significant challenges for the regulatory framework which operates for medicines in Australia. The regulatory framework for complementary medicines in Australia In Australia, medicines are regulated federally by the Therapeutic Goods Administration (TGA), which is a statutory body included within the Australian Governments health portfolio. The TGA is responsible for administering the provisions of the Therapeutic Goods Act of 1989. The overall objective of the act is to ensure the quality, safety, efficacy and timely availability of therapeutic goods, including medicines, supplied in or exported from Australia. The TGA regulates many of the finished medicine products presented for commercial sale and then prescribed by some healthcare therapists but has no responsibility for how such therapists are regulated or the interventions they use, these tending to be more matters of State jurisdictions. Included among the types of medicines regulated by the TGA are complementary medicines which include herbal medicines, vitamin, mineral and nutritional supplements, traditional medicines such as Ayurvedic medicines and traditional Chinese medicines (TCM), homoeopathic medicines and aromatherapy oils.