Accommodating Evidence of Traditional Use for Medicines Within Risk-Based Regulation in Australia

For reasons including affordability, accessibility, cultural heritage and health benefits, traditional medicines are still important contributors to health care. As the regulation of medicines becomes increasingly evidence and risk based, regulators have the challenge of dealing with the role of traditional use evidence in assessing the safety and efficacy of traditional medicines. Regulators must protect the consumer while also respecting the rights of consumers to have access as far as possible to medicines of their choice. Evidence for the safety and efficacy of traditionally used medicines is based largely on observation and experience over extended periods, sometimes gained over centuries of use. If Traditional Chinese Medicine (TCM) is used as an example, the evidence has evolved over millennia of use, and is still evolving, and the information is passed on through documentation such as in treatises and the education and training of practitioners (Figure 1).