SINO-EUROPE SYMPOSIUM ON TRADITIONAL CHINESE MEDICINE & HERBAL MEDICINE-MARKET OVERVIEW ®ULATION POLICY

Herbal Medicine Registration in Australia Diane Wilkinson

(Acting Director, Business Improvement and Support Section Complementary and OTC Medicines

Branch, Medicines Regulation Division, Health Products Regulation Group, Australia)

Founded in 1989, the agency is part of the Australian Federal Ministry of Health and our responsibilities are to ensure the health of Australian citizens, to improve their health and to provide timely and effective medicine regulation. The regulatory targets include, for example,prescription medicines, over-the-counter medicines,and a number of complementary health-care medicines,including traditional drugs, regulatory medical devices,biological agents, and blood products. In Australia, there is a special act on therapeutic products that was passed in 1989, along with supporting documents, including the regulations on therapeutic products, which were issued in 1990. Our medicine regulation is based on its risk level,and all Australian medicines must be registered on the ARTG catalogue before they can be exported or marketed.We check their quality safety and effectiveness before registering them on the ARTG catalogue, which is for high-risk medicines. For low-risk medicines, we call them catalogue medicines, which can be those that have not been reviewed by TGA, and they are also called simple catalogue medicines. There is another one that needs to be evaluated, and TGA only evaluates its effectiveness. 2 types of regulatory pathways based on risk categories are introduced, which are catalogue medicines, and registered drugs. Chinese medicine, for example, is low-risk and auxiliary drugs. Registered medicines are targeted at high-risk medicines, including over-the-counter drugs,and prescription medicines.

The most important point of regulation is to ensure that all pathways conform to GMP-compliant. In Australia, pre-marketing assessments are not required,but the GMP must be followed, so are the requirements of some permitted components or permitted indications.AUSTLA refers to an effective assessment prior to marketing and is subject to the GMP and component requirements. Requirements of the evidence should also be followed. And we should pay attention to the method of being registered on the catalogue and the compliance requirements after marketing.