A comparative study of regulations on botanicals registration in Australia and the European Union / 国际中医中药杂志

ABSTRACT

Australia and EU Member States have been the important components of global herbal medicine market. The legal use of Chinese Materia Medica in Australia and EU Member States is closely related to the internationalization of Chinese medicine, therefore it is of great significance to conduct a comparative study on their herbal medicine registration regulations. By summarizing the regulations issued by Therapeutic Goods Administration (TGA) and European Medicines Agency (EMA), and comparing related definitions and the regulations on quality management and medicinal product registration, we found that the method No.3 of L (A) 3 and the traditional-use registration are more conductive to bringing Chinese patent medicines to market in Australia and the EU Member States.