Key points of toxicology research in international registration of botanical drugs / 中国药理学与毒理学杂志

ABSTRACT

In recent years, traditional Chinese medicine (TCM) has made great progress in the process of internationalization,but the share of TCM is still insignificant in the international market.One of the reasons is that it is difficult to submit the documents in accordance with the drug registration reguirements of Europe and America. In this paper,the requirements of the international drug registration of botanical drugs are briefly introduced,involving the status of botanical drug international registration, the provisions of toxicological studies on botanical drug registration requirements in the United States and Europe, the difference in toxicological research between China and the United States, and the focus of the international registration of toxicological research.