Regulation and new drug application of botanical drugs in the world / 中国药理学与毒理学杂志

ABSTRACT

This review summarizes the developmental history of natural products and research status of botanical products in different oversea countries. This paper outlines the regulation for new drug application of botanical drugs from the USA, European Union, and Japan. It also uses the Vergen (the first botanical drug approved by US FDA) as an example to discuss how to meet regulatory require-ments for new drug applications.