药品研发以高投入、高风险著称。近年来,随着一系列新的药品注册法规的实施,药品的研发与评价较之以往有所不同。文中介绍近年来中药新药注册不批准的情况,对不批准原因进行分析,并对中药新药研究提出了一些思考和建议,以期为中药新药的研究与注册提供有益的参考。 Drug research and development to high investment, high risk known. In recent years, with the implementation of a series of new drug registration laws and regulations, the research and development and evaluation of medicines have become different from the past. In this paper, we introduce the non-approval of new drug registration in recent years, analyze the reasons of non-approval, and put forward some thoughts and suggestions on the research of new drug in Chinese medicine in order to provide useful reference for the research and registration of new drug of traditional Chinese medicine.