近年来,有几十种已完成全部临床前及临床试验的西药新药,因为安全性、有效性不符合要求而未能获得批准。这些问题也同样是中药新药研制中的关键。本文结合上述西药研制中出现的问题,对中药新药研发的安全性、有效性研究提出相关意见与建议,为中药新药研发提供思路与方法。 In recent years, dozens of new western medicine drugs that have completed all pre-clinical and clinical trials have not been approved because their safety and efficacy do not meet the requirements. These problems are also the key to the development of new drug of traditional Chinese medicine. Based on the above problems in the development of western medicine, this paper puts forward relevant opinions and suggestions on the safety and efficacy of new drug research and development, and provides ideas and methods for the research and development of new Chinese medicine.