本文阐述作者在审评中药新药工作中的体会。认为在新药审评中,必须“依法审评”,以药政法规为原则,重视中医特色,同时,又要从中药新药研制的现状出发,应有一定的灵活性,在学术上要兼容并蓄,以促进中药新药研制的发展。 This article describes the author’s experience in reviewing new Chinese medicines. It is considered that in the review of new drugs, it is necessary to “review according to law”, to adopt the principles of drug and government regulations, and to pay attention to the characteristics of traditional Chinese medicine. At the same time, starting from the current status of research and development of new traditional Chinese medicines, there should be a certain degree of flexibility and be academically inclusive. In order to promote the development of new drugs in the development of traditional Chinese medicine.