从药物特点和《药品注册管理办法》等层面对中药创新药的内涵进行了剖析,指出目前对中药创新药物的认识还是阶段性的,有待在发展中不断完善。根据当前中药新药的研究开发以及技术审评的状况,对研发方式进行了分析。结合对创新中药技术审评中所发现的问题,分析了目前中药创新药物研究开发过程中存在的七个方面的不足之处,根据中药自身的特点,提出了中药创新药物研究开发值得关注的问题。

Author analyzes new traditional Chinese medicine（TCM）, from an angle of medicinal properties and PRC Regulations of Drug Registration and Management. Author holds that the current understanding of new TCM is not clear,and nor comprehensive,though such understanding would go deeper along with the advance of new TCM R&D. Based on the technical evaluation of new TCM, and associated R&D status, new TCM R&D patterns are analyzed, and major prob- lems in seven areas sorted out. The paper also discusses the ideas and opinions deserving further attention.