中药新药研发与注册过程中的沟通交流

Communication in process of R&D and registration of new drugs of traditional Chinese medicine

近年来,国家药品监督管理局建立了在药品研制和注册过程中的沟通交流机制。该文总结了近年来有关建立药品审评沟通交流制度的改革政策以及具体法规、规章内容,对沟通交流的渠道、流程、方式、类型等进行梳理,并基于临床实践总结、申请临床试验、临床试验期间、上市申请及上市后的再研究等全过程对中药新药沟通交流的现状进行总结,针对目前存在的不沟通、无效沟通、低效沟通、反复沟通等问题进行分析,并给出开展有效沟通交流的考虑和建议,以期为申请人更好地开展沟通交流工作提供参考。

In recent years,the National Medical Products Administration has established a communication system for the process of drug R&D and registration.In this paper,the reform policies on establishing the communication system for drug evaluation in recent years were summarized,and the channels,processes,methods and types of communication were also collected.In addition,the communication status of new drugs of traditional Chinese medicine(TCM)was summarized according to the whole process of R&D,including summary of clinical practice,Investigational New Drug Applications,period of clinical trials,New Drug Applications,and post-marketing researches.Meanwhile,the current problems such as ineffective,inefficient,repeated or even no communication were analyzed,and relevant suggestions were proposed accordingly in order to provide reference for better communication on R&D and registration of new drugs of TCM.