人用经验证据支持儿童中药新药注册及说明书变更的若干思考

通过系统梳理相关政策法规、指导原则和研究文献,结合笔者的中药研发实践,在中医药理论、人用经验、临床试验"三结合"中药注册审批证据体系模式下,重点思考了人用经验及其证据形成、人用经验证据支持儿童中药新药注册和说明书变更几方面问题,提出了一些个人认识,供儿童中药研发相关各方参考,以期充分利用人用经验证据,节约临床试验资源,加速儿童中药品种的研发进程。

Some thoughts on human experience to support registration and modification of specification for children's new drug application of traditional Chinese medicine

In this paper, through systematically reviewing relevant policies and regulations, guidelines and research literature, and combining with the author''s practice of the research and development of traditional Chinese medicine (TCM), we focus on human experience and its evidence formation, and human experience evidence to support the registration of registration and modification of specification for children''s new drug application of traditional Chinese medicine under the "triple combination" TCM registration and approval evidence system model of TCM theory, human experience and clinical trials. In this paper, we have put forward some personal views for the reference of all parties involved in the development of Chinese medicine for children, so as to make full use of human experience and evidence, save clinical trial resources, and accelerate the development of children''s Chinese medicine varieties.