中药新药研发面临的问题及思考

Problems and thoughts on research and development of new traditional Chinese medicine

针对目前中药新药研发过程临床试验中经常发现的问题进行归类汇总与分析,供业内同行借鉴和参考,避免后续会出现类似相关问题,以进一步提升企业的申报能力以及提高国家药品监督管理局审评中心的审批效率。笔者主要从药物临床试验数据管理、质量控制、技术评价等多个维度进行详细分析,提出药物临床试验实际操作中需要关注的问题,最终实现通过真实、可靠、规范、可溯源的药物临床试验挖掘安全、有效、质量可控的药物。

For the reference of peers in the industry,summarize and analyze the problems frequently found in clinical trials during the research and development of new traditional Chinese medicine,to avoid similar related problems in the future,and finally to further improve the application ability of enterprises and improve the approval efficiency of the Centre for Drug Evaluation,National Medical Products Administration.The authors mainly analyze the data management,quality control,technical evaluation and other dimensions of drug clinical trials in detail,and puts forward the problems that need to be paid attention to in the actual operation of drug clinical trials.The ultimate purpose is to look forward to mining safe,effective,and quality-controlled drugs through real,reliable,standardized,and traceable drug clinical trials.