关于中药新药研制技术要求的思考和建议  

Suggestions on technical requirements for traditional Chinese medicine new drug research and development

作　　者：唐健元 TANG Jian-yuan(Hospital of Chengdu University of Traditional Chinese Medicine,Chengdu 610072,China)

机构地区：[1]成都中医药大学附属医院,四川成都610072

出　　处：《中国中药杂志》2020年第16期4009-4016,共8页China Journal of Chinese Materia Medica

基　　金：四川省科技厅2020第一批科技攻关应急项目(2020YFS0012,2020YFS0013);成都市科技局2020市财政科技项目(第一批)(2020-YF05-00333-SN);成都中医药大学基金项目(XGZX2001,XGZX2002)。

摘　　要：该文回顾梳理自2007年版《药品注册管理办法》以来中药新药研制情况和相关技术要求。笔者就目前中药新药技术要求的痛点和技术审评中的一些典型案例进行了全面分析,并就中药审评理念和一些技术争议问题的解决提出了建设性意见,希望有助于监管机构和中药行业健康发展。The research and development progress and all relevant technical requirements about new Chinese medicines since the release of Provisions for Drug Registration(2007 Version)were reviewed and summarized in this paper.To promote the healthy deve-lopment of regulatory agencies and the traditional Chinese medicine industry,the author conducted a comprehensive analysis on the advantages and disadvantages of the current technical requirements for new Chinese medicines and some typical cases in technical review,and put forward some constructive suggestions on the philosophies of traditional Chinese medicine review and the resolution of some technical disputes.

关 键 词：中药 技术要求 药品评价 监管 

分 类 号：R288[医药卫生—中药学]