新形势下中药新药研发的思路与策略  

Ideas and strategies of new traditional Chinese medicine research and development under new situation

作　　者：张铁军[1,2,3] 刘昌孝 ZHANG Tie-jun;LIU Chang-xiao(Tianjin Institute of Pharmaceutical Research,Tianjin 300301,China;State Key Laboratory of Drug Delivery and Pharmacokinetics,Tianjin 300301,China;Tianjin Key Laboratory of Quality Marker of Traditional Chinese Medicine,Tianjin 300301,China)

机构地区：[1]天津药物研究院,天津300301 [2]释药技术与药物代谢国家重点实验室,天津300301 [3]天津市中药质量标志物重点实验,天津300301

出　　处：《中草药》2021年第1期1-8,共8页Chinese Traditional and Herbal Drugs

基　　金：国家重大新药创制专项(2018ZX09721004-006);国家重点研发计划资助项目(2019YFC1711201)。

摘　　要：中药新药研发中的中药创新研发是中药产业发展和科技进步的源泉,是关乎国计民生、解决临床重大疾病预防与治疗重大问题的关键途径。自1985年我国实行新药审评办法以来,中药新药研发通过多年的努力,取得了显著的进展。2020年3月30日,国家市场监督管理总局公布新的《药品注册管理办法》,同年10月,国家药品监督管理局发布了《中药注册分类及申报资料要求》,对中药新药研发提出了新的要求,也展示了新的发展机遇。基于中药新药的临床需求和市场环境以及新的中药注册要求,针对中药创新研发及成果转化过程中存在的关键瓶颈问题,提出新形势下中药新药研发的总体思路、研发策略和技术路径,以期为新形势下的中药新药研发提供参考。The research and development(R&D)of innovation of new traditional Chinese medicine(TCM)are the source of Chinese medicines industry development and scientific and technological progress,which are also the key approaches to the national economy and people’s livelihood and the prevention and treatment of major clinical diseases in clinic.Since the new drug evaluation method was implemented in 1985,the remarkable progress of research and development of new traditional Chinese medicine has been made through many years of efforts.On March 30,2020,the State Administration for Market Regulation published the new Provisions for Drug Registration,and the Nation Medical Product Administration issued the Registration Classification and Declaration Requirements for Traditional Chinese Medicine in October,2020,which put forward new requirements for the R&D of new TCM and also demonstrated new development opportunities.Based on the clinical demand,market environment and new registration requirements of new TCM,aiming at the key bottleneck problems in the process of innovative R&D and achievement transformation of TCM,the overall idea,R&D strategy and technical path of new TCM under the new situation were put forward in order to provide reference for the R&D of new TCM.

关 键 词：中药新药 总体思路 策略 技术路径 质量标志物 

分 类 号：R28[医药卫生—中药学]