从“三药三方”谈中药新药审评理念、研发思路及策略

Strategy and thinking of the development and review policies of traditional Chinese medicine(TCM)new drugs taking“three Chinese patent medicines and three TCM prescriptions”as examples

大批中医方药在新发传染病防治中发挥了积极作用,蕴含着巨大的研发潜能。然而近年来,中药新药研发持续低迷、获批难度大。本文结合药物审评趋势及新型冠状病毒肺炎中医“三药三方”研发实例,从中药新药审评理念与规则、研发思路与方法以及资源配置与利用角度,探讨了完善中药新药整体研发布局、明确人用经验证据评价标准、“证病结合”监管中药复方新药适应证、坚持中西医差异化竞争、多学科手段介入处方筛选、采用一体化研究设计、加大高质量临床研究投入、整合资源突破国际壁垒的一系列策略。

A large number of traditional Chinese medicine(TCM)prescriptions have played an active role in the prevention and treatment of emerging epidemic diseases,which contain huge potential of research and development(R&D).However,in recent years,few TCM new drugs have been approved for market and the industry is in a downturn.With examples of the recent drug review policies and the“three Chinese patent medicines and three TCM prescriptions”for Corona Virus Disease 2019(COVID-19),this article proposed a series of strategies from the perspectives of review and R&D of TCM new drugs as well as resource allocation.The strategies are improving the R&D layout of TCM new drugs,clarifying the evaluation criteria of human experience evidence,supervising the syndrome indications for TCM new drugs other than diseases,implementing differentiation competitive strategy,applying multi-disciplinary methods in prescription screening,applying integrated research design,increasing investment in high-quality clinical research,and integrating resources to break through international barriers.