中药注册与中药创新

Registration and Innovation in Traditional Chinese Medicine

中药产业的良性发展离不开科学的规划布局,中药科技创新的潜能挖掘也与注册监管的政策导向息息相关。2020年版《药品注册管理办法》将中药注册分为中药创新药、中药改良型新药、古代经典名方中药复方制剂、同名同方药4类。新分类对中药注册的监管思路作出重大调整,以临床价值为核心导向,带动物质基础创新。本文分析了创新型医药产业的特点以及美国食品药品监督管理局(FDA)药品注册分类的内涵,梳理了我国中药注册分类的演变情况,并在最新版《药品注册管理办法》基础上,综合我国国情和产业特点对中药注册分类提出了进一步思考和优化。

The sustainable development of the traditional Chinese medicine(TCM)industry relies on scientific planning and layout,while the potential for innovation in TCM technology is closely linked to the policy orientation of registration and supervision.The Provisions for Drug Registration(2020 edition)categorizes TCM registration into four types:innovative TCM,modified new drugs of TCM,compound preparations of TCM originated from classic recipes,and TCM with identical names and identical recipes.This new classification has significantly adjusted the regulatory approach to TCM registration,with a focus on clinical value and material basis innovation.This article analyzes the characteristics of the innovative pharmaceutical industry and the connotation of Foof and Drug Administration(FDA)drug registration classification,sorts out the evolution of China's TCM registration classification,and proposes further thinking and optimization for TCM registration based on the latest version of the Provisions for Drug Registration,taking into account national conditions and industrial characteristics.