新冠肺炎疫情下关于加快中药注册制度改革的思考

Thoughts on Speeding up the Reform of Registration System of Traditional Chinese Medicine under the COVID-19 Epidemic

在新冠肺炎疫情防控中,中医药参与率和有效率达90%以上,发挥了独特优势。中药注册管理贯穿中药研发、审批、生产、上市和销售等各环节,对中药发展具有重要的指导意义。首先分析了治疗新冠肺炎的中成药、处方及其组方,梳理了我国中药注册制度的发展历史。接着从中药新药申报与审批情况、新药治疗领域、剂型和现行中药注册制度四个角度,分析了我国中药注册的现状和问题,并提出相应建议,即探索建立以人用经验和临床疗效为标准的中药安全性和有效性的评价体系,简化注册审批流程,对已上市药进行技术创新,优化和规范医院经典名方中药制剂,真正让好方子用到实处。

Traditional Chinese medicine(TCM)played an important role in the prevention and control of novel coronavirus pneumonia(NCP).Registration management of traditional Chinese medicine runs through the research and development,approval,production,marketing and sales of traditional Chinese medicine,which has important guiding significance for the development of traditional Chinese medicine.The paper analyzes the Chinese patent medicines,prescriptions and formulations for the treatment of COVID-19,and sorts out the development history of Chinese traditional medicine registration system.Then,the paper analyzes the status and problems of the registration of traditional Chinese medicine from four perspectives,including the application and approval of new drugs,the treatment field of new drugs,the dosage forms and the current registration system of traditional Chinese medicine,and puts forward corresponding suggestions.That is,people will explore the establishment of an evaluation system for the safety and efficacy of traditional Chinese medicine based on human experience and clinical efficacy,simplify the registration and approval process,carry out technical innovation for the listed drugs,optimize and standardize the famous traditional Chinese medicine prescriptions in hospitals,and truly make good prescriptions available.