经典名方研发的现存问题及相关考虑

Current issues and related considerations in development of classical famous prescription

经典名方的研发受到国家战略支持,是中药产业发展的新机遇,是传承中药弘扬经典的新举措。当前,虽然对经典名方实行简化注册审批政策,但业界仍对经典名方的研发存在疑问。梳理出业界和审评审批部门现阶段共同面临的6个共性问题,并对可能存在的"涨料"问题进行分析。提倡发扬跨界合作精神,妥善解决现存的共性问题,加快古代经典名方中药复方制剂的上市进程。

The research and development of the classical famous prescription is supported by the national strategy,a new opportunity for the development of the traditional Chinese medicine(TCM)industry,and a new measure to carry out the classics of TCM.At present,although the abbreviated registration approval policy has been implemented for the classical famous prescription,the industry still has doubts about the development of the classical famous prescription.This paper sorts out the six common issues faced by the industry and the review and approval departments at this stage,and analyzes the possible"increasing extract"problem.Promote the spirit of cross-border cooperation,properly solve existing common issues,and speed up the listing process of ancient classic TCM compound preparations.