摘要
对原国家食品药品监督管理总局发布的《中药经典名方复方制剂简化注册审批管理规定(征求意见稿)》、国家药品监督管理局发布的《中药古代经典名方中药复方制剂简化注册审批管理规定》和国家中医药管理局公布的《古代经典名方目录(第一批)》等一系列关于经典名方的政策法规进行分析,从经典名方目录遴选、制剂要求、知识产权保护和监管等方面,提出经典名方研究和管理的看法和建议。
China Food and Drug Administration and State Administration of Traditional Chinese Medicine of the People＇s Republic of China issued simplified registration approval management regulations and other policies and regulations in the Chinese medicine compound preparation of the classical representative famous prescription（ draft）. This paper analyzes,explains and put forward the views and opinions to the policies and regulations in preparation requirements, protection of Intellectual property and regulation.
作者
兰青山
肖苏萍
黄掌欣
袁春平
王继永
付春梅
LAN Qing-shan;XIAO Su-ping;HUANG Zhang-xin;YUAN Chun-ping;WANG Ji-yong;FU Chun-mei(China National of Traditional ＆ Herbal Medicine Co.,Ltd,Beijing 100195,China;China Traditional Chinese Medicine Holdings Co.,Ltd,Foshan 528303,China;Beijing University of Chinese Medicine,Beijing 100029,China)
出处
《中国现代中药》
CAS
2018年第7期780-784,共5页
Modern Chinese Medicine
基金
国家科技重大新药创制专项(2018ZX09721005-007)
关键词
经典名方
政策法规
制剂要求
知识产权保护
监管
Classical representative famous prescription
policies and regulations
preparation requirements
protection of ：intellectual property
regulation
