摘要
为加快药品审评审批速度,国家药品监督管理局颁布一系列鼓励药品创新的政策,申请临床试验实行60日默示许可、建立沟通交流机制等制度。通过分析调整后的中药新药审评思路,充分认识药学阶段性研究的必要性,对中药注册申报不同阶段药学研究的侧重点从药材来源、工艺设计、质量标准建立等方面进行阐述,从而加快中药审评审批进程,为中药新药注册申报提供参考。
A series of policies to encourage innovative drug were issued and implemented in opinions of speeding up new drug review and approval by National Medical Products Administration,including application for drug clinical trials on 60 days of implied permission and the communication mechanism.In this article,we analyzed the adjustment of new drug review,and explained the necessity and difference in pharmaceutical research and development of Chinese materia medica(CMM),and illuminated the main problems and emphases in CMM pharmaceutical research in aspects of source of medicinal materials,production process,quality research and standards,expecting to provide reference for speeding up new drug review and benefit drug applicants.
作者
赵巍
马秀璟
屠鹏飞
ZHAO Wei;MA Xiu-jing;TU Peng-fei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China)
出处
《中草药》
CAS
CSCD
北大核心
2019年第23期5872-5875,共4页
Chinese Traditional and Herbal Drugs
关键词
中药新药
中药注册申报
药学阶段性研究
药材来源
工艺设计
质量标准
new drugs of Chinese materia medica
registration application of Chinese materia medica
pharmaceutical stage research
source of medicinal materials
process design
quality standard
作者简介
赵巍(1982—),女,副主任药师,主要从事药品技术审评工作,Tel:(010)85243480,E-mail:zhaow@cde.org.cn;通信作者:马秀環(1967—),女,主任药师,高级审评员,主要从事药品技术审评工作,Tel:(010)85242906,E-mail:maxj@cde.org.cn;通信作者:屠鹏飞(1963—),男,教授,博士生导师,主要从事中药活性成分及新药研究,Tel:(010)82802750,E-mail:pengfeitu@163.com。
