《中国药典》2020年版基本概况和主要特点  

Overview of the Chinese Pharmacopoeia 2020 Edition

作　　者：兰奋[1] 洪小栩[1] 宋宗华[1] 张伟[1] LAN Fen;HONG Xiaoxu;SONG Zonghua;ZHANG Wei(Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国药品标准》2020年第3期185-188,共4页Drug Standards of China

摘　　要：2020年版《中国药典》是新中国成立以来的第十一版药典,将于2020年12月1日正式实施。本文对2020年版药典的整体情况进行了概要介绍。新版药典在品种收载、贯彻药品全生命周期管理理念、完善药品标准体系、加强药品安全性有效性控制、扩大成熟分析检测技术的应用、加强与国际药品标准协调等方面均取得了新的进展。新版药典的实施将对整体提升我国药品标准水平,提高药品质量,保证公众用药安全有效,促进医药产业高质量发展发挥重要作用。The Chinese Pharmacopoeia(ChP)2020 edition,which is the 11th edition since the first edition ChP was issued in 1953,will be put into implementation on December 1,2020.This papar gives a brief introduction on the development of the ChP 2020 edition.It is made great achievements for the ChP 2020 edition on increasing the number of monograph included,carrying out the idea of the drug life cycle management.Improving the national drug standards system,improving requirements on drug safety and efficacy,adopting more mature analytical techniques as well as strengthening the international drug standards harmonization.It will play important role for the new edition ChP implementation to improve the level of the National Drug Standards,assure the drug quality and guarantee the public drug-use safety and put forward the high quality development for the pharmaceutical industry in China.

关 键 词：中国药典 药品标准 质量控制 

分 类 号：R921.2[医药卫生—药学]