2025年版《中国药典》制修订情况概述  

Brief introduction on the development of Chinese Pharmacopoeia 2025 Edition

作　　者：洪小栩[1] 宋宗华[1] 马双成 兰奋[1] 舒融 HONG Xiaoxu;SONG Zonghua;MA Shuangcheng;LAN Fen;SHU Rong(Chinese Pharmacopoeia Commission,State Key Laboratory of Drug Regulatory Science,Beijing 100061,China)

机构地区：[1]国家药典委员会,药品监管科学全国重点实验室,北京100061

出　　处：《中国药品标准》2025年第1期1-10,共10页Drug Standards of China

基　　金：国家药品标准提高课题。

摘　　要：2025年版《中国药典》将于2025年3月颁布。《中国药典》是药品生产、检验、使用、监管的基本遵循。新版药典在品种收载、标准体系完善、药品质控新技术、新方法、新工具标准转化及应用、药品安全性有效性控制以及国际标准协调等方面有了很大的提升,对提高药品质量,保障公众用药安全,强化药品监管技术支撑、促进我国医药产业高质量发展将发挥重要作用。本文就2025年版《中国药典》制修订总体情况进行介绍,旨在帮助业界了解新版药典的主要变化,为新版药典的实施做好准备。The Pharmacopoeia of the People′s Republic of China 2025 edition is to be issued in March 2025.Chinese Pharmacopoeia is the basic requirements on the drug manufacture,drug testing,drug use and drug administration.The new edition Chinese Pharmacopoeia will be dramatically improved on the pharmacopoeia monographs included,establishing the standards system,standards conversion and application of drug quality control for the new technology,new method&new tool,drug control on the safety and effectiveness as well as the drug standard international harmonization.It will take important role on improving the drug quality,ensuring the safety of drugs for public use,strengthen technical support for drug administration,promoting the high-quality development of China′s medical and pharmaceutical industry.This paper introduces the development and revision of the Chinese Pharmacopoeia 2025 Edition,aim at helping the industries well understanding and implantation the new edition Chinese Pharmacopoeia.

关 键 词：2025年版《中国药典》 药品标准 质量控制 

分 类 号：R921.2[医药卫生—药学]