摘要
药品上市前及上市后的各种变更可能对药品的安全性、有效性、质量可控性产生重大影响,药品变更管理也因此受到各国监管机构和法律体系的严格规定。我国药品变更管理的法律体系在2019年新修订《药品管理法》及其配套的部门规章与技术指南出台之后开始日趋完善。本文将对我国药品变更管理法律体系的基本框架、历史变迁与最新发展进行概括与梳理,并对进一步完善药品变更管理法律体系提出初步建议。
Drug changes may have major impact on the safety,effectiveness and quality controllability of drugs.Management of drug changes is subject to oversight by government agencies and legal systems around the world.The legal system for drug change management in China has been greatly improved since the promulgation of the newly-revised Drug Administration Law in 2019,its relevant provisions and technical guidelines.This article introduces the basic framework,historical and latest developments of the legal system for drug change management in China,and offers suggestions for further improvement.
作者
陈少羽
王文佳
戴安迪
杨语涵
CHEN Shao-yu;WANG Wen-jia;DAI An-di;YANG Yu-han(Arnold&Porter Shanghai Representative Office)
出处
《中国食品药品监管》
2021年第7期84-91,共8页
China Food & Drug Administration Magazine
关键词
药品变更
临床变更
药学变更
药品上市前变更
药品上市后变更
drug changes
clinical changes
pharmaceutical changes
pre-marketing changes
post-marketing changes
