德国药品监管机构及职能概述  

Overview of Drug Regulatory Authorities and Functions in Germany

作　　者：杜婧 毕军 DU Jing;BI Jun(Center For Food and Drug Inspection of NMPA;License Review Center of Shenzhen Administration for Market Regulation)

机构地区：[1]国家药品监督管理局食品药品审核查验中心 [2]深圳市市场监督管理局许可审查中心

出　　处：《中国食品药品监管》2022年第1期40-49,共10页China Food & Drug Administration Magazine

摘　　要：德国属于欧盟成员国之一,在药品监管方面具有其特殊性及先进性。本文通过检索德国的法规文件和相关数据库,概述了德国药品监管的法规体系、组织机构和职责范围。我国与德国的行政区域划分方式和药品监管模式方面有许多相似点,2018年以来国家和地方药品监督管理部门进行了新一轮的机构改革和调整。本文期望通过对德国药品监管机构及职能的介绍,为我国药品监管科学研究和监管体系改革创新提供参考。Germany is one of the member states of the European Union and has certain particularity and advantages in drug supervision.This paper summarizes the regulatory system,organization and scope of responsibility of drug supervision in Germany by searching German regulatory documents and related databases.Since 2018,the Chinese national and provincial drug regulatory authorities have undergone a new round of institutional reform and adjustment.Because China and Germany have many similarities in terms of administrative division and drug supervision model,through introduction to the German drug regulatory authorities and functions,this paper hopes to provide insight for drug regulatory science research and the reform and innovation of the regulatory system in China.

关 键 词：德国 药品监管 法规 机构 职能 

分 类 号：R95[医药卫生—药学]