食药监机构改革进程中的监管模式对比研究  

Comparative Study on the Regulatory Model of Food and Drug Administration in Institutional Reform

作　　者：王广平 魏美亮 夏萍萍 郝晓霞 李瑾 江滨[3] 张欣涛[4] Wang Guangping Wei Meiliang Xia Pingping Hao Xiaoxia Li Jin Jiang Bin Zhang Xintao(Shanghai Institute for Food and Drug Safety, Shanghai 200233, China Food and Drug Administration ofBeijing Haidian District, Beijing 100097, China School of Pharmaceutical Sciences, Peking University, Beijing 100191, China National Institutes of Food and Drug Control, Beijing 100050, China)

机构地区：[1]上海市食品药品安全研究中心,上海200233 [2]北京市海淀区食品药品监督管理局,北京100097 [3]北京大学药学院,北京100191 [4]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2016年第12期1215-1221,共7页Chinese Pharmaceutical Affairs

基　　金：国家社会科学基金资助项目-我国药品监管模式优化研究(编号13BGL141)

摘　　要：2013年,我国食品药品监管机构进行了机构改革和职能转变,取得显著成效。各省市的药品监管机构多种改革模式也凸显了食品药品工业专业化与综合监管执法、健康产业融合与市场综合监管之间的矛盾,影响到基层监管资源配置和能效发挥。本文基于食药监机构改革制度背景,对比分析了4种监管亚类型与国外监管模式,指出了当前食品药品监管模式绩效发挥的相关问题,并提出应对思路,包括维持组织机构稳定性,重新配置基层资源,重视中央地方职责同构,制定非正式制度转化规则等。China Food and Drug Administration（CFDA） began the regulatory reform and functional transformation in 2013. The fact that reform models are various in different provinces caused several prominent conflicts, such as the conflict between industry specialization and comprehensive regulatory enforcement, and the conflicts between health industry integrating and comprehensive market regulation, which negatively impact the resource allocating and of primary regulation. Based on the institutional background of the regulatory reform of CFDA, and comparative analysis of Chinese sub-types and foreign regulatory model, the effective methods of regulatory performance were proposed, such as the organization structural stability, primary regulatory resource reallocation, isomorphic responsibility between central and district government, and informal system converting rules.

关 键 词：机构改革 食品药品 监管模式 职责同构 基层监管 

分 类 号：R95[医药卫生—药学]