Impact of GMP on pharmaceutical industry in China based on indicator system evaluation  

GMP制度对中国医药产业影响评价指标体系研究（英文）

作　　者：陈哲[1] 戚梦露 叶国庆[2] 屈浩鹏 江滨[1,4] 

机构地区：[1]北京大学医学部 药学院 药事管理与临床药学系,北京100191 [2]国家食品药品监督管理总局办公厅,北京100053 [3]北京市食品药品监督管理局,北京100053 [4]北京大学 医药管理国际研究中心,北京100191

出　　处：《Journal of Chinese Pharmaceutical Sciences》2015年第3期185-191,共7页中国药学（英文版）

基　　金：National Social Science Fund(Grant No.13BGL141)

摘　　要：To evaluate the impact of GMP on Chinese pharmaceutical industry in a quantitative system, we referred to theories on policy evaluation and industrial organization, and conducted literature review, key person interview, multi-round Delphi and field investigation. We set up the principles to construct our indicator system, reviewed based on the policy objectives of the new GMP for drugs systematically, and analysed the influence path of the new GMP for pharmaceutical manufacturers. We proposed a three-dimensional ＂structure-conduct-performance＂ evaluation indicator system. Our evaluation indicator system is accepted by experts and relevant personnel, indicating the three-dimensional evaluation indicator system is feasible to evaluate the impact of the new GMP in Chinese pharmaceutical industry.为定量系统评估新版药品GMP制度对中国医药产业的影响,本研究在借鉴政策评估理论和产业组织理论等的基础上,应用文本研究、关键人物访谈、多次Delphi、实地调查等方法,制定了本次评估指标体系的构建原则,梳理了新版GMP制度的政策目标,分析了新版GMP制度对医药企业的影响路径,构建了"结构-行为-绩效"三维评价指标体系。本指标体系得到了相关专家和医药行业相关人员认可,表明本研究构建的"结构-行为-绩效"三维评价指标体系可以用于定量系统评估新版药品GMP制度对中国医药产业的影响。

关 键 词：GMP Pharmaceutical industry Indicator system Structure-conduct-performance 

分 类 号：R95[医药卫生—药学]