GMP制度对中国医药产业影响评价指标体系研究

doi:10.5246/jcps.2015.03.023

中国药学(英文版) ›› 2015, Vol. 24 ›› Issue (3): 185-191.DOI: 10.5246/jcps.2015.03.023

GMP制度对中国医药产业影响评价指标体系研究

陈哲¹, 戚梦露¹, 叶国庆², 屈浩鹏³, 江滨^1,4*

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

收稿日期:2014-05-10 修回日期:2014-06-02 出版日期:2015-03-29 发布日期:2015-01-10
通讯作者: Tel.: 86-10-82801701-233
基金资助:
National Social Science Fund (Grant No. 13BGL141).

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

Zhe Chen¹, Menglu Qi¹, Guoqing Ye², Haopeng Qu³, Bin Jiang^1,4*

1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
2. China Food and Drug Administration, Beijing 100053, China
3. Beijing Food and Drug Administration, Beijing 100053, China
4. International Research Center for Medicinal Administration, Peking University, Beijing 100191, China

Received:2014-05-10 Revised:2014-06-02 Online:2015-03-29 Published:2015-01-10
Contact: Tel.: 86-10-82801701-233
Supported by:
National Social Science Fund (Grant No. 13BGL141).

摘要/Abstract

摘要：

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, 制药产业, 指标体系, 结构-行为-绩效

Abstract:

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, multiround 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 “structureconductperformance” 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.

Key words: GMP, Pharmaceutical industry, Indicator system, Structureconductperformance

中图分类号:

R956

Supporting:

陈哲, 戚梦露, 叶国庆, 屈浩鹏, 江滨. GMP制度对中国医药产业影响评价指标体系研究[J]. 中国药学(英文版), 2015, 24(3): 185-191.

Zhe Chen, Menglu Qi, Guoqing Ye, Haopeng Qu, Bin Jiang. Impact of GMP on pharmaceutical industry in China based on indicator system evaluation[J]. Journal of Chinese Pharmaceutical Sciences, 2015, 24(3): 185-191.

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GMP制度对中国医药产业影响评价指标体系研究

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

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