中国药品监管制度变迁及完善研究

doi:10.5246/jcps.2015.12.105

中国药学(英文版) ›› 2015, Vol. 24 ›› Issue (12): 821-825.DOI: 10.5246/jcps.2015.12.105

中国药品监管制度变迁及完善研究

陈路佳¹, 刘国臻², 黄果³, 杨东升^4*, 江滨^1*

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. 北京大学医学部医学人文学院, 北京 100191
3. 国家食品药品监督管理总局, 北京 100053
4. 药品研制和开发行业委员会, 北京 100004

收稿日期:2015-06-24 修回日期:2015-07-14 出版日期:2015-12-22 发布日期:2015-09-10
通讯作者: Tel.: 13601100121, E-mail: binjiang@bjmu.edu.cn
基金资助:
National Social Science Fund (Grant No. 13BGL141).

Institutional changes of China's drug regulation and improvement solutions

Lujia Chen¹, Guozhen Liu², Guo Huang³, Dongsheng Yang^4*, Bin Jiang^1*

1. Department of Administrative and Clinical Pharmacy, School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing 100191, China
2. Institute for Medical Humanities, Peking University Health Science Center, Beijing 100191, China
3. China Food and Drug Administration, Beijing 100053, China
4. R&D-based Pharmaceutical Association Committee, Beijing 100004, China

Received:2015-06-24 Revised:2015-07-14 Online:2015-12-22 Published:2015-09-10
Contact: Tel.: 13601100121, E-mail: binjiang@bjmu.edu.cn
Supported by:
National Social Science Fund (Grant No. 13BGL141).

摘要/Abstract

摘要：

药品是事关公众健康和社会安全的特殊商品, 各国均通过建立监管制度确保药品安全。本文从制度变迁的视角, 分析解放以来我国药品监管制度变迁过程, 归纳出有关问题, 并提出明确药品监管的职能定位、增加中央层面的药监投入、合理划分纵向药品监管职能、完善监管部门监督机制等建议。

关键词: 药品监管, 制度变迁, 纵向分权

Abstract:

Drug regulation is the most important policy to ensure drug safety. In this article, we analyzed institutional changes and problems in China’s drug regulation. In addition, suggestions were provided to enhance the capacity of drug regulation, including a clearer functional positioning for drug regulation, increased resource inputs in drug regulation at central level, a more rational allocation of vertical drug regulatory functions, and an improved supervision mechanism for regulatory departments.

Key words: Drug regulation, Institutional change, Vertical allocation

中图分类号:

R951

Supporting:

陈路佳, 刘国臻, 黄果, 杨东升, 江滨. 中国药品监管制度变迁及完善研究[J]. 中国药学(英文版), 2015, 24(12): 821-825.

Lujia Chen, Guozhen Liu, Guo Huang, Dongsheng Yang, Bin Jiang. Institutional changes of China's drug regulation and improvement solutions[J]. Journal of Chinese Pharmaceutical Sciences, 2015, 24(12): 821-825.

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中国药品监管制度变迁及完善研究

Institutional changes of China's drug regulation and improvement solutions

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