美欧日药品监管趋势对中国药品监管变革的启示

doi:10.5246/jcps.2014.05.045

中国药学(英文版) ›› 2014, Vol. 23 ›› Issue (5): 324-329.DOI: 10.5246/jcps.2014.05.045

美欧日药品监管趋势对中国药品监管变革的启示

郑晓元¹, 张士侠², 杨松¹, 李研嫣¹, 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. 国家食品药品监督管理总局, 北京 100053

收稿日期:2013-09-26 修回日期:2013-10-19 出版日期:2014-05-23 发布日期:2013-11-20
通讯作者: Tel.:13601100121; E-mail: binjiang@bjmu.edu.cn
基金资助:
National Social Science Fund (Grant No.13BGL141).

The impact of drug administration in USA, Europe and Japan on the reform plan in China

Xiaoyuan Zheng¹, Shixia Zhang², Song Yang¹, Yanyan Li¹, Bin Jiang^1*

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

Received:2013-09-26 Revised:2013-10-19 Online:2014-05-23 Published:2013-11-20
Contact: Tel.:13601100121; E-mail: binjiang@bjmu.edu.cn
Supported by:
National Social Science Fund (Grant No.13BGL141).

摘要/Abstract

摘要：

通过检索并分析国内外一手文献, 梳理了上个世纪九十年代以来, 美国、欧盟和日本这三个全球最大的医药经济体在药品监管实践中的最新进展和重大变革趋势, 结合国内药品监管实践, 探讨了中国药品监管变革的路径。作者认为, 在全球化时代, 国家食品药品监督管理总局应该实施全程化监管, 尤其是加强上市后监测, 通过提高监管科学以改善决策, 提供更好的服务以促进产业发展, 并加强国际交流合作, 使监管标准与发达国家保持一致, 从而促进药品安全。

关键词: 药品监督管理, 国际药品监管, 中国药品监管

Abstract:

It is critical to ensure the safety and efficacy of human drugs through drug administration. Drug administration has a long history in developed countries, such as USA, European Union and Japan, and has achieved great success. In this study, we summarized the important changes in the practice of drug administration in USA, European Union and Japan since 1990s. We also discussed how these changes and experience could be applied in the reform plan in drug administration in China Food and Drug Administration (CFDA). Our suggestions on future developmentofCFDA include improving post-market surveillance, advancing regulatory science, strengthening service-oriented regulation, and international cooperation.

Key words: Drug administration, International drug administration, China drug administration

中图分类号:

R954

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

郑晓元, 张士侠, 杨松, 李研嫣, 江滨. 美欧日药品监管趋势对中国药品监管变革的启示[J]. 中国药学(英文版), 2014, 23(5): 324-329.

Xiaoyuan Zheng, Shixia Zhang, Song Yang, Yanyan Li, Bin Jiang. The impact of drug administration in USA, Europe and Japan on the reform plan in China[J]. Journal of Chinese Pharmaceutical Sciences, 2014, 23(5): 324-329.

参考文献

[1] Quan, M.; Yang, S.; Li,Y.Y.; Hou, Z.X. Chin. J. Pharm. Sci. 2013, 6, 503–507.

[2] http://www.fda.gov/InternationalPrograms/FDABeyond OurBordersForeignOffices/default.htm

[3] http://www.fda.gov/AboutFDA/CentersOffices/Officeof GlobalRegulatoryOperationsandPolicy/default.htm

[4] http://www.fda.gov/downloads/AboutFDA/ReportsManuals Forms/Reports/UCM317835.pdf

[5] Liu, L.; Yang, Y. Chin. J. New Drugs. 2011, 20, 1941–1945.

[6] http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityand SupplyChainSecurity/default.htm

[7] http://www.fda.gov/ForIndustry/ImportProgram/ucm 172743.htm

[8] http://www.cersi.umd.edu/

[9] http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm324373.htm

[10] http://en.wikipedia.org/wiki/European_Medicines_Agency

[11] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000492.jsp&mid=WC0b01ac058033e8ad

[12] http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000538.jsp&mid=WC0b01ac058058cb19

[13] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000295.jsp&mid=WC0b01ac058007f4bb

[14] http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000504.jsp&mid= C0b01ac058050f347

[15] http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000060.jsp&mid=WC0b01ac0580024b94

[16] http://www.ema.europa.eu/docs/en_GB/document_library/ Brochure/2011/03/WC500104237.pdf

[17] http://www.pmda.go.jp/english/scienceboard/subcommittees. html

[18] Xi, X.Y.; Li, G.F. Chin. J. Pharma. 2010, 10, 587–591.

[19] Dong, J.P. Chin. Pharm. 2009, 25, 1928–1930.

[20] http://www.sda.gov.cn/WS01/CL0900/69672.html

[21] Sun, Y.M.S. Thesis, Study on drug examination and approval system of China--analysis from aspects of administrative laws, Soochow University, 2008.

美欧日药品监管趋势对中国药品监管变革的启示

The impact of drug administration in USA, Europe and Japan on the reform plan in China

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