由肝素钠事件分析药品监管全球化趋势

中国药物警戒 ›› 2016, Vol. 13 ›› Issue (1): 42-46.

• 安全性评价与合理用药 • 上一篇下一篇

由肝素钠事件分析药品监管全球化趋势

田德龙¹黄志禄²

1.沈阳药科大学工商管理学院 ,辽宁沈阳 110016;
2.国家食品药品监督管理总局执业药师资格认证中心 ,北京 100098

收稿日期:2015-11-17 修回日期:2016-02-25 出版日期:2016-01-08 发布日期:2016-02-25
通讯作者: 黄志禄,男,主任药师,药事管理。
作者简介:田德龙, 男, 在读硕士, 药事管理。

Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event

TIAN De-long¹, HUANG Zhi-lu²

1.School of Business Administration ,Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China;
2.Certification Center for Licensed Pharmacist of CFDA, Beijing 100098, China

Received:2015-11-17 Revised:2016-02-25 Online:2016-01-08 Published:2016-02-25

摘要/Abstract

摘要： 目的为我国应对药品监管全球化挑战提供参考。方法通过剖析肝素钠事件中美国 FDA、涉事企业及相关各方应对过程 ,分析事件原因调查、检验、沟通、善后措施以及深层次供应链风险。结果药品监管全球化实质是原辅料、中间产品、制剂供应链的全球化。结论我国应借鉴美国药品全球化监管经验 ,顺应监管全球化趋势 ,采取积极应对措施以确保药品供应链安全。

关键词: 肝素钠事件, 药品监管全球化, 供应链

Abstract: Objective To provide some suggestions to cope with the challenges of drug regulatory globalization. Methods The investigation to the reason of event inspection, communication, rehabilitation and the deep risk of supply chain were analyzed through reviewing measures that FDA and relevant parties had given to heparin sodium event. Results Drug regulatory globalization is essentially the globalization of raw materials, intermediate products and preparations supply chain. Conclusion FDA’s global drug regulation has provided referential experience to China, and China should comply with the trend of regulatory globalization and take active countermeasures to ensure the safety of the drug supply chain.

Key words: heparin sodium event, drug regulatory globalization , supply chain

中图分类号:

R951

田德龙黄志禄. 由肝素钠事件分析药品监管全球化趋势[J]. 中国药物警戒, 2016, 13(1): 42-46.

TIAN De-long, HUANG Zhi-lu. Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event [J]. Chinese Journal of Pharmacovigilance, 2016, 13(1): 42-46.

参考文献

[1] Baxter U S. Safety Information: Heparin Sodium Injection -Background Information[EB/OL].(2008-04-29) [2014-10- 24].http://www.baxter.com/information/safety_information/heparin_background_information.html.
[2] FDA. Information on adverse event report and heparin [EB/OL].(2009-06-18) [2014-10-24].http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm112669.htm.
[3] Testimony of Robert L. Parkinson Chief Executive Officer, Baxter International Before Subcommittee on Oversight and Investigations Committee on Energy and Commerce U.S. House of Representatives April [EB/OL].(2008-04-29)[2014-11-01].http://www.baxter.com/downloads/information/safety_information/heparin/RLP_opening_comments.pdf.
[4] FDA. Warning Letter: Changzhou SPL Company ,Ltd.[EB/OL].(2008-0 4-21) [2014-11-01].http://www.fda.gov/ Warning Letter sand Notice of Violation Letters to Pharmaceutical Companies/UCM054109.Pdf.
[5] 韩亮, Nicholas, Buhay, 等. 美国FDA 药品生产质量监管体系[J].中国新药杂志, 2012, 21(18): 2128-2136.
[6] Blossom D B, Kallen A J, Patel P R, et al Outbreak of Adverse Reactions Associated with Contaminated Heparin[J]. N Engl J Med,2008,359(25): 2674-2684.
[7] Guerrini M, Beccati D, Shriver Z, et al.Over sulfated chondroitin sulfate is a contaminant in heparin associated with adverse clinical events [J].Nature Biotechnology,2008,26:669-675.
[8] 刘璐, 杨悦. 透过肝素钠事件看美国FDA 对质量缺陷药品的风险管理[J]. 中国新药杂志, 2011, 20(20): 1941-1945.
[9] FDA. Advancing Health Through Public Standards-- USP & FDA’s Response to Heparin Crisis: A Timeline of Events [EB/OL] .(2014-03-26) [2015-02-01].http://www.usp.org/sites/default/files/usp_pdf/EN/valueOfStandards/heparinTimeline.pdf.
[10] FDA. Office of Global Regulatory Operations and Policy[EB/OL] .(2011-09-11)[2015-02-01].http://www.fda.gov/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/default.htm.
[11] FDA. FDA Globalization[EB/OL]. (2015-07-13)[2015-10-05].http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOf fices/default.htm.
[12] FDA. Protecting Patients from Counterfeit and Other Substandard Drugs/Supply Chain Threats [EB/OL].(2012-12-04)[2015-03-05].http://www.fda.gov/downloads/forhealthprofessionals/ucm330640.pdf.
[13] FDA. Over view of Office of Pharmaceutical Quality (OPQ) [EB/OL].(2015-03-05) [2015-04-25].http://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm445608.pdf.
[14] FDA. PREDICT [EB/OL]. (2010-02-04) [2015-03-05].http://www.fdagov/newsevents/publichealthfocus/ucm199940.htm.
[15] FDA. Drug Supply Chain Security Act (DSCSA) [EB/OL]. (2013-11-27)[2015-03-10].http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm.
[16] Xiaoyuan Zheng, Shixia Zhang, Song Yang, et al. 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.

由肝素钠事件分析药品监管全球化趋势

Reflection on Drug Regulatory Globalization Trend from the Heparin Sodium Event

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