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. 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. 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

PDF (PC)

433

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: