亚洲社会药学
亚洲社会药学

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›› 2014, Vol. 9 ›› Issue (4): 166-170.doi:

• 论文 • 上一篇    下一篇

Pharmacovigilance System for Pharmaceutical Enterprises in EU:Regulation and Its Enlightenment

ZHANG Hao, LIU Si-qi, WU Zhi-ang   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2014-12-20 发布日期:2014-12-20

Pharmacovigilance System for Pharmaceutical Enterprises in EU:Regulation and Its Enlightenment

ZHANG Hao, LIU Si-qi, WU Zhi-ang   

  1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
  • Received:1900-01-01 Revised:1900-01-01 Online:2014-12-20 Published:2014-12-20
  • Contact: WU Zhi-ang

摘要： Objective To provide references for China’s pharmaceutical enterprises by studying the pharmacovigilance system in EU, which
is one of the most advanced and comprehensive monitoring system. Methods The contents and methods of pharmacovigilance
system for pharmaceutical enterprises in EU were introduced based on the framework of social regulation. Results and Conclusion
The social regulations of pharmacovigilance system include the set up of qualification system, information disclosure system and
certification system. Establishing a scientific and reasonable pharmacovigilance system is an important measure for the government
to control the drug risks and it is also an effective way to ensure drug safety after listing.

关键词: manufacturing enterprise, pharmacovigilance system, social regulation

Abstract: Objective To provide references for China’s pharmaceutical enterprises by studying the pharmacovigilance system in EU, which
is one of the most advanced and comprehensive monitoring system. Methods The contents and methods of pharmacovigilance
system for pharmaceutical enterprises in EU were introduced based on the framework of social regulation. Results and Conclusion
The social regulations of pharmacovigilance system include the set up of qualification system, information disclosure system and
certification system. Establishing a scientific and reasonable pharmacovigilance system is an important measure for the government
to control the drug risks and it is also an effective way to ensure drug safety after listing.

Key words: manufacturing enterprise, pharmacovigilance system, social regulation

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