Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (11): 664-668.

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Management Research of EU Drug Standard and Reference Material

LIU Si-qi, GAO Jing, YANG Yue   

  1. College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2014-06-19 Revised:2018-07-18 Online:2014-11-08 Published:2016-03-02

Abstract: Objective To study the management pattern of drug standard and reference material in European Union, and put forward suggestions on developing scientific management system of drug standard in China. Methods Analyze management processes and advantages in European Union by consulting EDQM website, and compare them with current situation of China. Results The elaboration of European pharmacopoeia fully demonstrated its standardization, authority, timeliness and transparency, and all parties had specific responsibilities. Conclusion The management pattern and features are useful references for China to improve drug standard.

Key words: drug standard, reference material, management pattern

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