关键词: 药品标准, 标准物质, 管理模式

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.