摘要
目的通过对欧盟药品标准及标准物质管理模式进行研究,以期对我国建立科学的药品标准管理体系提出借鉴。方法查阅EDQM网站,分析欧盟相关管理流程,与我国当前现状进行对比研究。结果欧洲药典制定过程充分展现其规范性、先进性与权威性、时效性与公开透明性,同时标准与标准物质制修订过程各方职责明确。结论我国可以借鉴欧盟药品标准管理中的相关模式与特点,以提高药品标准。
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.
出处
《中国药物警戒》
2014年第11期664-668,671,共6页
Chinese Journal of Pharmacovigilance
关键词
药品标准
标准物质
管理模式
drug standard
reference material
management pattern
