对药品生产企业的药品流通实施电子监管的现状与对策  

Current Situation and Countermeasures of the Implementation of Drug Electronic Supervision in Pharmaceutical Manufacturers

作　　者：杨迪雅[1] 叶桦[1] 

机构地区：[1]复旦大学药学院,上海201203

出　　处：《中国药事》2013年第9期909-912,共4页Chinese Pharmaceutical Affairs

摘　　要：目的切实加强对药品生产企业产品流通的电子监管。方法分析对药品生产企业产品流通实施电子监管中存在的问题,提出解决的建议。结果与结论应进一步论证药品全品种电子监管的豁免品种,尽快增补或修订《药品管理法》和《药品生产质量管理规范》(GMP)中有关药品电子监管的条款,加强电子监管人员的教育和培训,制定相关政策弥补生产企业的经济损失,提高药品电子监管平台的稳定性和安全性。Objective To explore strategies to strengthen electronic supervision in pharmaceutical manufacturers. Methods Existing obstacles to implementing the electronic supervision were analyzed, and suggestions were respectively given. Results and Conclusion It is necessary to further analyze the exemption drugs in electronic supervision system and revise drug administration law and electronic supervision parts of Good Manufacturing Practice （GMP） as soon as possible, strengthen education and training of manufacturer staff, make stability and security of the preferential policies to support manufacturers financially, and improve the whole supervision system.

关 键 词：药品电子监管 药品生产企业 流通 

分 类 号：R95[医药卫生—药学]