摘要
目的:研究我国生物制品用辅料监管制度面临的风险,为完善我国的生物制品用辅料监管制度提供参考。方法:以我国的生物制品用辅料为研究对象,通过文献研究梳理我国生物制品用辅料的相关法律法规及国家标准,总结我国对生物制品用辅料的监管制度、现状以及潜在风险。结果与结论:我国现行按来源和安全风险进行分散式管理的生物制品用辅料监管模式存在潜在的安全风险,需对整体制度优化改良以改善现状。
Objective： To research China＇s regulatory system and current situation of biologics＇ excipients,providing reference for improving China＇s regulatory system of biologics＇ excipients. Methods： Focusing on China＇s pharmaceutical excipients used in biologics,we reviewed China＇s regulatory system,current status and lacks of biologics＇ excipients by sorting out China＇s laws,regulations and national standards. Results and Conclusion：Pharmaceutical excipients used in biologics are classified and managed according to the raw resources and safety issues with some potential risks,it is necessary to optimize the overall system for improving present situation.
作者
邹宜諠
陈云
邵蓉
周斌
ZOU Yi-xuan;CHEN Yun;SHAO Rong;ZHOU Bin(China State Institute of Pharmaceutical Industry,Shanghai 201203,China;China Pharmaceutical University,Nanjing 211198,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第17期2006-2010,共5页
Chinese Journal of New Drugs
关键词
生物制品
药用辅料
风险
管理
biologics
pharmaceutical excipients
risks
management
