加强我国药品GLP管理的对策及建议  

Strategy and Suggestion on Strengthening Regulation of National Pharmaceuticals GLP

作　　者：杨茉[1] 孟庆贺[1] 邢花[1] 宋宏宇 

机构地区：[1]沈阳药科大学,沈阳110016 [2]国家沈阳新药安全评价研究中心

出　　处：《中国药事》2014年第4期365-367,共3页Chinese Pharmaceutical Affairs

摘　　要：目的为完善我国药品GLP管理提出对策及建议。方法通过比较国内外药品GLP管理要求,进而分析了我国药品GLP管理存在的问题,提出提升我国药品GLP管理水平的应对策略。结果与结论发现工作者认知水平存在差异,我国GLP与国际GLP法理存在差距等问题。采取加强政府规制,提高从业者责任意识,以及利用信息技术构建GLP平台的对策,以期对提高我国GLP管理水平给予一定指导和帮助。Objective To perfect the management of our national GLP, and render measures and advice. Methods Based on the comparison of medicine GLP management requirements at home and abroad, some existing problems at home were analyzed, and the coping strategies were put forward to promote Chinese GLP management. Results and Conclusion There exist differences in operating staff quality and idea of law for domestic and foreign GLP management. Strengthening government regulation, enhancing staff＇s sense of responsibility as well as establishing a GLP information platform are the advice put forward to promote Chinese GLP management.

关 键 词：药品GLP 管理 对策 建议 

分 类 号：R954[医药卫生—药学]