药品批准前生产现场检查的国内外比较研究与思考  

A multinational comparison of drug pre-approval production site inspection and recommendations

作　　者：王方敏[1] 朱娟[1] 周坛树[1] 高敏洁[1] 张豹子 吴浩[1] 陈承清 

机构地区：[1]上海市食品药品监督管理局认证审评中心,上海200020

出　　处：《中国新药杂志》2013年第5期509-512,共4页Chinese Journal of New Drugs

摘　　要：药品注册生产现场检查,是核实申报工艺的真实性和可行性非常有力的监管手段。然而,国家颁布的生产现场检查要点较为简要,在实施上尚无具体的指南或操作规程,在实际执行中存在着诸多困难,各地在实际执行中差异较大。本文对国内外的药品批准前生产现场检查的实施模式进行了比较研究,分析了国内目前检查工作存在的主要问题,结合国情,以规范检查的执行、提高监管的效率为目标,对国内生产现场检查的实施模式提出了建设性的意见。Production site inspection for drug registration is a strong administrative means to verify the integrity and achievability of the submitted manufacturing process. However, the requirements for production site inspection released by SFDA are essentials without detailed guidance or SOP for implementation, as well as there are many difficulties in practice, therefore, the operation varies from different regions. The research has compared domestic and foreign implementation approaches of pre-approval production site inspection from different countries, and analyzed the problems existed in domestic operations. Some constructive recommendations for domestic production site inspection approach are given in aim to standardize the operation and improve the efficacy of inspection.

关 键 词：药品注册 生产现场检查 批准前检查 监管策略 

分 类 号：R95[医药卫生—药学]