我国进口药品管理制度对药品检验的影响和启示  

Influence and Enlightenment of China′s Imported Drug Management System on Drug Inspection

作　　者：王颖 WANG Ying(Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring,Shanghai,China 200040)

机构地区：[1]上海市药品和医疗器械不良反应监测中心,上海200040

出　　处：《中国药业》2023年第21期1-4,共4页China Pharmaceuticals

摘　　要：目的 推进进口药品管理制度的改革创新,为药品高质量发展营造良性发展的制度环境。方法 通过文件及文献梳理等方式,了解我国进口药品的相关管理制度,总结相关管理制度对药品监督检验的影响,分析各地、各部门积累实践经验下取消进口药品逐批检查(以下简称批批检)的意义,并提出完善我国进口药品的监管建议。结果 随着进口药品贸易规模的持续扩大,以及药品治理改革和创新的总体思路和制度框架的确立,现行管理办法已不适应行业发展需求。进口药品的检验不合格率很低,取消批批检制度在物流、通关、检验、仓储等方面为企业和监管部门均带来了极大便利。结论 通过加快法律法规的修订进程,部署取消批批检品种的抽检工作,完善信息数据库系统建设,可提升临床用药的可及性。Objective To promote the reform and innovation of the management system for imported drugs,and to create a benign institutional environment for the high-quality development of drugs.Methods By reviewing documents and literature,the relevant management systems for imported drugs in China and their influence on drug supervision and inspection were summarized,the significance of canceling batch inspection of imported drugs based on the accumulated practical experience of various localities and departments was analyzed,and suggestions for improving the supervision of imported drugs in China were proposed.Results With the continuous expansion of the trade scale of imported drugs and the establishment of the overall ideas and institutional framework for drug governance reform and innovation,the current management methods were no longer suitable for the development needs of the industry.The inspection failure rate of imported drugs was very low,and the cancellation of the batch inspection system has brought great convenience to enterprises and regulatory authorities in logistics,customs clearance,inspection,storage,and other aspects.Conclusion The accessibility of clinical medication could be improved by speeding up the revision process of laws and regulations,deploying the sampling inspection of drugs for which batch inspection has been canceled,and improving the construction of the information database system.

关 键 词：进口药品 管理制度 药品检验 药品监管 

分 类 号：R95[医药卫生—药学]