我国药品非现场检查工作困境及对策研究  

A study on the dilemma and countermeasures of drug off-site inspection in China

作　　者：张婕颖 李军[1] 赵枫 范瑞雪 张苗苗 茅宁莹[1] ZHANG Jie-ying;LI Jun;ZHAO Feng;FAN Rui-xue;ZHANG Miao-miao;MAO Ning-ying(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)

机构地区：[1]中国药科大学国际医药商学院,南京211198

出　　处：《中国新药杂志》2025年第1期20-26,共7页Chinese Journal of New Drugs

基　　金：2023年中国药品监督管理研究会课题(2023-Y-Y-019);江苏省科技厅软科学项目(BR2022068);江苏省社科基金一般项目(22JZB002);江苏省高校哲学社会科学研究项目(2021SJA0075)。

摘　　要：药品非现场检查已经成为当前药品监管创新发展的重要趋势之一,在一定程度上能够对药品检查效能、效率和效果的完善发挥积极作用。本研究通过德尔菲法,访谈药品检查各个专业领域的资深检查人员和接受过药品非现场检查的企业管理人员,识别、分析药品非现场检查工作的困境,主要包括制度困境、技术困境和信任困境,并提出加快出台制度规范文件、明确适用范围、建设配套信息技术平台和设施设备、提升药品检查员队伍专业素质、建立数据保密机制等应对策略,有助于真正实现非现场检查技术的赋能,促进智慧监管科学体系现代化。Drug off-site inspection has become an important trend in the development of drug regulatory innovation.It plays a positive role in the improvement of drug inspection efficiency and effectiveness to a certain extent.The Delphi method was used in this study to interview senior inspectors from various professional fields of drug inspection,as well as enterprise managers who had undergone off-site drug inspections.The dilemmas in off-site drug inspection work,mainly including institutional dilemmas,technical dilemmas,and trust dilemmas,were identified and analyzed.Strategies are proposed to accelerate the introduction of institutional normative documents,clarify the scope of application,build supporting information technology platforms and facilities,improve the professional quality of drug inspectors,and establish data confidentiality mechanisms,which is of help to truly empower off-site inspection technology and promote the modernization of the smart regulatory scientific system.

关 键 词：非现场检查 药品 困境 监管科学体系 

分 类 号：R95[医药卫生—药学]