药品监管电子证照应用发展研究与探析  

Research and Analysis on the Application and Development of Electronic Licenses for Drug Regulation

作　　者：田雅轩 陆颖 TIAN Yaxuan;LU Ying(Information Center of NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局信息中心,北京100076

出　　处：《中国医药导刊》2025年第2期123-127,共5页Chinese Journal of Medicinal Guide

摘　　要：随着“互联网+政务服务”深入推进,各地区各部门依托全国一体化在线政务服务平台,积极推进电子证照应用。本研究基于国家药品监督管理局开展涉企证照电子化工作研究实践,认为在药物临床试验、药品上市许可、药品注册、药品补充申请、中药品种保护、进口药材、化学原料药证书及药物非临床研究质量管理规范认证证书相关药品监管电子证照制发、标准制定等方面已取得了一定成效,同时,提出目前药品监管电子证照推进工作中存在的问题,并针对当前药品监管电子证照应用中存在的数据标准执行未彻底、应用范围有限、安全性亟待提高、管理机制有待完善等重要堵点,提出药品监管电子证照未来应用推广举措,基于全国一体化在线政务服务平台探索优化药品监管电子证照应用标准,拓展药品监管电子证照应用场景,构建高效、优质、便捷、安全、可信的药品监管电子证照服务体系,实现药品监管电子证照跨地区、跨部门共享和全国范围内互信互认,为进一步发挥电子证照在政务服务中的作用,提升药品智慧监管,促进高水平社会共治提供参考。With the deepening of"Internet plus government service",each regions and departments are actively promoting the applica-tion of electronic licemses based on the national integrated online government service platform.Based on the practice of the National Medical Products Administration(NMPA)to carry out the work of electronic business licenses,this study conducted research on the elec-tronization of enterprise related licenses.The development and standardization of electronic licenses for drug supervision related to drug clinical trials,drug marketing authorization,drug registration,drug supplement applications,protection of traditional Chinese medicine varieties,imported medicinal materials,chemical bulk drug certificates,and GLP certification have made some achievements.At the same time,there still exists some problems in the promotion of electronic licenses for drug regulation.This study proposed measures for the future application and promotion of electronic licenses for drug regulation in response to important obstacles in the current application of electronic licenses for drug regulation,such as incomplete implementation of data standards,limited application scope,need to improve safety,and need to improve management mechanisms,which include exploring and optimizing the application standards of elec-tronic drug regulatory licenses based on the national integrated online government service platform,expanding the application scenarios of electronic drug regulatory licenses,building an efficient,high-quality,convenient,safe,and trustworthy electronic drug regulatory license service system,achieving cross regional and cross departmental sharing of electronic drug regulatory licenses and mutual trust and recognition nationwide,so as to provide reference for further leveraging the role of electronic licenses in government services,enhancing intelligent drug supervision,and promoting high-level social governance.

关 键 词：药品监管 电子证照 药品注册证 药品生产许可证 应用场景 

分 类 号：R95[医药卫生—药学]