国家药品监管电子证照探索与实践

Exploration and Practice of Electronic Certificate by the National Medical Products Administration

本文介绍了电子证照概念及国家药品监管电子证照工作实施背景,分析了药品监管证照现状,阐述了国家药监局涉企证照电子化的工作思路以及取得的成效,并探索性地提出国家药品监管电子证照工作存在的问题,并给出相关对策建议,以期为完善我国药品监管电子证照工作提供参考。

This paper introduces the concept and the policy background of electronic certificate by the National Medical Products Administration(NMPA).It analyzes the current situation of drug regulatory certificate and elaborates the NMPA’s approach and achievements in implementing electronic certificate for enterprises.It exploratively proposes the existing problems in the electronic certificate process of the NMPA,and puts forward relevant countermeasures and suggestions,aiming to provide references for improving the electronic certificate work for drug regulation in China.