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.
关键词
药品监管/电子证照/实现路径/实践成效/工作难点
Key words
drug regulation/electronic certificate/implementation path/practical effectiveness/work difficulties