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

Abstract:

With the deepening of "Internet plus government service"， each regions and departments are actively promoting the application 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 electronization 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 electronic 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.

Key words: Drug regulation； , Electronic license； , Drug registration certificate； , Drug production license； , Application scenarios