关键词:  , 药品监管；信息化；标准；标准化建设；湖北省

Abstract:

The construction of drug regulation informatization is the fundamental guarantee for achieving information sharing， business collaboration and safe operation， and promoting digital transformation. The constraction of standardization system is a foundational project for the implementation of digital government construction and the advancement of smart supervision.To understand the current status of relevant standards in the field of drug regulation informatization， this study searched for relevant standards included in the National Standard Information Public Service Platform， and sorted out 317 drug regulation informatization related standards applicable for Hubei Province， including 215 national standards， 63 industry standards， 10 local standards， and 29 association standards.The current situation of drug regulation informatization standards in Hubei province is analyzed from various dimensions， including the current status of the standards， their level and nature， classification， age （duration since issuance）， and the year of publication.This study pointed out issues in the current drug regulation informatization standards system， such as excessively long ages of some standards， insufficient numbers of standards in certain categories， and inadequate coverage and specificity of standards. Finally， this study put forward some suggestions such as establishing and improving a mechanism for standard formulation and revision， strengthening the formulation of standards in key areas， enhancing the coverage and pertinence of standards， and coordinating the development of various standards， so as to improve the drug regulation informatization standards system and provide more comprehensive， scientific and effective support for drug supervision.

Key words: Drug regulation； , Informatization； , Standards； , Standardized construction； , Hubei province