药品监管信息化建设工作是实现信息共享、业务协同及安全运行，推动数字化转型的基础保障。标准化体系建设是实施数字政府建设、推进智慧监管的基础性工程。为了解药品监管信息化领域相关标准现状，本研究检索了全国标准信息公共服务平台收录的各类相关标准，梳理出适用于湖北省实际的药品监管信息化相关标准317项，包含国家标准215项，行业标准63项，地方标准10项，团体标准29项，并从标准状态、标准级别及性质、标准分类、标准标龄与发布年份等不同维度，分析介绍了湖北省药品监管信息化标准现状，提出当前药品监管信息化标准体系中存在部分标准标龄过长、部分类别标准数量不足、标准覆盖面及针对性不强等问题。本研究建议应建立健全标准制修订机制，加强关键领域标准制定，提高标准覆盖面和针对性，协调各类标准发展，从而完善药品监管信息化标准体系，为药品监管工作提供更加全面、科学、有效的支持。

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.