欧洲药品监管数据应用研究与思考

Research and consideration on the application of the European drug regulatory data

摘要

随着药品审评审批改革深化和数字技术迅猛发展,药品审评数据作为药品监管领域的重要基础资源,加强其应用对提升药品审评效率与推动模式转型具有重要意义。本研究基于欧洲药品监管数据,从数据战略、数据质量、数据保护及数据应用等方面展开分析,并就高质量数据管理体系构建、数据应用价值释放以及利益相关者协同机制等提出思考,以期为我国药品审评数据研究和应用提供参考,促进药品审评数据要素价值释放,助力药品审评数智化高质量发展。

Abstract

With the deepening of drug review and approval reform and the rapid development of digital technology, it is of great significance to enhance the application of drug review data, as an important basic resource in the field of drug review, for the efficiency improvement and mode transformation of drug review. Based on the European drug regulatory data, this study analyzed data strategy, data quality, data protection, and data application, and proposed ideas on high-quality data management system, data application value release, and stakeholder collaboration mechanism, in order to provide references for the research and application of drug review data in China, promote the value release of data elements, and assist in the high-quality development of drug review digitalization and intelligence.

关键词

药品审评数据 / 基础资源 / 价值释放 / 数智化 / 高质量发展

Key words

drug review data / basic resources / value release / digitalization and intelligence / high-quality development

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基金资助

药品监管科学全国重点实验室资助项目(2025-SKLDRS0369)