生物医药产业正以前所未有的速度发展，其研发数字基础设施体系的建设和完善是国家生物科技创新和健康中国建设的重要基石。本文论述了生物医药研发数字基础设施的内涵与新时期生物医药研发数字基础设施的分类和系统体系；总结了美国、欧盟和我国生物医药研发数字基础设施战略布局的现状及发展路径，梳理了我国生物医药研发数字基础设施建设在国际影响力和权威性、发展模式设计和效能、可持续建设、管理组织架构建设方面与欧美国家存在的差距及在顶层设计、管理治理方面面临的挑战。研究建议，加强生物医药研发数字基础设施顶层设计，加强生物医学和健康医疗资源的统筹编排，加强单一个体平台集群化整合建设和治理，加强开放平台能力建设和运营保障。

The biomedical industry is developing at an unprecedented speed and the establishment and improvement of a digital infrastructure for biomedical research and development (R&D) is crucial for biotechnology innovation and Health China construction. This study analyzes the implication, classification, and systematic framework of the digital infrastructure for biomedical R&D in the new era. It summarizes the strategic layouts and development paths of the digital infrastructures for biomedical R&D in the United States, the European Union, and China, and examines the gap between China and European and American countries in terms of international influence and authority, development model design and efficiency, sustainability, and management organization construction. Moreover, it presents the challenges faced by the digital infrastructure of China regarding top-level design, management, and governance. Furthermore, we suggest that the following aspects should be strengthened: top-level framework design, coordination of biomedical and healthcare resources, clustered construction and governance of the platform, and capacity building and operationguarantee of the open platform.