【摘要】 真实世界数据（RWD）是指从真实医疗环境中获得的数据，真实世界证据（RWE）是基于RWD形成的证据，二者在监管科学领域具有独特价值。在药品审评审批、药物安全性评价等环节，RWE可作为支持监管决策的补充证据，为监管工作提供有力的支持。本文通过分析国内外监管机构对RWE的运用情况，结合成功应用实例，探讨RWE在不同国家和地区的实践特点。尽管RWE应用日益广泛，但其使用过程中仍面临数据标准化不足、隐私保护不健全以及解读复杂度较高等挑战。为应对这些挑战，建议建立数据隐私保护框架，提升数据标准化水平，提高专业人员的数据分析能力等。未来，可考虑从完善政策法规、推动技术创新以及深化跨领域合作等方面持续推动RWD与RWE的发展，以加强其在药品监管中的应用，从而更好地服务于公众健康需求。更多还原

【Abstract】 Real-world data(RWD) refers to data collected from real-world medical settings, and real-world evidence(RWE) is evidence derived from such data. Both hold unique value in the field of regulatory science. In areas such as drug review and approval, drug safety evaluation, RWE can serve as supplementary evidence to support regulatory decision-making, providing substantial support for regulatory work. This paper analyzes the application of RWE by regulatory agencies worldwide and discusses its practical characteristics in different countries and regions, drawing on successful examples. Despite the growing application of RWE, challenges remain in its utilization, including insufficient standardization, inadequate privacy protection, and high complexity in interpretation. To address these challenges, it is recommended to establish data privacy protection frameworks, enhance data standardization, and improve professionals’ data analysis capabilities. The development of RWD and RWE can be further advanced by improving policies and regulations, promoting technological innovation, and deepening crossfield cooperation. This will strengthen their application in drug regulation and better serve public health needs.更多还原