儿童药品临床综合评价作为上市后再评价的一种规范管理形式，从多维度全面评价儿童药品的综合价值，通过专家组打分进行指标赋分和分值计算，最终形成推荐意见，为儿童药品管理决策提供有力的支撑，优化医疗资源的配置、保障儿童药品安全。目前我国儿童药品临床综合评价机制包括出台了专门的管理指南和评价技术指南，采用多维度评价标准，采用多种评价方法，确立结构化的评审流程。我国儿童药品临床综合评价体系正在逐步构建和完善中，存在立法不完善、评价维度不统一、临床创新性界定模糊、真实世界数据机制和评价结果转化机制不完善等问题，导致评价工作与实际药品监管和药品供应保障之间脱节。为应对未来挑战，应从加强立法、合理选择评价维度、完善儿童药品创新性评估体系、健全真实世界数据机制、建立有效的评价决策支持机制等方面完善儿童药品临床综合评价体系，从而解决儿童用药保障问题、提升儿童健康水平。

As a standardized management form of post-marketing reevaluation, clinical comprehensive evaluation of pediatric drugs conducts multi-dimensional assessment of their comprehensive value. Through expert panel scoring for indicator weighting and score calculation, it ultimately forms recommendation opinions. This process provides strong support for pediatric drug management decisions, optimizes allocation of medical resources, and ensures medication safety for children. Current clinical evaluation mechanisms in China include issuing specialized management guidelines and technical evaluation standards, adopting multidimensional evaluation criteria, utilizing various assessment methods, and establishing structured review processes. While China's clinical comprehensive evaluation system for pediatric drugs is gradually being established and improved, existing challenges include incomplete legislation, inconsistent evaluation dimensions, ambiguous definitions of clinical innovation, inadequate real-world data mechanisms, and imperfect evaluation result transformation systems. These issues lead to disconnections between evaluation practices and actual drug regulation/supply systems. To address future challenges, improvements should focus on strengthening legislation, rationally selecting evaluation dimensions, perfecting pediatric drug innovation assessment systems, optimizing real-world data mechanisms, and establishing effective evaluation decision-support mechanisms. This comprehensive approach aims to resolve pediatric medication security issues and enhance child health outcomes.

R97

北京市社会科学基金项目-北京共建共治共享的药品安全治理体系研究（19GLB032）