目的 制定《儿童中成药研发目录建议清单》，为促进儿童中药创新研发提供参考依据。方法 以儿科领域临床优势病种为切入点，以儿童中成药“未满足的临床需求”为导向，通过文献计量法、专家问卷调查法和专家论证会等循证医学方法，立足国家中药研发制度，系统梳理儿童中成药应用现状，儿科临床疾病诊疗需求及现有人用经验等，形成清单证据体。结果 制定了涉及10个系统包含22个优势病种的《儿童中成药研发目录建议清单》。整体上明确了儿童中成药新药的两大研发思路：一是老药新用，增加完善儿童用法用量；二是进行新药研发。结论 《儿童中成药研发目录建议清单》的制定为儿童用药不足的关键问题提出方向性的解决策略，有力地推动儿童中成药新药的研发上市。

Objective To formulate "Development Catalogue Suggested List of Chinese Patent Drug for Children", in order to provide a reference for promoting innovative research and development of traditional Chinese medicines (TCM) for children. Methods Taking clinical advantage diseases in the field of pediatrics as the starting point, guided by the "unmet clinical needs" of children's Chinese patent drug, through evidence-based medicine methods such as literature measurement method, expert questionnaire survey method and expert demonstration meeting, based on the national TCM research and development system, systematically sorted out the application status of children's Chinese patent drug, clinical disease diagnosis and treatment needs of pediatrics and existing human use experience, and formed a list of evidence. Results "Development Catalogue Suggested List of Chinese Patent Drug for Children" involving 22 advantageous diseases in 10 systems was developed. On the whole, it is clear that the first is the new use of old drugs, increase and improve the usage and dosage of children, and the second is the two major research and development ideas of new Chinese patent drugs for children. Conclusion The formulation of "Development Catalogue Suggested List of Chinese Patent Drug for Children" puts forward directional solutions to the key problems of insufficient medicines for children, and effectively promotes the research and development of new medicines for children.

中华中医药学会求实项目（儿科专项）资助项目（2022-QSEKZX-01）；第五批全国中医临床优秀人才研修项目（国中医药办人教函［2021］271号）；中医药传承与创新“百千万”人才工程（岐黄工程）岐黄学者（国中医药人教发［2018］12号）