ObjectiveTo systematically review the classification system for the causes of pediatric drug shortages in China, and classify the causes of pediatric drug shortages accurately, so as to provide references for the formulation of targeted strategies. MethodsFour databases including Embase, PubMed, CBM and CNKI were searched from inception to November 2023. Quantitative research, qualitative research and mixed-method research on the causes of pediatric drug shortages in China were included. Two researchers independently screened the literature and extracted data. Based on the theory of efficient market and effective government, and according to the life cycle of the drug supply chain, the fundamental causes of drug shortages were classified and summarized by thematic synthesis. ResultsFourteen articles were included. According to the four stages of the drug supply chain (research and development, production, circulation and use), a total of 19 categories of causes of the pediatric drug shortages were summarized, including 5 categories in the research and development stage, 4 categories in the production stage, 6 categories in the circulation stage, and 4 categories in the use stage. Based on the theory of efficient market and effective government, further analysis of the causes revealed that the identified reasons could be attributed to three major fundamental causes: market failure, government failure, and other causes. Among them, 6 categories were related to market failure, 7 categories were related to government failure, and 6 categories were classified as other causes. ConclusionBased on the theory of efficient market and effective government, this study established a classification system of fundamental causes of the pediatric drug shortages, and made policy suggestions accordingly. Subsequently, the classification system established in this study can be used as references to develop targeted strategies to solve the problem of pediatric drug shortages in the life cycle of drug supply chain from government and market perspectives.