International experience in the supervision of personalized compounding of medicines for children
GONG Yu-chen
WANG En-nan
MEI Dong
XI Xiao-yu
WANG Xiao-ling
Abstract：In response to the lack of a regulatory framework for personalized compounding of medicines for children in China,this study aims to systematically review international regulatory experience to provide a reference for constructing a localized regulatory framework covering the entire process of research and development,production,compounding,and insurance reimbursement.Using literature analysis and comparative study methods,the regulatory policies and practices of the United States,Japan,and Europe were systematically analyzed.The US and the EU have established a"combination of mandates and incentives"regulatory system through specific legislation.Japan has implemented a risk-based hierarchical management system for hospital-prepared medicines.Various countries commonly regulate personnel qualifications,excipient safety,and operational procedures through dedicated documents and have established pricing and reimbursement mechanisms that reflect the value of pharmaceutical compounding services.To systematically ensure the safety and accessibility of medicines for children,it is essential to promote legislation on pediatric medications,establish a hierarchical management system,implement a"mandatory+incentive"regulatory policy,build an excipient safety database,and explore a reasonable reimbursement mechanism for integrating personalized compounding services into health insurance payment.
Keywords：childrenpersonalized formulationinternational experienceregulatory policydrug com-pounding
Publication Date：2026-05-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 1009-1016 )