儿童个性化调剂监管国际经验借鉴

International experience in the supervision of personalized compounding of medicines for children

摘要

为应对我国儿童个性化调剂监管体系缺失的挑战,本研究旨在系统梳理国际监管经验,以期为构建覆盖研发、生产、使用及支付全流程的本土化监管框架提供参考。 采用文献分析与比较研究法,系统剖析美国、日本和欧洲的政策法规与监管实践。 美国和欧洲通过专项立法构建了“强制+激励”的监管体系;日本则建立了基于风险的院内制剂分级管理制度。各国普遍通过专门文件规范人员资质、辅料安全与操作流程,且均已形成了体现药学服务价值的调剂价格补偿机制,本研究以推动儿童用药立法、建立分级管理制度、推行“强制+激励”的监管政策、构建辅料安全数据库,探索将个性化调剂服务纳入医保支付的合理补偿机制,从而系统性保障儿童用药安全与可及性。

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.

关键词

儿童 / 个性化制剂 / 国际经验 / 监管政策 / 药物调剂

Key words

children / personalized formulation / international experience / regulatory policy / drug compounding