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Outline
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.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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