美国临床试验用药物扩大使用制度沿革与发展

发布时间：2018-05-16 21:25

本文选题：临床试验 + 扩大使用　；参考：《中国新药杂志》2017年16期

【摘要】：通过查阅美国法律法规、指南文件、国内外文献,深入分析美国扩大使用临床试验用药物的立法背景、制度要素以及实施现状,为我国临床试验用药物扩大使用相关法规建立提供建议。美国扩大使用制度经历了雏形、初建、发展完善3个阶段。美国临床试验用药物扩大使用法律定义明确且具有灵活性;扩大使用监管对象按患者数量和风险控制划分3类;扩大使用申请要求与批准程序根据申请类型、申请主体简化安排;风险保障措施完备,包括知情同意、伦理审查、安全报告。建议我国从保护和促进公众健康出发,引入建立适合我国国情的扩大使用制度,并明确扩大使用的类型和适用情况;建立扩大使用申请和简化程序;采取必要的患者保障和风险控制措施。
[Abstract]:By consulting the laws and regulations of the United States, guidance documents, domestic and foreign literature, the legislative background, institutional elements and implementation status of the expanded use of drugs for clinical trials in the United States are analyzed in depth. To provide suggestions for the establishment of laws and regulations related to the expanded use of drugs for clinical trials in China. The expanded use system of the United States has experienced three stages: embryonic form, initial construction and development and perfection. The expanded use of drugs in clinical trials in the United States has a clear legal definition and flexibility; the expanded use of drugs is regulated by three categories by patient number and risk control; and the application requirements and approval procedures for expanded use are based on the type of application, Simplified arrangements for applicants; complete risk safeguards, including informed consent, ethical review, and safety reports. In order to protect and promote public health, it is suggested that China should introduce and establish an expanded use system suitable for China's national conditions, and make clear the types and application conditions of the expanded use, establish the application for expanded use and simplify the procedures. Take necessary patient protection and risk control measures.
【作者单位】：沈阳药科大学工商管理学院;国际食品药品政策与法律研究中心;
【基金】：国家食品药品监督管理总局课题(20160003)
【分类号】：R951

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