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澳大利亚药品特别准入计划对完善我国同情用药制度的启示
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篇名: 澳大利亚药品特别准入计划对完善我国同情用药制度的启示
TITLE: Enlightenment of Australia ’s Drug Special Access Scheme to th e Improvement of China ’s Sympathetic Drug Use System
摘要: 目的:为完善我国同情用药制度体系提供国外经验借鉴。方法:对澳大利亚药品特别准入计划(SAS)的申请人、药品范围、申请途径、处理流程、主体职责、费用支付等具体内容进行先容和分析,并对我国同情用药相关制度的完善提出建议。结果与结论:澳大利亚医疗用品管理局(TGA)根据病情的严重程度以及药品安全性将SAS分为3类通道,对于病情十分紧急的患者可通过SAS-A类通道,对于安全性相对较高的药品可通过SAS-C类通道,通知TGA后即可直接使用未批准药品;其他情况需通过SAS-B类通道以“申请-审评”的形式向TGA提出申请,经审评通过后方可实现同情用药。澳大利亚SAS制度体系对医师、政府监管机构、赞助商的相关职责均作了详细规定,形成了相对完善的制度体系。建议我国建立多种同情用药申请通道,构建多层次同情用药评估体系,并与现有制度有机衔接,以构建完善的同情用药体系,提高药品的可及性,使药物研发成果能够更加及时地惠及临床。
ABSTRACT: OBJECTIVE:To provid e foreign experience for the improvement of sympathetic drug use system in China. METHODS:Australia’s Special Access Scheme (SAS) was introduced and analyzed in respects of applicant ,drug scope , application method ,processing flow ,main responsibilities ,drug payment and other specific content. The suggestion were put forward for the improvement of sympathetic drug use system in China. RESULTS & CONCLUSIONS :Therapeutic Goods Administration(TGA)divided SAS into 3 channels according to disease severity and drug safety ,the patients with very urgent medical conditions could use drugs directly through SAS-A channel ,and unapproved drugs with relatively high safety can also be used directly through SAS-C channel after informing TGA ;in other conditions ,drugs can be used through SAS-B channel by the form of “application-evaluation”after approved by TGA. At the same time ,Australia has made detailed regulations on the responsibilities of doctors ,government regulators and sponsor in the system ,forming a relatively perfect system. In order to improve compassionate use system ,improve the feasibility of drugs ,make drug research and development results more timely benefit clinical ,it’s suggested that we should establish multiple application channels ,construct the multi-level drug evaluation system and connect with the existing system well.
期刊: 2020年第31卷第12期
编辑: 任磊,张丽杨,韩丹,柴逸峰,张黎,舒丽芯
AUTHORS: REN Lei,ZHANG Liyang ,HAN Dan,CHAI Yifeng ,ZHANG Li,SHU Lixin
关键字: 澳大利亚;特别准入计划;同情用药制度
KEYWORDS: Australia;Special Acce ss Scheme ;Sympathetic drug use system
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