| 陈云,任磊,颜建周,谢金平,邵蓉.MAH制度下日本药品不良反应损害救济基金制度研究[J].中国药事,2017,(12):1395-1403 |
| MAH制度下日本药品不良反应损害救济基金制度研究 |
| Study on Japanese Adverse Drug Reaction Injury Relief Fund System under MAH |
| 投稿时间：2017-08-11 |
| DOI：10.16153/j.1002-7777.2017.12.004 |
| 中文关键词: 药品上市许可持有人 日本 不良反应 救济基金 基金管理部门 筹资模式 救济范围和标准 运行程序 |
| 英文关键词: marketing authorization holder Japanese adverse drug reaction relief fund fund management department fund-raising pattern relief scope and standards operating procedure |
| 基金项目:2015年度国家社科基金重大项目（第二批）《我国创新药物政策环境研究》基金资助（编号15ZDB167） |
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| 中文摘要: |
| 目的：建立药品不良反应损害救济基金制度，更好地推进我国药品上市许可持有人（MAH）制度试点工作。方法：对日本药品不良反应损害救济基金制度的具体内容进行分析，对其基金来源、支付标准、申请流程做了重点研究。结果：日本药品不良反应损害救济基金制度主要通过对MAH征收合理的缴纳金，来平衡民众的合法权益以及保证医药产业健康发展之间的关系。结论：结合具体国情，建议我国从法律层面明确建立药品不良反应损害救济基金制度，制定药品不良反应损害救济实施办法，从基金管理部门（行政主管部门、技术鉴定机构、基金管理运作机构）、筹资模式、救济范围、救济标准、运行程序、监督管理、制度宣传等各个方面做出详细规定，切实保证药品不良反应损害救济制度的可操作性。 |
| 英文摘要: |
| Objective: To establish adverse drug reaction injury relief fund system and to better promote the pilot work of marketing authorization holder (MAH) system in China. Methods: The contents of Japanese adverse drug reaction injury relief fund system were analyzed, and its fund source, payment standard and application process were emphasized. Resuults: Japanese adverse drug reaction injury relief fund system balances the legitimate rights of people and the healthy development of the pharmaceutical industry by collecting reasonable payment from MAHs. Conclusion: Combined with specifc national situation, it was recommended that adverse drug reaction injury relief fund system should be established from the legal level, "Implementing Rules for Adverse Drug Reaction Injury Relief" should be promulgated, detailed provisions should be made for the following aspects, such as fund management departments (administrative departments, technical appraisal institutions, fund management institutions), fund-raising pattern, relief scope and standards, operating procedures, supervision and management,system publicity and so on to effectively ensure the operability of adverse drug reaction injury relief fund system. |
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