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美国、欧盟、日本药品再评价的法律制度研究及对我国的启示
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| 篇名： | 美国、欧盟、日本药品再评价的法律制度研究及对我国的启示 |
| TITLE： | |
| 摘要： | 目的：为我国建立和完善药品再评价制度提供参考。方法：查阅并总结美国、欧盟、日本药品上市后再评价的相关法律制度，分析我国在药品再评价工作方面的不足，并提出完善建议。结果与结论：美国、欧盟、日本均对药品上市后再评价制定了相关法律及制度，还有具体的实施规范和技术支撑计划。美国药品再评价法律制度可分为药品不良反应的监测与报告制度、药品上市后研究制度和药品安全风险主动监测系统；欧盟主要有针对常规上市药品、特殊情况或条件许可药品的监测与评价制度，以及药品再注册制度；日本的再评价法律制度主要由再审查制度和再评价制度等组成。而我国药品再评价工作尚存在体系性不强，立法层面薄弱、可操作性和震慑力不足，药品再评价结果的落实与应用环节未能得到有效衔接，资源未得到有效配置等不足。建议我国可整合已有再评价相关制度，从药品再评价法律制度体系的系统构建、立法层面的建设和规范、再评价法律制度体系的衔接及资源的配置三方面入手，完善我国药品再评价法律制度体系。 |
| ABSTRACT： | OBJECTIVE： To provide reference for the establishment and improvement of drug reevaluation system in China. METHODS： The design and relevant laws of drug reevaluation system in America， European Union and Japan were reviewed and summarized. The shortcomings of drug evaluation in China were analyzed and suggestions for improvement were put forward. RESULTS & CONCLUSIONS： America， European Union and Japan have formulated relevant laws and systems for post-marketing reappraisal of drugs， as well as specific implementation norms and technical support plans. The legal system of drug reevaluation in America can be divided into ADR monitoring and reporting system， post-marketing drug research system and active drug safety risk monitoring system. The European Union mainly has a monitoring and evaluation system for conventionally marketed drugs， drugs licensed under exceptional circumstances or conditions， and a re-registration system for drugs. Japan’s legal system of reevaluation mainly consists of reexamination system， reevaluation system and other systems. However， there are still some shortcomings in the drug reevaluation in our country， such as weak system， weak legislation， inadequate operability and deterrence， ineffective links between the implementation and application of drug evaluation results， and ineffective allocation of resources. It is suggested that we should integrate the existing reevaluation system to improve the legal system of drug reevaluation in China，starting from the systematic construction of the legal system of drug reevaluation， the construction and standardization of the legislative level， the connection of the legal system of drug reevaluation and the allocation of resources. |
| 期刊： | 2019年第30卷第18期 |
| 作者： | 张琪，颜建周，姚雯，邵蓉 |
| AUTHORS： | ZHANG Qi，YAN Jianzhou，YAO Wen，SHAO Rong |
| 关键字： | 药品再评价；法律制度；美国；欧盟；日本；中国；启示 |
| KEYWORDS： | Drug reevaluation； Legal system； America； European Union； Japan； China； Enlightenment |
| 阅读数： | 510 次 |
| 本月下载数： | 11 次 |
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