| 杨悦.深刻领会新《药品管理法》中体现的“四个最严”监管[J].中国药事,2019,33(11):1206-1211 |
| 深刻领会新《药品管理法》中体现的“四个最严”监管 |
| Deeply Understanding the “Four Strictest” Supervision Embodied in the New Drug Administration Law |
| 投稿时间：2019-10-11 |
| DOI：10.16153/j.1002-7777.2019.11.001 |
| 中文关键词: 四个最严 药品管理法 监管 处罚 问责 |
| 英文关键词: the “Four Strictest” the Drug Administration Law regulation punishment accountability |
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| 中文摘要: |
| 目的：深刻领会新《药品管理法》条款体现的"四个最严"精神。方法：通过对新《药品管理法》中的制度框架、相关条款的分析，并与现行《药品管理法》对照理解"四个最严"的涵义。结果与结论：药品标准体系和执行要求等条款当中体现最严谨的标准。引入追溯制度、药物警戒制度等创新管理制度，体现最严格的监管。法律责任部分综合运用多种处罚方式，大幅提高处罚力度，体现最严厉的处罚。在执行层面，药品监管系统需要全面升级，避免属地监管形成信息孤岛，出现信息不通、信息无法共享的问题，实现跨部门、跨属地、跨监管层级的信息互通、共享和互认。《药品管理法》此次大规模修订，将推动我国药品监管的国际化、现代化进程。 |
| 英文摘要: |
| Objective:To deepen the understanding of the "Four Strictest" supervision embodied in the provisions of the Drug Administration Law (DAL). Methods:The institutional framework and relevant provisions in the new DAL were analyzed and compared with those of the current DAL to understand the meanings of the "Four Strictest". Results and Conclusion:The most rigorous standards are embodied in the drug standard system and the implementation regulation. The introduction of innovative management system, such as traceability system and pharmacovigilance system reflects the strictest supervision. In the part of legal responsibilities, a variety of punishments are comprehensively used to greatly increase the punishment intensity and reflect the most severe punishment. As to the implementation level, the drug regulatory system needs to be upgraded in all respects to avoid the problems that the territorial supervision became an isolated information island, the information was blocked and the information could not be shared so as to achieve information exchanging, sharing and mutual recognition across departments, provinces and regulatory levels. This large-scale revision of DAL will promote the internationalization and modernization of drug supervision in China. |
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