我国药物警戒发展历程及趋势分析 点击下载
| 论文标题： | 我国药物警戒发展历程及趋势分析 |
| 英文标题： | |
| 中文摘要： | 药物警戒贯穿药品全生命周期。本文系统梳理了我国药物警戒的发展历程，从初步建立药品不良反应报告制度，到逐步构建起与国际接轨的完整药物警戒体系，重点分析了该过程中组织体系、法制体系、监测系统的变迁特征，并在此基础上，深入探讨了我国药物警戒的未来发展趋势。总体而言，我国药物警戒体系在法规建设与实践操作上均取得了显著进展，未来还应继续完善药物警戒体系（如加速落实“一体两翼”工作格局、强化药品上市许可持有人主体责任）、加强专业人才队伍的培养与储备、加强信息化建设（如完善自发呈报系统、构建主动监测系统），从而为保障公众用药安全、促进医药产业高质量发展提供更加坚实的支撑。 |
| 英文摘要： | Pharmacovigilance runs through the whole life cycle of drugs. This paper systematically sorts out the development course of pharmacovigilance in China， from the initial establishment of the adverse drug reaction reporting system to the gradual construction of a complete pharmacovigilance system aligned with international standards. It focuses on analyzing the evolutionary features of the organizational system， legal system and monitoring system during this process. On this basis， this paper further discusses the future development trends of pharmacovigilance in China. In general， remarkable progress has been achieved in both regulatory construction and practical implementation of China’s pharmacovigilance system. In the future， efforts should be continuously made to improve the pharmacovigilance system， such as accelerating the implementation of the “one-body with two-wings” working framework and strengthening the primary responsibility of marketing authorization holders. It is also necessary to cultivate and reserve professional talents and promote information-based construction， including optimizing the spontaneous reporting system and establishing active monitoring systems. These measures can provide more solid support for ensuring public drug safety and facilitating high-quality development of the pharmaceutical industry. |
| 期刊： | 2026年第37卷第17期 |
| 作者： | 李红玲；张玉蓉；覃正碧；郑明节；赵丽 |
| 英文作者： | LI Hongling，ZHANG Yurong，QIN Zhengbi，ZHENG Mingjie，ZHAO Li |
| 关键字： | 药物警戒；药品不良反应；药品全生命周期；信息化建设；发展历程 |
| KEYWORDS： | adverse drug reaction;whole life cycle of medicinal products;information-based construction;development course |
| 总下载数： | 81次 |
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| 文件大小： | 619.60Kb |
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