《药品不良反应报告和监测管理办法》修订思考

doi:10.19803/j.1672-8629.20250657

摘要/Abstract

摘要： 目的回顾《药品不良反应报告和监测管理办法》发展历程,探讨办法修订的主要任务及内容的思考,为其修订工作提供参考。方法系统梳理《药品不良反应监测管理办法（试行）》（1999年）的颁布情况和《药品不良反应报告和监测管理办法》（2004年、2011年）的2次修订背景、主要内容及在推动药品不良反应监测工作中发挥的作用,分析《药品不良反应报告和监测管理办法》目前修订的主要任务,从技术角度阐述对修订内容的思考。结果《药品不良反应报告和监测管理办法》的修订工作充分反映了当前监管工作的需要,紧密结合了药品不良反应监测工作的实际,有力推动了药品不良反应监测工作的发展。《药品不良反应报告和监测管理办法》修订的首要任务是贯彻落实《中华人民共和国药品管理法》“国家建立药物警戒制度”的要求,需注重相关法规政策衔接,做好传承与创新。《药品不良反应报告和监测管理办法》修订内容需厘清报告范围、优化报告要求,突出风险控制、强化监督管理。结论《药品不良反应报告和监测管理办法》修订工作任重道远,对我国未来5年、10年或者更长时间内药物警戒有一定的指导意义,将推动我国药物警戒工作迈入新的发展阶段。

关键词: 药物警戒, 药品不良反应, 药品不良反应监测, 药品监管, 法规体系

Abstract: Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development.

Key words: Pharmacovigilance, Adverse Drug Reactions, Adverse Drug Reaction Monitoring, Drug Supervision, Legal System

中图分类号:

R951
R994.11

田春华. 《药品不良反应报告和监测管理办法》修订思考[J]. 中国药物警戒, 2025, 22(11): 1253-1257.

TIAN Chunhua. Revision of the Provisions for Adverse Drug Reactions Reporting and Monitoring[J]. Chinese Journal of Pharmacovigilance, 2025, 22(11): 1253-1257.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I11/1253

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