新时代国家药物警戒管理体系建设思考

doi:10.19803/j.1672-8629.20240861

摘要/Abstract

摘要： 目的分析新时代、新形势下药物警戒工作的内涵,总结药物警戒的实践与思考,为国家药物警戒管理体系建设提供参考。方法以法治、体制机制建设为线索,从药物警戒工作的历史沿革,分析其取得的成绩及不足,提出进一步完善与提高药物警戒工作的思考。结果药物警戒贯穿药品的全生命周期,聚焦风险管理,为药品监管提供有力技术支撑。药物警戒制度实施以来,法律体系、制度体系、组织体系、专业能力逐步建立、完善和提高,同时也存在较大提升空间。结论建议持续推进药物警戒工作科学化、规范化、制度化,全方位筑牢药品安全底线,助推药品监管和药品行业高质量发展。

关键词: 药物警戒, 风险管理, 管理体系, 药品监管, 监管科学

Abstract: Objective To analyze what pharmacovigilance is about in the new era and under new circumstances and summarize related experience in order to provide a reference for the construction of a national pharmacovigilance management system. Methods Based on related laws and regulations as well as the construction of systems and mechanisms, the achievements and downsides of pharmacovigilance in China were analyzed in terms of the evolution of pharmacovigilance, and ways to improve pharmacovigilance were recommended. Results Pharmacovigilance runs through the whole life cycle of drugs and focuses on risk management, providing strong technical support for regulation of pharmaceuticals. Since the implementation of pharmacovigilance, the legal system, regulatory system, organizational system, and professionalism have been gradually established and improved, but there is also much room for improvement. Conclusion It is recommended that more efforts be made to make pharmacovigilance more scientific, standard and legalized, and that a solid bottom line for drug safety be established to promote the high-quality development of pharmacovigilance and the pharmaceutical industry.

Key words: Pharmacovigilance, Risk Management, Management System, Regulation of Drugs, Regulatory Science

中图分类号:

R951
R994.11

杨旭云, 孙阳, 田春华, 胡增峣. 新时代国家药物警戒管理体系建设思考[J]. 中国药物警戒, 2025, 22(3): 276-281.

YANG Xuyun, SUN Yang, TIAN Chunhua, HU Zengyao. A National Pharmacovigilance Management System in a New Era[J]. Chinese Journal of Pharmacovigilance, 2025, 22(3): 276-281.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I3/276

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