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中国医药导刊 ›› 2026, Vol. 28 ›› Issue (2): 135-135-140.doi: 10.1009-0959.2026.030003

• 监管科学 • 上一篇    下一篇

基于新质生产力政策背景的药物警戒人才需求特征分析和体系建设

张梅珍1, 柳鹏程2*, 陈磊3   

  1. 1.中国药科大学继续教育学院,江苏 南京 210009;

    2.中国药科大学国际医药商学院,江苏 南京 210009;

    3.安徽艾立德制药有限公司,安徽 安庆 246005
  • 收稿日期:2025-04-22 修回日期:2025-10-02 接受日期:2026-03-18 出版日期:2026-02-28 发布日期:2026-03-19
  • 基金资助:
    国家自然科学基金资助项目(72474225)

Demand Profile Analysis and System Construction of Pharmacovigilance Talents under the Policy Background of New Quality Productive Forces

ZHANG Meizhen1, LIU Pengcheng2*, CHEN Lei3   

  1. 1.School of Continuing Education China Pharmaceutical University Jiangsu Nanjing 210009, China
    2.School of International Pharmaceutical Business China Pharmaceutical University Jiangsu Nanjing 210009, China
    3.Anhui Ailead Pharmaceutical Co. Ltd. Anhui Anqing 246005, China
  • Received:2025-04-22 Revised:2025-10-02 Accepted:2026-03-18 Online:2026-02-28 Published:2026-03-19

摘要:

药物警戒工作对及时发现、评估、预防药品不良反应至关重要,是保障公众用药安全、维护公共健康的关键防线。在新质生产力背景下,对标生物医药产业升级战略,我国药品监管部门通过推进监管体系和创新模式的国际化进程,驱动医药行业加速创新研发能力迭代。本研究聚焦新质生产力政策背景下我国医药企业药物警戒人才需求,以324家医药企业的药物警戒从业人才为样本剖析其特征,发现药物警戒作为药品全生命周期风险管理的核心,人才短缺问题突出;目前药物警戒人才专业背景中,药学专业占比较高,但药品安全性监测与国际药物流行病学融合应用亟待加强;影响药物警戒人才需求的三大制约因素为政策法规、行业发展及技术进步;构建药物警戒人才体系存在与法规适配、多学科融合、供需平衡、创新力等诸多挑战。建议通过加强政策引导与产研学用多方协同,构建高质量、稳定的药物警戒人才梯队,以满足医药行业高质量创新发展人才需求,保障公众用药安全。


关键词: 药物警戒, 新质生产力, 人才需求, 创新, 国际化

Abstract:

Pharmacovigilance is crucial for the timely identification assessment and prevention of adverse drug reactions serving as a critical safeguard for public medication safety and public health protection. Under the background of new quality productive forces and in line with the upgrade strategy of biopharmaceutical industry Chinas drug regulatory authorities are advancing the internationalization of regulatory systems and innovative models to accelerate the iterative upgrades in pharmaceutical innovation and R&D capabilities. This study focuses on the demand for pharmacovigilance talents in China's pharmaceutical enterprises under the policy background of new quality productive forces. Taking the pharmacovigilance practitioners from 324 pharmaceutical enterprises as samples this study analyzes their characteristics and finds that pharmacovigilance as the core of drug full life cycle risk management faces prominent talent shortages. While professionals with pharmaceutical science backgrounds constitute a relatively high proportion of current pharmacovigilance personnel the integration of drug safety monitoring with international pharmacoepidemiology requires significant strengthening. Three major constraints affecting pharmacovigilance talent demand are policy regulations industry development and technological advancement. Constructing the pharmacovigilance talent system faces challenges including regulatory adaptation multidisciplinary integration supply-demand balance and innovation capacity. It is suggested that by strengthening policy guidance and fostering multi-stakeholder collaboration among industry academia education and application to build a high-quality stable pharmacovigilance talent pipeline so as to meet the talent demands for high-quality and innovative development in the pharmaceutical industry and ensure public medication safety.


Key words:  , Pharmacovigilance , New quality productive forces , Talent demand , Innovation , Internationalization

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