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中国医药导刊 ›› 2025, Vol. 27 ›› Issue (8): 753-759.

• 监管科学 •    下一篇

欧盟老年用药科学监管策略与制度分析

尉海波1，2，3， 杨悦2，3*   

  1. 1.海南大学生物医学工程学院，海南 三亚 572024；

    2.清华大学药学院，北京 100084；

    3.国家药品监督管理局创新药物研究与评价重点实验室，北京 100084
  • 收稿日期:2025-04-21 修回日期:2025-06-03 接受日期:2025-10-10 出版日期:2025-08-28 发布日期:2025-10-13
  • 基金资助:

    药品监管科学全国重点实验室课题（2023SKLDRS0141）

Analysls of Scientific Regulatory Strategles and Systems for Gerlatric Medication in the European Union

WEI Haibo1，2，3， YANG Yue2，3*   

  1. 1.School of Biomedical Engineering， Hainan University， Hainan Sanya 572024， China；
    2.School of Pharmaceutical Sciences，Tsinghua University， Beijing 100084， China；
    3.National Medical Products Administration Key Laboratory for Research and Evaluation of Innovative Drug， Beijing 100084， China
  • Received:2025-04-21 Revised:2025-06-03 Accepted:2025-10-10 Online:2025-08-28 Published:2025-10-13

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摘要：

 随着老年人口比例的不断上升，人口老龄化问题持续加剧，老年人群已日益成为药品使用的核心人群。然而，长期以来该人群在临床试验中的代表性不足，导致用药安全性和有效性数据匮乏，增加了临床决策的不确定性。此外，老年人群的生理异质性、多病共存和多药联用现象加剧了用药管理的复杂性。为应对这些挑战，欧洲药品管理局（EMA）自2011年起实施“老年用药战略”，通过提高临床试验中老年患者的代表性、优化衰弱评估工具、加强剂型适老化设计与药品信息可及性建设，构建完善的风险评估与上市后监测机制，逐步建立了覆盖药品全生命周期的系统性监管框架。本研究系统分析了EMA“老年用药战略”在药物开发、审评及上市后监管方面的应对措施，探讨未来优化老年患者药物可及性和安全性的方向。今后，研究者应结合我国老龄化进程及药品监管现状，借鉴EMA经验，构建适用于中国老年人群的衰弱评估体系，加强对老年人群药品使用的真实世界数据采集与整合；通过制度设计与监管机制的协同发展，构建更加精准、可持续的老年用药监管体系。

  

关键词: 老龄化, 临床试验, 衰弱评估, EMA监管政策

Abstract:

With the proportion of the elderly population steadily rising， population aging has become an increasingly pressing issue. Older adults have emerged as the primary users of pharmaceuticals. However， they have long been underrepresented in clinical trials， resulting in a lack of data on the safety and efficacy of medication and thereby heightening uncertainty in clinical decision-making. Moreover， the physiological heterogeneity among older adults， coupled with the high prevalence of multimorbidity and polypharmacy， further complicates medication management in this demographic.To address these challenges， the European Medicines Agency （EMA） launched the “Geriatric Medicines Strategy” in 2011. This strategy aims to improve the inclusion of older patients in clinical trials， refine frailty assessment tools， promote the development of age-appropriate formulations and better access to medicinal information， and establish a comprehensive framework for risk assessment and post-marketing surveillance. Through these efforts， the EMA has progressively built a systematic regulatory framework that spans the entire life cycle of medicinal products.This paper systematically examines the key regulatory measures introduced under the EMA’s Geriatric Medicines Strategy across the stages of drug development， regulatory review， and post-marketing oversight. It also explores future directions to enhance the accessibility and safety of medicines for older patients. In light of China’s rapidly aging population and current pharmaceutical regulatory landscape， this paper proposes that China can draw on EMA’s experience， such as developing a frailty assessment system tailored to its elderly population and strengthening the collection and integration of real-world data on medication use in older adults， and a more precise and sustainable regulatory system for geriatric medicines should be developed through the coordinated advancement of institutional design and regulatory mechanisms.


Key words: Population aging； , Clinical trials； , Frailty assessment； , EMA regulatory policy

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