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老龄化人口的医药需求:EMA 的观点与政策。

Medicines for an aging population: The EMA perspective and policies.

机构信息

European Medicines Agency, Amsterdam, Noord-Holland, Netherlands.

Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Mazowieckie, Poland.

出版信息

J Am Geriatr Soc. 2024 Sep;72(9):2921-2927. doi: 10.1111/jgs.18953. Epub 2024 May 17.

Abstract

The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre- and post-approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment.

摘要

欧洲药品管理局在十多年前通过了他们的老年医学药物策略。该策略旨在阐明将在老年人群中使用的新药的营销授权的证据基础,并确保向患者和医疗保健提供者适当传达研究结果。在过去的十年中,出现了新的工具和数据源来支持该策略目标,应该考虑使用它们。提出了可能的具体行动来改进临床试验的设计、批准前和批准后的数据收集、评估研究结果以及沟通,以协助制定知情处方和安全用药。应该从满足患者需求的角度来实施和优先考虑这些行动,同时最大限度地有效利用资源,旨在将老年医学方面纳入常规药物开发和评估。

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