Medicines for an aging population: The EMA perspective and policies

Francesca Cerreta, Ewa Balkowiec Iskra,Amelia Cupelli,Bruno Sepodes, Elina Ronnemaa,Mario Miguel Rosa, Sabine Mayrhofer, Martine Trauffler,Carla Torre,Michael Berntgen,Katarina Vucic, Priya Bahri,Armin Koch,Maria Teresa Herdeiro, Nikica Mirosevic Skvrce, Julia Pallos,Andrea Laslop

JOURNAL OF THE AMERICAN GERIATRICS SOCIETY(2024)

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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.
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Key words
Europe,frailty,geriatrics,medicines approval,regulation
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