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

Europe frailty geriatrics medicines approval regulation

Journal

Journal of the American Geriatrics Society
ISSN: 1532-5415
Titre abrégé: J Am Geriatr Soc
Pays: United States
ID NLM: 7503062

Informations de publication

Date de publication:
17 May 2024
Historique:
revised: 27 03 2024
received: 04 01 2024
accepted: 15 04 2024
medline: 17 5 2024
pubmed: 17 5 2024
entrez: 17 5 2024
Statut: aheadofprint

Résumé

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.

Identifiants

pubmed: 38757979
doi: 10.1111/jgs.18953
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 The Authors. Journal of the American Geriatrics Society published by Wiley Periodicals LLC on behalf of The American Geriatrics Society.

Références

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Auteurs

Francesca Cerreta (F)

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

Ewa Balkowiec Iskra (EB)

Experimental and Clinical Pharmacology, Medical University of Warsaw, Warsaw, Mazowieckie, Poland.
Medical Devices and Biocidal Products, The Office for Registration of Medicinal Products, Warsaw, Poland.

Amelia Cupelli (A)

Italian Medicines Agency, Pharmacovigilance, Rome, Italy.

Bruno Sepodes (B)

Universidade de Lisboa Faculdade de Farmácia, Lisbon, Poland.

Elina Rönnemaa (E)

Lakemedelsverket, Uppsala, Sweden.

Mário Miguel Rosa (MM)

Departamento de Neurociências/Laboratório de Farmacologia Clínica E Terapêutica, Universidade de Lisboa, Lisbon, Portugal.

Sabine Mayrhofer (S)

European and International Affairs, BfArM, Bonn, NRW, Germany.

Martine Trauffler (M)

Division of Pharmacy and Medicines, Directorate of Health, Ministry of Health, Luxembourg, Strassen, Luxembourg.

Carla Torre (C)

Universidade de Lisboa Faculdade de Farmácia, Lisbon, Poland.
Faculdade de Farmácia da Universidade de Lisboa, iMedULisboa, Lisbon, Portugal.

Michael Berntgen (M)

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

Katarina Vucic (K)

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

Priya Bahri (P)

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

Armin Koch (A)

Hannover Medical School, Hannover, Niedersachsen, Germany.

Maria Teresa Herdeiro (MT)

Department of Medical Sciences, Institute of Biomedicine (iBiMED), University of Aveiro, Aveiro, Portugal.

Nikica Mirošević Skvrce (N)

HALMED, Zagreb, Croatia.

Julia Pallos (J)

National Institute of Pharmacy and Nutrition, Budapest, Hungary.

Andrea Laslop (A)

Austrian Agency for Health and Food Safety Division Medicines & Medical Devices, Scientific Office, Vienna, Austria.

Classifications MeSH