Medicines for an aging population: The EMA perspective and policies

Author:

Cerreta Francesca1ORCID,Iskra Ewa Balkowiec23,Cupelli Amelia4,Sepodes Bruno5ORCID,Rönnemaa Elina6,Rosa Mário Miguel7ORCID,Mayrhofer Sabine8,Trauffler Martine9,Torre Carla510ORCID,Berntgen Michael1,Vucic Katarina1,Bahri Priya1,Koch Armin11,Herdeiro Maria Teresa12,Mirošević Skvrce Nikica13,Pallos Julia14,Laslop Andrea15

Affiliation:

1. European Medicines Agency Amsterdam Noord‐Holland Netherlands

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

3. Medical Devices and Biocidal Products The Office for Registration of Medicinal Products Warsaw Poland

4. Italian Medicines Agency, Pharmacovigilance Rome Italy

5. Faculdade de Farmácia, Universidade de Lisboa Lisbon Portugal

6. Lakemedelsverket Uppsala Sweden

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

8. European and International Affairs BfArM Bonn NRW Germany

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

10. Faculdade de Farmácia da Universidade de Lisboa iMedULisboa Lisbon Portugal

11. Hannover Medical School Hannover Niedersachsen Germany

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

13. HALMED Zagreb Croatia

14. National Institute of Pharmacy and Nutrition Budapest Hungary

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

Abstract

AbstractThe 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.

Publisher

Wiley

Reference18 articles.

1. Eurostat.Population Structure and Ageing.2023. Accessed May 15 2024.https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Population_structure_and_ageing

2. ICH. ICH E7.Studies in Support of Special Populations: Geriatrics: Questions and Answers.2009. Accessed May 15 2024.https://www.ema.europa.eu/en/ich‐e7‐studies‐support‐special‐populations‐geriatrics‐questions‐and‐answers‐scientific‐guideline

3. Drug Policy for an Aging Population — The European Medicines Agency's Geriatric Medicines Strategy

4. Medicines for older people: assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal products

5. Regulatory considerations on the enrollment of older adults in oncology clinical trials

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