Pharmaceutical development of medicines for use in the older population - Scientific guideline
Table of contents
The reflection paper describes aspects that medicines developers may consider when designing medicines for older people, such as selecting appropriate routes of administration and dosage forms, dosing frequency, excipients, container closure systems, devices and technologies, and user instructions in the product information.
Medicines developers are encouraged to take a patient-centric approach to pharmaceutical development, i.e. to design medicines that take into account the disease, disease setting and the needs of patients, including older people with co-morbidities and polypharmacy.
Update: EMA invites users of this reflection paper to provide feedback on their experiences applying its principles by emailing email@example.com.
Feedback will support the progress of scientific and regulatory knowledge in the development of medicines for older people and patient-centric medicines.
The CHMP may develop this reflection paper into regulatory or scientific guidance.
Keywords: Pharmaceutical development, older people, elderly, ageing, frailty, age-appropriateness, medication management, medication errors, off-label, usability
Reflection paper on the pharmaceutical development of medicines for use in the older population - First version (PDF/391.68 KB)Adopted
First published: 22/10/2020
Legal effective date: 01/05/2021
Draft reflection paper on the pharmaceutical development of medicines for use in the older population - First version (PDF/235.6 KB)Draft: consultation closed
First published: 01/08/2017
Last updated: 01/08/2017
Consultation dates: 01/08/2017 to 31/01/2018
Concept paper on the need for a reflection paper on quality aspects of medicines for older people - First version (PDF/80.39 KB)Draft: consultation closed
First published: 05/04/2013
Last updated: 05/04/2013
Consultation dates: 05/04/2013 to 30/06/2013