Pharmaceutical development of medicines for use in the older population

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Reflection paper

Deadline for comments: 31/01/2018

Reference numberEMA/CHMP/QWP/292439/2017
KeywordsPharmaceutical development, older people, elderly, ageing, frailty, age-appropriateness, medication management, medication errors, off-label, usability

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. The CHMP may develop this reflection paper into regulatory or scientific guidance. 

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Document history

First version

In progress


Reflection paper



Concept paper

Published: 01/08/2017

Deadline for comments: 31/01/2018 


Published: 05/04/2013

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