Unlike the paediatric case (regulation (EC) No 1901/2006), there is no specific legal requirement for the development of medicines for geriatric use. Nevertheless, there is a need to ensure that medicines are fit for use by patients of all ages within the indicated patient populations. Given the growing older population, the Agency recognizes that it should ensure that the specific needs of the elderly are integrated during the development, approval and use of medicines.

 

Download document Concept paper on the need for a reflection paper on quality aspects of medicines for older people
Reference number EMA/165974/2013
Status draft: consultation open
First published 05/04/2013
Last updated 05/04/2013
Consultation start date 05/04/2013
Consultation end date 30/06/2013
Email address for submissions qwp@ema.europa.eu

 

Posted on the EMA website on 5 April 2013