EMA: Concept paper on the need for a reflection paper on quality aspects of medicines for older people

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.