EMA Reflection paper on the pharmaceutical development of medicines for use in the older population
According to Eurostat, the older population in the European Union is expected to grow from around 84 million in 2008 to approximately 141 million by 2050. The very elderly constitute the fastest growing subset. Older people differ from children and adults of younger or middle age with respect to an increased prevalence of gradually declining human organ and body functions, resulting in physical, physiological and/or cognitive impairments, multi- and co-morbidities, and/or frailty. As any such impairments may start at a different chronological age, occur in different orders, and worsen in different rates, older people of the same chronological age can be quite different (e.g. healthy, facing some minor impairments only, frail). In general, older people are the majority users of many medicines and at highest risk of encountering practical medication (usability) problems, which may increase the risk for poor adherence, medication errors and/or reduced patient or caregiver quality of life. Considering the above, it is essential that the needs of older (and especially frail) people are duly considered in the pharmaceutical development of medicines that may be used in the older population.
This reflection paper is intended to communicate the current status of discussions on the pharmaceutical development of medicines that may be used in the older population, and to invite comments on the topics addressed. The paper is not intended to provide regulatory or scientific guidance, although it may contribute to any such development in the future. It is expected that the paper will be read in conjunction with the existing directives, regulations, European Commission, ICH, CHMP and EMA guidelines, Q&A documents and other documents of relevance as linked to or published on the EMA website (www.ema.eu). The examples in this paper should neither be understood as an exhaustive list nor as the only possible options to address a specific topic.
The reflections apply to any new application for a marketing authorization (MA) or variation to an existing MA, and for all application types including full and abridged MAs (i.e. new medicinal products, generics, well established use). Where appropriate, the reflections may be considered during the clinical trial phases and in the post-authorization phase as part of the product lifecycle management. They may also be of relevance to other age groups suffering from similar impairments and/or needs (e.g. an easy to open packaging is relevant for rheumatic patients of any age). They need to be considered in a patient centric approach to pharmaceutical development.
