Older people are the fastest growing population group in Europe and are the main users of medicines.
Various initiatives are in place at EMA to ensure that the development, evaluation and safety monitoring of medicines take into account the unique considerations associated with older patients.
For more information, see:
EMA's geriatric medicines strategy sets out its vision to better address the needs of older people in the development and evaluation of medicines, by building on its existing activities:
The strategy aims to:
EMA published the strategy in 2011.
CHMP outlines in its yearly work plan the objectives to be addressed in a given year. PRAC and the Scientific Advice Working Party act as sponsors of the geriatric topic.
Geriatric experts able to advise EMA's committees on aspects related to medicines for older people feature on EMA's public list of European experts:
EMA renewed its pool of experts in 2023 via a dedicated call for clinicians, experts and patient representatives specialised in geriatrics.
EMA will call on selected experts to provide supplementary expertise when needed.
This expertise includes independent scientific or technical recommendations related to medicines under evaluation and support to develop position papers or guidance documents.
Scientific guidelines are available to help medicine developers address the specific requirements of older people in their medicine development programmes, including in the design and conduct of clinical trials:
In addition, EMA encourages medicine developers to address questions on developing medicines for use in the older population as part of scientific advice or in portfolio and technology meetings.
EMA also aims to ensure that all of its scientific guidelines relevant for older patient populations consider the needs of those patients. In 2013, EMA published an analysis of the number of scientific guidelines that it reviewed and provided comments on to reflect the geriatric population between 2011 and 2013:
In 2006, EMA published a report on the extent to which CHMP guidelines and clinical trials supporting marketing authorisations address the needs of older people. This found adequate compliance with international requirements and made recommendations on how to improve the implementation of existing guidelines and update guidelines on the design and conduct of clinical trials:
EMA's CHMP has revised its assessment templates and guidance to assessors to improve clarity of geriatrics-specific issues. This aimed to improve product information and enable informed prescription. It should help:
CHMP first updated the assessment template with clearer information on the number of elderly people involved in a medicine's clinical-trial programme and side effects in older patients in 2011.
It ran a pilot on a dedicated geriatric section in the Day 80 and Day 210 assessment templates with ten new medicines between May 2016 and March 2018. CHMP will decide on inclusion of updates in the standard templates following an assessment of the pilot.
EMA has also prepared training on how to reflect information targeted at older patients in the summary of products characteristics:
In 2013, EMA published an analysis on how appropriately product information reflected data on the geriatric population in marketing authorisation applications submitted between 2011 and 2013:
When evaluating marketing authorisation applications, EMA's CHMP considers if specific activities concerning aspects such as comorbidities and the monitoring of specific side effects associated with older patients should be included in the risk management plan or as post-authorisation measures.
EMA is also carrying out pilot studies via its Darwin EU coordination centre which provides evidence on the use, safety and effectiveness of human medicines. These studies investigate the use of medicines in the older population, with a focus on frailty and comorbidity aspects.
The studies are in line with the CHMP work plan.
For more information, see:
EMA engages with regulatory authorities, pharmaceutical companies and organisations representing the interests of elderly people in Europe and beyond.
It also organises workshops which address the needs of older populations in medicine development and use.
See upcoming and past EMA events related to geriatrics in our Events section. You can search for them under filter options by using keywords such as 'older people' and 'geriatrics':
Geriatricians are also represented in the Healthcare Professionals’ Working Party. This allows EMA to gain a better understanding of how:
EMA and collaborating experts also publish articles on geriatric topics in scientific journals.