Pharmaceutical development of medicines for use in the older population - Scientific guideline

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.

Medicines developers are encouraged to take a patient-centric approach to pharmaceutical development, i.e. to design medicines that take into account the disease, disease setting and the needs of patients, including older people with co-morbidities and polypharmacy.

Update: EMA invites users of this reflection paper to provide feedback on their experiences applying its principles by emailing [e-mail].  Feedback will support the progress of scientific and regulatory knowledge in the development of medicines for older people and patient-centric medicines.

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

Keywords: Pharmaceutical development, older people, elderly, ageing, frailty, age-appropriateness, medication management, medication errors, off-label, usability

Current version

Reflection paper on the pharmaceutical development of medicines for use in the older population - First version

AdoptedLegal effective date: 01/05/2021Reference Number: EMA/CHMP/QWP/292439/2017

Document history - First version

Reflection paper on the pharmaceutical development of medicines for use in the older population - First version

AdoptedLegal effective date: 01/05/2021Reference Number: EMA/CHMP/QWP/292439/2017

Draft reflection paper on the pharmaceutical development of medicines for use in the older population - First version

Consultation dates: 01/08/2017 to 31/01/2018Draft: consultation closedReference Number: EMA/CHMP/QWP/292439/2017Summary:

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.

Concept paper on the need for a reflection paper on quality aspects of medicines for older people - First version

Consultation dates: 05/04/2013 to 30/06/2013Draft: consultation closedReference Number: EMA/165974/2013Summary:

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 European Medicines Agency recognises that it should ensure that the specific needs of the elderly are integrated during the development, approval and use of medicines.