Regulatory development of geriatric medicines: To GIP or not to GIP?

•There is lack of knowledge on the benefit/risk ratio of medicines in the elderly.•Current regulatory status on the development of geriatric medicines is poor.•The different stakeholders should be involved.•Challenges in the regulatory development of geriatric medicines are multiple.

Geriatric patients represent the main users of medicines, but are historically often minimally included in clinical trials, resulting in a gap in the knowledge of the benefit/risk balance of medicines in this heterogeneous population. As the worldwide population is aging, the need for safe and effective medicines for older patients is proportionally increasing. The aim of this review is to provide an overview of the current regulatory status of the development of geriatric medicines, the encountered challenges and the view of the involved stakeholders, coming to the conclusion whether it is necessary or not to implement a Geriatric Investigation Plan (GIP), by analogy with pediatrics.

Graphical abstractFigure optionsDownload full-size imageDownload as PowerPoint slide