Precision medicine in mental health: applications, challenges, and recommendations.

Mental disorders represent a major and growing public health challenge in Europe and worldwide, characterised by marked clinical, biological, and functional heterogeneity, that limits the effectiveness of current diagnostic and therapeutic approaches. In recent years, advances in precision medicine have initiated a paradigm shift in psychiatry, offering new opportunities to improve prevention, prediction, diagnosis, treatment selection, and long-term management by integrating biological, psychological, social, and environmental information.This EPA Guidance Paper provides an overview of the current state of precision medicine in mental health and outlines its potential clinical, scientific, and policy implications. We review key advances in genomics, epigenetics, neuroimaging, transcriptomics, digital technologies, and artificial intelligence, highlighting their relevance across the full clinical pathway, from risk prediction and early detection to treatment personalisation and monitoring. We also examine major barriers to implementation, including limited biomarker validation, insufficient representativeness of research populations, ethical and regulatory challenges, data protection concerns, and inequalities in access across healthcare systems.Based on the available evidence, we propose strategic recommendations to support the responsible and equitable integration of precision approaches into mental health care in Europe. These include strengthening translational research, promoting multidisciplinary collaboration, updating regulatory and ethical frameworks, enhancing professional training, and prioritising mental health within national and European research and health agendas. By addressing these challenges, precision psychiatry has the potential to contribute to more effective, person-centred, and sustainable mental health care, while supporting innovation, reducing stigma, and improving outcomes for patients and society.