Critical Medicines Lists in Japan and the European Union: Insights into Supply Resilience and Policy Priorities

Abstract

Regulatory authorities are increasingly developing lists of medicines that are at high risk of shortage to strengthen supply chain resilience. This study compares Japan’s Ministry of Health, Labour and Welfare (MHLW) List of Medicines for Stable Supply with the European Medicines Agency (EMA) Union List of Critical Medicines, examining their regulatory roles, selection criteria, and composition using the WHO Anatomical Therapeutic Chemical classification. For antibacterial and antineoplastic agents, we also analyzed mechanisms of action, approval years, and inclusion on the WHO Essential Medicines List. The EMA list primarily includes medicines whose supply interruption would pose an immediate and serious threat to life or essential medical care over a limited period. This narrower scope, with fewer chronic disease medicines, such as antihypertensives and therapies for bone-related diseases and endocrine disorders, reflects strict criteria focused on life-sustaining importance amid economic security risks, including import disruptions. Conversely, the MHLW list is substantially broader. It encompasses not only life-saving medicines but also many chronic disease treatments, whose interruption would have less immediate clinical impact, as well as vitamins, minerals, and diagnostic agents. For antibacterial and antineoplastic agents, both lists include older, well-established medicines, whereas the MHLW-only group contains newer agents reflecting Japanese clinical practice. Although the broad scope of the MHLW list supports routine supply management, it is less suited to rapid prioritization during large-scale shortages driven by external factors. Clarifying risk scenarios and identifying priority medicines may enhance emergency response capacities.