Risk to the Stable Supply of Pharmaceuticals Due to Supply Chain Disruptions

「This fiscal year, we selected “damage caused by cyberattacks” and “supply chain management (stable supply).”」

「We also conduct quality audits of our own plants and contractors and regularly confirm that they are being properly operated. In this way, we maintain consistently high standards of quality control to prevent products that do not conform to specifications from being shipped.」

「To address the risk of non-compliance with the Pharmaceuticals and Medical Devices Act, we have established strict internal quality standards and thoroughly conduct production-record documentation and review, change control and deviation management. We also conduct quality audits of our own plants and contractors and regularly confirm that these controls are being properly operated.」

「Our Group has identified the stable supply of products as a materiality and established a framework to address the risks of natural disasters and accidents and the risk of non-compliance with the Pharmaceuticals and Medical Devices Act. Omitted. However, if natural disasters such as earthquakes and typhoons, the spread of pandemics including COVID-19, fires, incidents such as system failures and terrorism, or non-compliance with the Pharmaceuticals and Medical Devices Act cause the functions of specific plants or external contractors, or the supply of raw materials from business partners, to stop, resulting in a stagnation or delay in production activities, our Group’s operating results and financial position may be affected.」