PMDA’s Efforts to Contribute to Ensuring Manufacturing and Quality Control for a Stable Supply of Quality-assured Pharmaceutical Products: Promote Risk Communication Related to the Quality of Pharmaceutical Products

Abstract

 Pharmaceuticals and Medical Devices Agency of Japan (PMDA) has been working with the Ministry of Health, Labour and Welfare (MHLW) and prefectural governments to ensure manufacturing and quality control systems, which is the foundation for a stable supply of quality-assured pharmaceutical products, through GMP inspection and other measures. Recently, PMDA has begun a new initiative to promote risk communication related to pharmaceuticals quality, such as facilitating dialogue between industry side and regulatory side and promoting visualization of pharmaceuticals quality, with the aim of further improving manufacturing and quality control at pharmaceuticals manufacturing facilities. We introduce these initiatives included in the 5th Mid-Term Plan of PMDA, which start in 2024 and their future prospects.