Pharmaceuticals and Medical Devices Agency (PMDA)

What is the PMDA? The Pharmaceuticals and Medical Devices Agency (PMDA) is an independent administrative institution under Japan’s Ministry of Health, Labour and Welfare (MHLW), established in April 2004. It functions as Japan’s central authority for the scientific evaluation and safety oversight of pharmaceuticals, medical devices, regenerative medicines, and related health products. The PMDA operates with a mandate similar to agencies such as the U.S. FDA or the UK’s MHRA, with a specialized focus on rigorous scientific review and post-market surveillance. What does the PMDA do? The PMDA oversees a broad set of functions aimed at ensuring that medical products in Japan meet stringent standards for safety, efficacy, and quality. Its responsibilities include the scientific review of new drug and device applications, assessments of Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and laboratory compliance (GLP/GPSP), and inspections of manufacturing facilities. It also administers robust post-market safety surveillance systems—collecting, analyzing, and disseminating safety data—and provides one-stop consultation services to support applicant navigation. Uniquely, the PMDA administers relief and compensation services for individuals who suffer adverse health effects from regulated products.