As part of a larger reorganization and reform effort, in January 2001 Japan’s Ministry of Health and Welfare and Ministry of Labor merged, creating the Ministry of Health, Labor, and Welfare (MHLW). Among other things, the agency’s mandate includes the promotion of social welfare, social security, public health, and the betterment of working conditions for laborers. However, from the standpoint of medical device and pharmaceutical firms, the agency’s most important role is regulating medical devices and pharmaceuticals in Japan.
Within the MHLW, the Pharmaceutical and Medical Safety Bureau (PMSB) is primarily responsible for clinical studies, approvals and licensing, and post-marketing safety. The Evaluation and Licensing Division of PMSB examines and evaluates drugs and medical devices, issues manufacturing and import licenses and approvals for pharmaceuticals and devices, rules on issues related to the Japanese Pharmacopoeia, and designates orphan drugs and orphan medical devices. The Safety Division of PMSB reviews the safety of medical products and is responsible for planning and drafting policies to ensure the safety of drugs, quasi-drugs, cosmetics, and medical equipment and devices.
Other important MHLW divisions or related organizations for medical device and pharmaceutical firms include the Health Policy Bureau and the Pharmaceuticals and Medical Devices Evaluation Center. The Health Policy Bureau (HPB) is the division of MHLW responsible for enforcement of laws concerning the production and distribution of medical products. HPB also has a role in representing companies’ interests with respect to the drug pricing system and reimbursement. The Pharmaceutical and Medical Devices Evaluation Center is part of the National Institute of Health Sciences (an organization that works closely with, but remains administratively separate from, the MHLW). The Evaluation Center scientifically reviews medical products, conducting reviews ranging from clinical studies to approval reviews, as well as post-marketing assessments.