Present and Future Aspects of the Japanese Pharmaceutical Affairs Administration

Abstract

The Pharmaceutical Affairs Bureau (PAB) is one of nine within the Ministry of Health and Welfare (MHW). The functions of the PAB include: guidance in testing; examination and research of cosmetics and medical devices; control of poisonous/deleterious substances; control of adulterated/falsely labeled drugs, cosmetics, and medical devices; and control and supervision of activity concerning narcotics and cannabis and their disposal. The organization of the PAB, relationship of the PAB with the National Institute of Hygienic Sciences (NIHS) and National Institute of Health, and a review of the Pharmaceutical Affairs Laws are described. The Pharmaceutical Affairs Laws are developed to regulate drugs, quasidrugs, cosmetics, and medical devices to ensure their quality, efficacy, and safety. Current activities by the PAB concerning international harmonization with the United States and the European Community are explored.