Ministry of Health, Labour and Welfare ( MHLW , Japan)

Abstract

Abstract The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law (PAL) and related ordinances. The Ministry of Health, Labour and Welfare (MHLW) is the governmental body responsible for enacting legislation for pharmaceutical affairs. The MHLW makes final decisions on whether it should halt trials for which investigational new drugs notifications (INDs) are submitted, and whether it should approve drugs for which New Drug Applications (NDAs) are submitted. The Pharmaceuticals and Medical Devices Agency (PMDA) is a semi‐governmental agency established by law that conducts scientific review of INDs and NDAs via internal review teams. The role of the PMDA as a review agency has become critical in pharmaceutical research and development activities, with recent progress in global regulatory harmonization and the necessity for cooperation between the regulator and the industry. The The PMDA also provides consultation services for clinical development, similar to those by the U.S. Food and Drug Administration. Historically, Japanese regulations have evolved by gradually accepting Western regulatory components into preexisting ones. Although most basic regulatory structures are similar to those in Western countries, there are still some obvious differences, including the applicability of INDs. Facing the recent decline in the numbers of domestic trials, the MHLW has issued several measures to promote domestic trials, including grants to train hospital staffs, but it is not expected that the decline will reverse easily because it is related to a diminishing demand for Japanese trials in response to the globalization of pharmaceutical research and development.