In Japan, post-approval execution of post marketing surveillance (PMS) is requested by the
Japanese Pharmaceutical Affairs Law (J-PAL) in order to accumulate safety and efficacy data
for reexamination. Reexamination period is defined by J-PAL. Eight years after approval of a
new substance, results of PMS need to be submitted as a part of reexamination dossier to the
Japanese regulatory authority, the Ministry of Health, Labour and Welfare (MHLW).