Current status of global harmonization of GMP standards in PIC/S and future prospects of effective GMP inspection by PMDA

Abstract

The author has been involved in the management of PIC/S since January 2022 as Executive Bureau Member. The current status of global harmonization of GMP standards, the challenges facing PIC/S and the significance of participating in PIC/S activities are described in this review article with the author's personal views. PMDA, Ministry of Health, Labour and Welfare (MHLW) and 47 prefectures of Japan became PIC/S' Participating Authority in 2014. To ensure the quality of medicines distributed on the global market, PIC/S including the PMDA should try to develop more effective GMP regulations.