Microphysiological systems (MPS)s with human cells are attracting attentions all over the world as novel pharmacological evaluation systems to improve human predictability of safety, PK/PD, and efficiency of new drugs at the preclinical stage. In 2017, we started AMED-MPS project, the collaborative project among industry, academia, and regulatory, in which we established the MPS prototypes of liver, small intestine, kidney, and blood brain barrier (BBB). However, the technical requirements for respective concepts of use (COU) and regulatory acceptance have not been studied sufficiently. We therefore have started the AMED MPS regulatory science (RS) since 2Q of 2022 as the MPS standardization study. This is the first domestic national project aiming at the development of commercially available MPSs ‘made in Japan’.  For the reference, we will show the ongoing standardization research for BBB MPS. We have established the standard operation procedures (SOP)s to acquire the minimal essential benchmark data that show ‘BBB likeliness’. Lastly we summarized the global trend and the domestic trend in MPS development based on our studies and previous reports.