Through the rapid progress in stem cell technology and in engineering technologies such as microfluidic devices and microfabrication, research and development of a new cultured human tissue/organ model, "micro-physiological system" (MPS), has been active. MPS can realize physiological environment better than conventional two-dimensional static culture. Worldwide, MPS World Summit series had begun toward the establishment the international MPS society, where intimate cooperation among developers, uses and regulation authorities is focused. In Japan, the development of promising devices has progressed mainly through the AMED-MPS project. By fully utilizing these advanced technologies, it will be no longer a dream to realize in vivo-like tissues in vitro. With such academic achievements, it is also important to develop MPS satisfying Context of Use (CoU) in various applications in industries and society. These two progresses should be in parallel toward full utilization of in vitro or non-animal testing. This also meets the demand from the society to realize 3Rs concept in animal experiments. In the mid- to long-term, it is expected to develop into a new methodology for the evaluation of human body responses, in which the response of MPS is analyzed by multi-omics, and the biological response is described and predicted through the construction and extended use of a multi-scale mathematical model.