2021 Volume 11 Issue 1 Pages 53-61
In addition to the environment surrounding of the pharma industries (1) declining the productivity in research and development in pharma industries, (2) widespreadness of 3Rs in animal testing, and (3) emergence of new modalities, new approach methodologies (NAMs) are actively incorporated to benefit the patients by transformation of the cutting-edge science based on the concept of regulatory authorities. The microphysiological system (MPS) is expected as one of the candidates in NAMs. MPS generally refers to an in vitro culture system in which a culture environment close to that of a living body (in vivo) is reconstructed in a created minute space using a microfluidic device. Currently, many products have been put into practical use by US’s and Europe’s companies and are sold all over the world. This time, I would like to introduce the trends of research & development for MPS in global scale, the trends in the pharmaceutical industry regarding MPS in each region, and the status of global competition in regulatory science over MPS. I hope that this information will be an opportunity to start strategic discussions for regulatory science to quickly expand the utilization of the cutting-edge science for the value of patients and to think about the additional role of researchers in pharma industries.
