The 146th Annual Meeting of the Pharmaceutical Society of Japan (Osaka)

Organizer: Daiju Yamazaki (Nat. Inst. of Health Sci.), Seiichi Ishida (Sojo Univ.)

In 2025, American and European regulatory authorities successively declared their withdrawal from animal testing for non-clinical trials in drug discovery, beginning to shift their focus toward human-like in vitro testing methods. Among these human-like in vitro testing methods, one technology gaining significant attention is microphysiological systems (MPS). Cell culture using MPS enables highly accurate in vitro simulation of human organ function. Globally, there is now vigorous activity to apply this technology to drug discovery and other fields. In Japan, the AMED "Project Focused on Developing Key Evaluation Technology: Development of Platform Technology for Drug Discovery through Application of Regenerative Medicine" conducted development of MPS devices and their loaded cells (Phase 1: 2017–2021). Currently, development of evaluation methods using MPS (Phase 2: 2022–2026) is underway. Furthermore, under AMED "Research on Regulatory Science of Pharmaceuticals and Medical Devices" (2025–2027), parallel to developing evaluation methods for incorporating MPS into OECD test guidelines, inter-laboratory validation studies have been started domestically. Discussions among relevant stakeholders regarding qualification in drug discovery have also begun, advancing the regulatory acceptance of MPS. Against this backdrop, this symposium aims to organize the current status of MPS utilization across various fields and the discussions within each field, and then deliberate on the next necessary steps.