Japan’s regulatory advisory committee recommended conditional approvals for two induced pluripotent stem cell (iPSC)‑derived therapies—Amchepry (raguneprocel) and Reheart—under the country’s conditional and time‑limited early approval pathway. If finalized, the decisions would mark the first iPSC‑derived therapies to gain regulatory clearance worldwide. Japan’s framework, designed to accelerate regenerative medicine, has been used selectively since revision of the law more than a decade ago; these endorsements highlight how national regulatory pathways can fast‑track complex cell products while imposing post‑market obligations. The move will be watched closely by developers and regulators globally.