Japan’s regulatory advisory body recommended conditional, time‑limited approvals for two iPSC‑derived therapies: Amchepry (raguneprocel) and Reheart, positioning them to become the first iPSC medicines to receive market clearance. The recommendations were made under Japan’s conditional early approval (CEA) pathway, which was designed to accelerate regenerative medicine products after earlier legislative reforms. The endorsements follow years of clinical development and reflect Japan’s continued willingness to take regulatory risks to foster advanced cell therapies. Sponsors will now work through final regulatory steps and post‑approval data commitments required under the conditionally‑approved model.