Japan’s regulatory advisory body recommended conditional early approvals for Amchepry (raguneprocel) and Reheart, positioning them to become the world’s first iPSC‑derived therapies to receive regulatory clearance under Japan’s conditional and time‑limited early approval pathway. The Pharmaceutical Affairs and Food Sanitation Council’s regenerative medicine subcommittee endorsed the products after deliberations, reflecting Japan’s long‑standing accelerated pathway for cell and gene therapies. Conditional approvals grant time‑limited market access while requiring post‑approval evidence generation to confirm benefit and safety.