OBJECTIVES: Both Japan and the EU have accelerated regulatory pathways for regenerative medicines (RMs) and advanced therapy medicinal products (ATMPs). However, these therapies face stark market access challenges given high upfront costs and uncertain long-term efficacy and safety. Therefore, accelerated approval may not lead to successful market access. We aim to determine concordance between licensing and reimbursement in Japan and major EU markets (UK, Germany, France) and to identify HTA methods or funding models beyond those for conventional pharmaceuticals or devices. METHODS: Secondary research was conducted to review the licensing and reimbursement status of RMs and ATMPs in Japan and EU markets and to identify any specific HTA considerations or funding models. RESULTS: Japan has four licensed RMs which are automatically reimbursed. EU markets are very heterogeneous. Nine ATMPs received EMA authorization, four of which were later revoked. NICE recommends five ATMPs for NHS funding. HAS recommends only one ATMP, generally citing insufficient actual benefit. In Germany, nine ATMPs received hospital exemptions and reimbursement outside EMA approval. No literature was identified describing evaluation methods or funding models for RMs in Japan beyond existing regulatory/public insurance pathways. In contrast, European literature investigated the suitability of existing HTA methods and alternative funding models for ATMPs, including annuity payments and risk-sharing agreements. CONCLUSIONS: EU markets demonstrate clear separation between licensing and reimbursement, indicating an uncertain path to reimbursement and stricter evidentiary requirements. There is commensurately more active consideration of evaluation methods and funding models. In contrast, licensing reliably leads to reimbursement in Japan’s unique system where conditional time-limited licensing based on phase 1/2 data has proven attractive to biotech companies. There are no evaluation or funding considerations aside from existing biennial price reviews. Given the infancy of Japanese regenerative medicine legislation, long-term implications remain to be seen and the world will be watching.