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Japan's regenerative medicine sector has encountered major challenges, underscored by the recent failures of products such as HeartSheet and Collategene. These setbacks expose critical weaknesses in the fast-track approval system, raising concerns about patient safety and the scientific robustness of product evaluations. Despite strong governmental support, addressing these fundamental issues is essential for the future success of regenerative medicine in Japan.
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Hiroshi Kawaguchi (2025) studied this question.
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