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PMDA Chief Defends Japan Spinal Cord Therapy Approval

Executive Summary

The head of Japan’s drug and device regulator has defended and supported the country’s recent world-first decision to grant approval to a novel cell-based therapy for spinal cord injuries, saying that patient considerations came first.

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Reimbursement issues continued to dominate the policy sphere in Japan during the last decade, while new forms of therapy benefited from positive regulatory reforms. Meanwhile, consolidation and specialization were major threads running through the corporate sector.

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Corporate consolidation and specialization were major threads running through the 2010s in Japan. Reimbursement pricing issues continued to dominate the policy sphere while new forms of therapy benefited from positive regulatory reforms.

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