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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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Japan 2010s In Review: Specialize, Focus, Innovate

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.

Japan 2010s In Review: Specialize, Focus, Innovate

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.

New Japan PMDA Head Brings Strong Clinical, Patient Focus To Role

The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.

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