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Japan Progresses 'Urgent Approval' System To Speed Drug Access

Tighter Monitoring Would Be Required

Executive Summary

Japan is intending to revise existing pharma legislation to enable the urgent approval of new drugs with "assumed efficacy", with a maximum three-year period for confirmation, in cases of emergency need. The government will also ask companies to implement tighter safety monitoring and management of supply chains, with swift data disclosure required, as part of the planned changes.

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