REGULATORY

PFSB Issues Notification on Reporting of Malfunctions of Regenerative Medicine Products

October 14, 2014
The Pharmaceutical and Food Safety Bureau (PFSB) of the Ministry of Health, Labor and Welfare (MHLW) issued a director-general notification on October 2 to prefectures regarding ADR reporting (malfunction reporting) for drug/device combination products (drugs manufactured and marketed with devices…

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REGULATORY

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