REGULATORY

Revised GCP Ordinances Open Ways for Compassionate Use of Medical Devices, Regenerative Medicines

July 25, 2016

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The Ministry of Health, Labor and Welfare (MHLW) promulgated revised GCP ordinances for medical devices and regenerative medicine products on July 21, opening the door for the implementation of a Japanese version of compassionate use, dubbed humanitarian trials or expanded…

To read the full story

MHLW Revises GCP Ordinance to Incorporate New Compassionate Use Scheme
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