Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Revised GCP Ordinances Open Ways for Compassionate Use of Medical Devices, Regenerative Medicines
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…
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