Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Allow Use of OOS Autologous Cell Products via PMD Act Amendment: FIRM
Japan’s regenerative medicines association on May 16 called for amending the Pharmaceuticals and Medical Devices (PMD) Act to allow for the use of autologous cell-processed products made for therapeutic purposes even when they are out of specification or OOS. The…
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