REGULATORY

MHLW Revises Q&A on Nitrosamine Self-Inspections, OKs Use of Interim Control Limit

June 5, 2025

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The Ministry of Health, Labor and Welfare (MHLW) has issued an administrative communication that partially revises its Q&A on self-inspections conducted by drug manufacturers regarding the risks of nitrosamine impurities in their products. When nitrosamines exceeding acceptable levels are detected,…

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Chuikyo Debate on FY2026 Drug Pricing Reform

Chuikyo Backs Draft FY2026 Pricing Reform Outline, Rejects Key Industry Requests

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COLUMN

AI: Your New HR BFF (Not Your Replacement!)

By Philip Carrigan

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COMMENTARY

Radioligand Therapy Faces Capacity Bottleneck in Japan, System Build-Out Needed to Deliver on Promise

By Koji Shimomura

Novartis’ Pluvicto (lutetium vipivotide tetraxetan (177Lu)) won reimbursement listing in Japan in November as a radioligand therapy (RLT) for PSMA-positive…