Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
Nitrosamines Found in Duloxetine, Diltiazem; Panel Sets Intake Limits
A safety panel of Japan’s Ministry of Health, Labor and Welfare (MHLW) on April 24 set the acceptable intake limits after nitrosamines were detected in some products containing duloxetine HCl and diltiazem HCl. The detections were made during self-inspections conducted…
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REGULATORY
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The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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