REGULATORY
    CEA Expansion Could Make Drug Price Premiums a Liability: JPMA Official
    By Ken Yoshino October 16, 2026
    Japan’s proposed expansion of price cuts under its cost-effectiveness assessment (CEA) system could create a paradox that makes drug makers better off not receiving innovation-related price premiums, a senior pharmaceutical industry official warned.Naoya Fujihara, chair…

    LATEST

    M3’s MR-kun Hit by Data Breach, Pharma Staff and Doctors Exposed
    October 16, 2026
    M3 said on October 15 that personal information belonging to some pharmaceutical company employees and physician members was leaked following unauthorized access to its “MR-kun” service, an online platform that enables drug reps to provide…
    Santen Hits 93% Weekly AI Adoption in R&D, Digitizes Truckload of Research Records
    October 16, 2026
    Generative artificial intelligence is becoming an integral part of daily operations at Santen Pharmaceutical, with a weekly AI utilization rate at its R&D division reaching 93%.Santen is using generative AI to help prepare study protocols…
    Nipro’s Stemirac Nears 1st Full Nod Conversion for Regenerative Therapy
    October 16, 2026
    A Japanese health ministry panel on October 15 endorsed the full approval of Nipro’s Stemirac, a stem cell therapy for spinal cord injuries. The product is now poised to become Japan’s first regenerative medicine product…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Romiplate to See Steepest Cut in April Market Expansion Re-Pricing

    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

    COMMENTARY

    Japan Moves to Break Plasma Product Capacity Crunch with Factory Aid
    By Takashi Ebisawa

    Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…

    COLUMN

    Outside the Bubble: Lunch with Pharma Delegates
    By Philip Carrigan

    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…

    Drug Approval & Reimbursement in 2025

    Chuikyo OKs Listing of Novartis’ Pluvicto, Peak Sales Outlook at 42.1 Billion Yen

    Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

    Chuikyo Debate on Off-Year Drug Price Revisions

    MHLW Unveils New List Prices for FY2025 Revision; Stelara, Januvia Hit by PMP Return
    By Ken Yoshino

    The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

    Discussions on Next PMD Act Amendment

    Japan Cabinet Approves Bill to Amend PMD Act

    The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

    Drug Approval & Reimbursement in 2024

    Japan Approves Zepbound, Qalsody, and Lots More Drugs

    Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…

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