REGULATORY
    Pharma Groups Press for Freeze on CEA Price Cuts, Cite Unresolved Issues
    By Ken Yoshino September 17, 2026
    Three major pharmaceutical trade groups on September 16 called for a temporary freeze on price adjustments under Japan’s cost-effectiveness assessment (CEA) system, arguing that key technical issues remain unresolved.The Japan Pharmaceutical Manufacturers Association (JPMA), the…

    LATEST

    Ueno Retained as Health Minister in Takaichi Cabinet Reshuffle
    September 17, 2026
    Kenichiro Ueno will remain as Japan’s health, labor and welfare minister in Prime Minister Sanae Takaichi’s reshuffled Cabinet, according to a roster announced by Chief Cabinet Secretary Minoru Kihara on September 17.Finance Minister Satsuki Katayama…
    Japan Approves Keytruda, Leqembi SC Formulations, Xcopri, and More Drugs
    September 17, 2026
    Japan’s health ministry on September 16 granted regulatory approvals for a slew of new medicines and indications, including subcutaneous formulations of MSD’s Keytruda (pembrolizumab) and Eisai’s Leqembi (lecanemab).MSD’s SC product Keyject, known as Keytruda Qlex…
    Japan Finalizes Framework for OTC-Like Drug Charge Ahead of March Rollout
    September 17, 2026
    A key health ministry panel on September 16 endorsed the final framework for Japan’s upcoming additional charge on “OTC-like” prescription medicines, locking in exemptions for certain patients and treatments ahead of its March 2027 rollout.The…

    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

    Regional Formularies Gain Ground, Raising Stakes for Drug Makers, Wholesalers
    By Tatsuya Otsuka

    Japan is ramping up its push to spread regional formularies nationwide, a policy expected to standardize treatments, strengthen supply resilience,…

    COLUMN

    The One Mistake on Your Resume
    By Philip Carrigan

    We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…

    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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