REGULATORY
    Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
    By Kohei Hori October 29, 2026
    Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations under Japan’s cost-effectiveness assessment (CEA) system, although some stressed the need to safeguard the independence…

    LATEST

    Kissei Cuts H1 Profit Outlook on Tavneos Approval Revocation Risk
    October 29, 2026
    Kissei Pharmaceutical said on October 29 that it will book extraordinary losses related to its vasculitis drug Tavneos (avacopan), as Japanese regulators pursue administrative proceedings that could lead to the revocation of the product’s marketing…
    FY2027 Revision: HCPs Press for Action on Drug Shortages, Negative Margins
    October 29, 2026
    Stable drug supplies emerged as a key issue in Japan’s FY2027 off-year drug price revision debate on October 28, with healthcare providers calling for effective measures to address persistent shortages and negative margins in pharmaceutical…
    Zolgensma Cost-Effectiveness Analysis to Resume after Five-Year Halt
    October 29, 2026
    Japan will resume a cost-effectiveness assessment (CEA) of Novartis Pharma’s spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec), following a five-year suspension to collect long-term efficacy data.The Central Social Insurance Medical Council (Chuikyo) approved…

    COMMENTARY

    Alzheimer’s Pipeline Looks Past Amyloid to Earlier Intervention, Tau Targets
    By Hayate Horiguchi

    The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…

    COLUMN

    New York Note - 1: JETRO’s Role in Connecting Japan with the World
    By Shunsuke Tani

    PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…

    Cost Effectiveness Assessment (2025-)

    LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
    By Takashi Ebisawa

    Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…

    Off-Year Drug Price Revisions

    Japan to Weigh Necessary Measures for FY2027 Revision: PM

    Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…

    Drug Approval & Reimbursement in 2026

    Imulrio Finally Set for NHI Listing after 296-Day Wait; Zero Rule Strikes Again
    By Takashi Ebisawa

    Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…

    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…

    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,…

    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…

    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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