REGULATORY
    Pharma Wages Multi-Front Lobbying amid Push for Leaner Honebuto
    By Ken Yoshino June 12, 2026
    The pharmaceutical industry is broadening its lobbying efforts beyond the Japanese government’s annual “honebuto” policy blueprint this year, as uncertainty grows over how drug policy issues will be divided among several key strategy documents.Industry officials…

    LATEST

    Many Approved AGs Remain Unlisted Despite Final Pre-Reform Opportunity
    June 12, 2026
    Only three APIs were included as authorized generics (AGs) in Japan’s latest biannual generic listing announced on June 11, with a number of previously approved AGs once viewed as candidates for the final pre-reform launch…
    iPark CEO Calls for National AI Drug Discovery Platform at LDP Hearing
    June 12, 2026
    Toshio Fujimoto, CEO of iPark Institute, urged the government on June 11 to establish a shared AI drug discovery platform across Japan’s drug discovery clusters through public-private collaborations.Speaking at a hearing held by the Liberal…
    MHLW Official Urges Proper IRB Selection under New GCP Rules
    June 12, 2026
    A Japanese health ministry official on June 11 stressed the importance of appropriate institutional review board (IRB) selection by pharmaceutical companies under forthcoming revisions to the country’s Good Clinical Practice (GCP) ordinance.Speaking at a briefing…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

    Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

    COMMENTARY

    20 Years at a Glance: Overseas Sales Surge at Japan Pharma, but R&D Investments Lag
    By Hayate Horiguchi

    Japan’s pharmaceutical industry has become a global business over the past two decades. Overseas markets now make up nearly three-quarters…

    COLUMN

    The Patient North Star: How Gilead Japan Redefined Innovation
    By Philip Carrigan

    In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…

    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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