REGULATORY
    Officer Replacement Orders a “Last Resort” under PMD Act: MHLW Official
    By Takashi Ebisawa September 18, 2026
    Japan’s health ministry will use its new authority to order the replacement of responsible officers at drug makers only as a “last resort” in exceptional cases, a senior official says, while stressing that regulators will…

    LATEST

    Japan Panel Sees No Scientific Objection to Capvaxive NIP Addition
    September 18, 2026
    A health ministry panel on September 17 found no scientific objection to adding MSD’s 21-valent pneumococcal conjugate vaccine Capvaxive (PCV21) to Japan’s national immunization program (NIP) for older adults.Members agreed that it would be preferable…
    Tavneos Blue Letter Action “Too Slow,” MHLW Panel Member Says
    September 18, 2026
    A member of a health ministry oversight panel has criticized the time it took Japanese authorities to order a “blue letter” rapid safety communication for Kissei Pharmaceutical’s Tavneos (avacopan), saying the response appears to have…
    Lunsumio Combo Hits PIII Goal in Follicular Lymphoma: Roche
    September 18, 2026
    Roche said on September 17 that Lunsumio (mosunetuzumab) plus lenalidomide met the primary endpoint in the global PIII CELESTIMO trial in relapsed or refractory follicular lymphoma.The study compared Lunsumio plus lenalidomide with rituximab plus lenalidomide. At an interim analysis, 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…

    NEWS CATEGORY

    REGULATORY

    BUSINESS

    ORGANIZATION

    ACADEMIA