REGULATORY
    PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
    By Takashi Ebisawa September 8, 2026
    Japan’s upcoming shift of GMP inspections for newly approved generics to the Pharmaceuticals and Medical Devices Agency (PMDA) will serve as a real-world test of whether closer coordination between regulatory reviews and manufacturing oversight can…

    LATEST

    CEA Review Finds Past Decisions Sound, Sees Room for More Transparency
    September 8, 2026
    Japan’s past cost-effectiveness assessment (CEA) decisions have been broadly sound from a technical standpoint, but the process needs greater transparency and more company involvement, according to the final report compiled by a health ministry-funded review…
    Kineret Could Bring Earlier Remission in Still’s Disease: Expert
    September 8, 2026
    The launch of Swedish Orphan Biovitrum Japan’s (Sobi Japan) IL-1 receptor antagonist Kineret (anakinra) could make earlier remission a realistic goal for patients with Still’s disease, a Japanese expert says.“With Kineret, early remission of Still’s…
    Prix Galien to Launch Japan Awards in February 2027
    September 8, 2026
    The Prix Galien, an international award recognizing innovation in pharmaceuticals and medical technology, will be held in Japan for the first time in 2027, the Galien Foundation said on September 7.Takashi Kadowaki, president of 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

    As US Pushes Global Cost Rebalancing, Can Japan Answer with Drug Prices?
    By Ken Yoshino

    Japanese Prime Minister Sanae Takaichi has pledged to respond to the US most-favored-nation (MFN) drug pricing policy to safeguard timely…

    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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