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    REGULATORY

    Nitrosamine Guideline to Be Proposed as New Topic for ICH at Fukuoka Confab

    By Shinya Sato May 31, 2024
    The drafting of a guideline to address the problem of nitrosamine contamination in pharmaceuticals is expected to be proposed as a new topic at the Fukuoka assembly of the International Council for Harmonization (ICH), set for a five-day run from…

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    REGULATORY

    Chuikyo Debate on FY2026 Drug Pricing Reform

    MHLW Floats Deducting Private-Practice Use for Re-Pricing, but Off-Cycle Cuts Possible; GLP-1 Eyed?

    Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…

    COMMENTARY

    FY2026 Reform Debate for Drug Pricing Nears the Finish Line, Balance Needed
    By Takashi Ebisawa

    Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…

    COLUMN

    AI in HR: Navigating the Ethical Minefield
    By Philip Carrigan

    Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…

    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…