REGULATORY
    Japan Mulls Amendment of GCP Ordinance, Making Single IRBs a Rule
    By Sakura Kono April 3, 2025
    The Japanese health ministry is considering an amendment of its good clinical practice (GCP) ordinance with an eye towards incorporating the principle of a single institutional review board (IRB) per trial. The timeline for such…

    LATEST

    Susaki City to Subsidize Beyfortus Use in Healthy Babies
    April 3, 2025
    The city of Susaki in the western Japan prefecture of Kochi will launch what it claims to be the first initiative in the country to subsidize the use of the anti-respiratory syncytial virus (RSV) antibody…
    JIHS Now Up and Running as Japan Version of CDC
    April 3, 2025
    The Japanese government has launched the Japan Institute for Health Security (JIHS), or the so-called Japan version of the US Centers for Disease Control and Prevention (CDC), in a bid to ramp up the country’s pandemic preparedness.The new body was…
    PMD Act Amendment to Enter Diet Debate; Parallel Deliberations Planned for Bill to Scrap Off-Year Revisions
    April 3, 2025
    Japan’s ruling and opposition parties have agreed to start parliamentary deliberations for a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at a Lower House session on April 4.There will be a briefing…

    COMMENTARY

    How Will Japan Deal with Expected Cost Spike with Japan-Made Antibiotic APIs?
    By Takashi Ebisawa

    Japan relies almost entirely on China for the APIs of β-lactam antibiotics. These drugs are essential for treating infectious diseases…

    COLUMN

    Build a Strong Employer Brand - What Can You Do If Your Company Stinks?
    By Philip Carrigan

    Your company’s employer brand is your reputation as an employer and is crucial in attracting top talent. Some reputations are just not good; they may or not be deserved. That is just the perception in the market. Years ago there…

    Discussions on Next PMD Act Amendment

    Quality Assurance and Lag/Loss Fight to Form Pillars of PMD Act Amendment
    By Takashi Ebisawa

    A Japanese health ministry panel on December 26 wrapped up its discussions on the next amendment of the Pharmaceuticals and…

    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 Debate on Off-Year Drug Price Revisions

    Chuikyo OKs Outline of FY2025 Off-Year Drug Price Revision
    By Ken Yoshino

    Japan’s key reimbursement policy panel on December 25 approved an outline of the FY2025 drug price revision, finalizing plans to…

    TRENDS

    Top 10 PHARMA JAPAN Articles of 2024

    For the first time in many years, Japan appeared to have pivoted to a pro-innovation path with the FY2024 drug pricing reform. All eyes were apparently on this course change as seen in this year’s most-read story list, though the…

    MHLW Panel on Generic Industry Structure

    MHLW Panel Draws Up Plans for Generic Industry Shakeup in Final Report

    A Japanese health ministry panel discussing the generic industry structure on May 22 put together a report in which it…

    MHLW Panel on Pharmaceutical Regulations

    Japan Set to Push Central IRBs for Clinical Trials, Avoid Customary All-Case PMS

    A Japanese health ministry study group focused on pharmaceutical regulations on March 21 agreed on a policy to encourage the…

    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…

    MHLW Expert Panel on Comprehensive Policies

    Expert Panel Broadly OKs Draft Report on Pharma Policies, Further Deliberations by Other Forums
    By Yoshinori Sagehashi

    The Japanese health ministry’s expert panel tasked to discuss comprehensive policies for the rapid and stable supply of pharmaceuticals generally…

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