REGULATORY
    Panel OKs Outline of Emergency Approval System Based on “Presumed” Efficacy
    December 6, 2021
    A Japanese health ministry panel on December 3 roughly endorsed an outline of an emergency authorization system that would grant approval for drugs and medical devices based on “presumed efficacy” as long as safety is…

    LATEST

    Japan Panels Agree to Add Myocarditis as ADRs for Pfizer, Moderna Vaccines
    December 6, 2021
    Panels of experts under the Japanese health ministry on December 3 agreed on label revisions for mRNA COVID-19 vaccines developed by Pfizer and Moderna to add myocarditis and pericarditis to their list of clinically significant adverse drug reactions (ADRs).The decision…
    Study Group Launched by Drug Policy Veterans Pushes 6% Adjustment Rate
    December 6, 2021
    Two Japanese pharma policy veterans hailing from the health ministry and the industry set up a study group on drug prices and distribution on December 1, issuing a proposal the same day that opposes the introduction of caps on drug…
    2 mRNA Jabs Ordered to Add Myocarditis to ADR List: Label Revision
    December 6, 2021
    The Ministry of Health, Labor and Welfare (MHLW) on December 3 ordered label revisions for two mRNA COVID-19 vaccines to add myocarditis and pericarditis to their list of clinically significant adverse drug reaction (ADR).The label revisions were ordered for Pfizer’s…

    COMMENTARY

    Public-Private Collaboration Needed to Refine SaMD Regulatory System
    By Izuru Ando

    A year has passed since the Ministry of Health, Labor and Welfare (MHLW) announced its package strategy to fuel the early commercialization of software as a medical device (SaMD) in November last year. A growing number of drug makers are…

    COLUMN

    4 Things You Can Do to Overcome Zoom Overload
    By Philip Carrigan

    Remember what it was like back in March, when we all started working from home? There was a distinct change in the air - a sense of freedom and excitement about the novelty of being able to work from home.…

    FY2021 Drug Maker Employment Survey

    Drug Makers’ Female Manager Ratio at 12.5%; Major Gap between Japan, Foreign Players

    The average ratio of female employees at managerial posts stood at just 12.5% at pharmaceutical companies operating in Japan, a Jiho survey revealed. While foreign drug makers had an average 25.0%, the ratio came to as low as 9.8% for…

    INTERVIEW

    From Treatment to Prevention, Top Expert on AD Research, Aducanumab and Its Implications - 2
    By Yoshinori Sagehashi

    Biogen’s controversial Alzheimer’s drug aducanumab was filed for Japanese regulatory approval in December. If approved, it will be the first…

    FY2020 Drug Pricing Reform

    Japan Panel Hammers Out FY2020 Drug Pricing Reform

    Japan’s key reimbursement policy panel on December 20 approved an outline of its FY2020 drug pricing reform next April, with…

    HTA Debates in 2018-2019

    Japan to Roll Out Cost-Effectiveness Assessment Scheme in April

    Japan will go ahead with the introduction of a cost-effectiveness assessment (CEA) scheme for drugs and medical devices in April…

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