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    REGULATORY

    Japan Again Takes Pass on Emergency Approval for Shionogi’s COVID Pill as Panels Nix Presumed Efficacy

    By Izuru Ando July 21, 2022
    Panels of Japanese experts on July 20 agreed to put off a decision on whether to grant emergency approval for Shionogi’s oral COVID-19 treatment ensitrelvir, concluding that the drug does not demonstrate “presumed efficacy” with its current data alone. Some…

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    REGULATORY

    COMMENTARY

    LLP Info Might Become Inaccessible If New Coverage Rule Speeds Up Exit
    By Takashi Ebisawa

    Long-listed products (LLPs) in Japan will be subject to a new health coverage scheme starting this October. This is expected…

    COLUMN

    Why LinkedIn Isn’t Effective in Japan
    By Philip Carrigan

    In the Western world, LinkedIn is a staple for many recruitment professionals. It has proven to be a powerful tool for networking, talent sourcing and job postings. But in Japan, people don’t use LinkedIn very much.Here’s why LinkedIn isn’t popular…

    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…

    Drug Approval & Reimbursement in 2023

    Japan Approves Label Expansions for Rexulti, Rituxan, and More

    The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…

    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…

    Chuikyo on Off-Year Drug Price Revision

    Healthcare Providers Rap Product Coverage of Off-Year Re-Pricing, Payers Hail Threshold: Chuikyo

    A key Japanese reimbursement policy panel on December 16 approved the government-backed plan for the FY2023 “off-year” drug price revision.…

    Jiho Survey: FY2022 Drug Price Revision

    Authorized Generics Likely Speeding Up G1/G2 Price Cuts for Off-Patent Brands: Jiho Tally

    Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…

    FY2022 Drug Pricing Reform

    MHLW Unveils New List Prices for FY2022 Revision, 18 Off-Patent APIs Face Early “G1” Cuts

    Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…