REGULATORY
    CDP OKs Bill to Scrap Off-Year Revisions, Aims for Diet Submission Soon
    By Ken Yoshino December 13, 2024
    Japan’s main opposition party, the Constitutional Democratic Party of Japan (CDP), on December 12 approved a draft bill to make drug price revisions a biennial event, effectively blocking off-year revisions except in special cases.The lawmaker-sponsored…

    LATEST

    RaQualia’s Acid Reducer Now Available in 5 Latin American Countries
    December 13, 2024
    RaQualia Pharma said on December 12 that its acid reducer tegoprazan was launched in five Latin American countries through Mexican sublicensing partner Carnot. With this, the drug is now available in a total of 15 nations worldwide.The five markets added…
    Daiichi Kicks Off PIII Quizartinib Study for FLT3-ITD Negative AML
    December 12, 2024
    Daiichi Sankyo said on December 10 that the first patient has been dosed with its FLT3 inhibitor Vanflyta (quizartinib) in a global PIII trial including Japan for the first-line treatment of patients with newly diagnosed…
    EFPIA Japan Issues Joint Statement for Resolving Drug Lags/Losses
    December 12, 2024
    The European Federation of Pharmaceutical Industries and Associations, Japan (EFPIA Japan) on December 11 released a joint statement with patient groups on the issues of drug lags and losses and access to clinical trial information.In…

    COMMENTARY

    Drug Price Gap Hits Record Low, Did Distribution Guidelines Play Any Role?
    By Tatsuya Otsuka

    The average gap between NHI prices and the market prices of listed medicines in Japan stood at a preliminary 5.2%…

    COLUMN

    How to Be a Country Manager
    By Philip Carrigan

    For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…

    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…

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