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    REGULATORY

    MHLW Mulls New OTC Class to Bar Online Sales amid Unease over Morning After Pills

    June 14, 2023
    The Ministry of Health, Labor and Welfare (MHLW) is considering setting up a new category of over-the-counter medicines to prohibit some of these products from being sold online as concerns mount over the proposed Rx-to-OTC switching of emergency contraceptives. The…

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    REGULATORY

    COLUMN

    The Power of Referrals and Who to Ask
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    Drug Approval & Reimbursement in 2023

    Listing OK’ed for Phesgo, Leqvio, Epkinly, and More; 30 Billion-Plus Yen Peak Sales for 3 Meds

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    COMMENTARY

    Key Figures in Next Drug Pricing Reform Now All in Place, In What Direction Will They Go for Pro-Innovation Drive?
    By Ken Yoshino

    The main players in the FY2024 reimbursement policy reform are now all in place, with the roster rounded out by the appointment of former health minister Katsunobu Kato for the Liberal Democratic Party’s (LDP) prominent social security post at the…

    MHLW Panel on Generic Industry Structure

    Generic Study Group Discusses Industry Shake-Up through Consortia

    A member of the Ministry of Health, Labor and Welfare’s (MHLW) study group on the generic industry on November 13…

    Chuikyo on FY2024 Reimbursement Reform

    Revisit 25-Plus-Year Listing Requirement for Essential Drugs: Chuikyo Members

    Many members of a key reimbursement policy panel on November 10 called on the health ministry to revisit the current listing requirement of at least 25 years for the designation of essential medicines now that annual revisions have been introduced…

    MHLW Panel on Pharmaceutical Regulations

    MHLW Regulatory Panel OKs New Procedures for Post-Approval Manufacturing Changes
    By Yoshinori Sagehashi

    A health ministry study group on pharmaceutical regulations on October 13 roughly agreed on a reform plan for Japanese regulatory…

    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…