HOME > REGULATORY

    REGULATORY

    ICH’s Guidelines Helped Bring NDMA Contamination Problem to Light: NIHS Officials

    January 24, 2020
    Voluntary recalls have continued over the last year following the detection of the carcinogen N-nitrosodimethylamine or NDMA in a number of drugs. These problems were likely to be found by the introduction of the International Council for Harmonization’s (ICH) guidelines…

    To read the full story

    Related Article

    REGULATORY

    Chuikyo on FY2024 Reimbursement Reform

    MHLW Proposes Tightening 40% Entry Pricing for New Oral Generics

    The Ministry of Health, Labor and Welfare (MHLW) on November 29 proposed a more stringent application of the current 40% entry price rule for first oral generics towards the FY2024 drug pricing reform.Under the current rule, first oral generics are…

    COLUMN

    The Power of Referrals and Who to Ask
    By Philip Carrigan

    Referrals can be an absolute game-changer in recruitment.When someone in your network recommends a candidate, they often have firsthand insight into the person’s skills, work ethic, values and ambitions. This insider knowledge results in higher quality candidates who are a…

    Drug Approval & Reimbursement in 2023

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

    Chugai Pharmaceutical’s Phesgo (pertuzumab + trastuzumab + vorhyaluronidase alfa) and Novartis’ Leqvio (inclisiran) will be newly added to the Japanese reimbursement list along with a batch of other medicines on November 22. Three drugs carry peak sales outlooks of over…

    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…

    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…