The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
REGULATORY
MHLW to Discuss Setting Rules on OTC Switching of Diagnostics at Panel on In Vitro Diagnostics
The Ministry of Health, Labor and Welfare (MHLW) will start discussions on creating rules for the switching of prescription diagnostics to OTC status at the Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Committee on Medical Devices and In Vitro Diagnostics…
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REGULATORY
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PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
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Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…