Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Expedited Review Systems Now in Place in 3 Major Markets, but How Are They Different?
Three years after the US FDA launched its Breakthrough Therapy (BT) program, Japan introduced its sakigake designation system in 2015, albeit on a trial basis, followed by the EMA’s Priority Medicines (PRIME) scheme in March this year. All three are…
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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…