Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PFSB Issues First Guidance on Quality Evaluation of Antibody Drugs
The Pharmaceutical and Food Safety Bureau’s Evaluation and Licensing Division issued a notification to prefectures on December 14 to provide guidance on the quality evaluation of antibody drugs. The notification lists precautions on the manufacturing, characterization, specifications, and test methods…
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REGULATORY
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A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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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…