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…
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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