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
PMDA’s “Early Considerations” Start to Pay Off with Faster Reviews
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) says that its recently introduced “early considerations” are streamlining new drug reviews by clarifying regulatory expectations at earlier stages of development. The initiative, launched in 2024, is designed to help companies prepare stronger…
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REGULATORY
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