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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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





