Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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