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Japan’s Early Consideration on Handling of Japanese Data for Biosimilar Comparability
Introduction to Regulatory Perspective According to the PMDA’s provisional translation released on September 1 […]
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Expediting Drug Development in Japan: Key PMDA Initiatives
IntroductionPMDA has reduced median new drug review times from over 600 days in 2005 to 333 days in 2023, matc […]