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In the Japanese pharmaceutical market, a Marketing Authorization Holder (MAH) is legally required to commercialize pharmaceutical products. However, companies often face different regulatory and logistical situations regarding their MAH status. This chapter outlines two specific MAH transfer scenarios and demonstrates […]
How a Seamless Marketing Authorization Transfer Enabled a Swift Biopharma Launch in Japan When it comes to bringing high-value biopharmaceuticals to new markets, meticulous planning and flawless execution are essential. This is especially true for products as complex as monoclonal […]
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