REGULATORY
Applications for Partial Modification to Suffice to Change Manufacturing Processes for Biopharmaceuticals: MHLW Notification
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on July 5 that allows drug makers to change manufacturing processes for biopharmaceuticals by filing applications for the partial modification of existing approvals. Up to now, they have been…
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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…





