REGULATORY
MHLW to Revise Biosimilar Guidelines to Increase Efficiency in Development, Review; Final Draft Expected in FY2019
The Ministry of Health, Labor and Welfare (MHLW) plans to update its biosimilar guidelines after a decade with the aim of increasing efficiency in development and reviews, with a study group discussing the revision expected to hammer out a final…
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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…





