REGULATORY
Japan Filing within 3 Months of Global Submission Eligible for Sakigake: MHLW
The Ministry of Health, Labor and Welfare (MHLW) on December 22 issued a notification updating its operational rule for the sakigake designation system, clarifying its eligibility requirement pertaining to the timing of regulatory submissions. One of its eligibility criteria, the…
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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…





