PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
REGULATORY
MHLW Eyes 2 Year Transition for Electronic Data Submissions for New Drugs, Biosimilars
Japan’s health ministry plans to require drug makers to file patient-by-patient electronic data for their PII/PIII clinical studies when they seek regulatory approval for new drugs and biosimilars, beginning sometime in FY2016, but it will set a transition period of…
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