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 to Require RMP Submissions around August for Generics of Blue Letter-Issued Original Drugs
The Ministry of Health, Labor and Welfare (MHLW) will require generic manufacturers to submit risk management plans (RMPs) for generics when flash safety reports are issued to their original products. The MHLW is looking to release a notification regarding generic…
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REGULATORY
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