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
“Annual Reports” Allowed for CMC Changes with Minimal Impact: MHLW
Drug manufacturers will be allowed to submit “annual reports” rather than the current “minor change notifications” when their proposed post-approval manufacturing changes have a relatively minor impact on product quality, according to the health ministry. This rule change is included…
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REGULATORY
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