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
ICH Clinical Trial Guidelines Allow Flexibility on Number of Japanese Subjects Needed: PMDA Official
New ICH guidelines on the planning and design of multi-regional clinical trials (MRCTs) will embrace the concept of “pooled populations,” allowing more flexibility on the number or ratio of Japanese patients that need to be enrolled in a study for…
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