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
New ICH Trial Guidelines to Embrace “Pooled Populations,” but PMDA Unlikely to Accept Zero Japanese
The International Council for Harmonization (ICH) has agreed to incorporate the idea of “pooled populations” in its new guidelines for multi-regional clinical trials to allow for more flexible designs in terms of patient nationalities, but Japanese regulators are unlikely to…
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