Japan’s drug pricing panel held its final round of industry hearings on December 10 as it heads toward the FY2026…
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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Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…