The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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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