Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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