Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Wants to Spur Regulatory Use of RWD, but Still Puts Weight on RCTs
The regulatory filing based solely on real-world data (RWD) has been a major topic of the next amendment of the Pharmaceuticals and Medical Devices (PMD) Act. At this time, however, the health ministry does not believe that new drug submissions…
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