Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Report of Changes to Package Inserts to Be Required Before Providing Revised Information to Healthcare Professionals Under New System
Advance submission of package inserts will become mandatory with the enforcement of the Act on Pharmaceuticals and Medical Devices in November. Marketing authorization holders will be required to submit package inserts before marketing new drugs and to report when they…
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REGULATORY
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