Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PFSB Issues Notification on Submission of Package Inserts Under New Act
The Pharmaceutical and Food Safety Bureau’s (PFSB) Safety Division issued an operational notification on the advance submission of package inserts under the Act on Pharmaceuticals and Medical Devices on September 1. The notification will take effect on November 25. Regarding…
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REGULATORY
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Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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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…