Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
PMDA’s “Early Considerations” Start to Pay Off with Faster Reviews
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) says that its recently introduced “early considerations” are streamlining new drug reviews by clarifying regulatory expectations at earlier stages of development. The initiative, launched in 2024, is designed to help companies prepare stronger…
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REGULATORY
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Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…