Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
After Repeated Scandals, PMDA Sets Up New Division to Provide GMP Inspection Know-How to Prefectures
In the wake of a series of manufacturing violations around the country, the Pharmaceuticals and Medical Devices Agency (PMDA) set up a dedicated division on GMP education support this April to improve the quality of onsite inspections by prefectural authorities.…
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REGULATORY
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Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…