Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Submission of CDISC-Based Clinical Data Required from October 2016: Notification
The Ministry of Health, Labor and Welfare issued a notification on April 27, which specified that the ministry will require drug makers to submit electronic clinical trial data based on CDISC standards, beginning with products filed for marketing approval on…
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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…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…