Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Draft GL on Use of Real World Data in Application Filings to Promote Development of Drugs for Rare Diseases
The Ministry of Health, Labor and Welfare (MHLW) plans to draft guidelines for using real world data in marketing authorization applications for ethical drugs. The guidelines will cover requirements for using real world data from national patient registries as control…
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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,…
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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…