Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Orphan Designation to Be Expanded to Include Intractable Diseases Affecting More than 50,000 Patients
The Ministry of Health, Labor and Welfare (MHLW) announced at a meeting of the Pharmaceutical Affairs and Food Sanitation Council’s Pharmaceutical Affairs Council on December 18 that the criteria for designating orphan drugs will be revised in order to expand…
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REGULATORY
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I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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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…