Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Revises Notifications on Electronic Data Submission as End of Grace Period Approaches
The Ministry of Health, Labor and Welfare (MHLW) on January 24 partially revised two notifications regarding electronic study data submissions for new drug applications, eyeing the termination of the grace period at the end of March 2020. The submission of electronic…
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REGULATORY
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International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…
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…