Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
E19, M10 Guidelines Expected to Reach Step 2 at Upcoming ICH Meeting in US
The International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use’s (ICH) two guidelines are expected to reach Step 2 at a meeting to be held on November 10-15, a health ministry official told Jiho. At…
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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…
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…