Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ICH-S9 Guideline to Apply to Non-Clinical Studies for “Serious Malignancies”
The International Council for Harmonization’s (ICH) S9 Guideline (Nonclinical Evaluation for Anticancer Pharmaceuticals) will apply to drugs that are intended to treat cancer in patients with serious and life threatening malignancies, and it will not determine the thresholds of seriousness…
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REGULATORY
- Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
March 6, 2026
- Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
March 6, 2026
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Japan's Revised Drug Distribution Guidelines Take Effect
March 6, 2026
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…