Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan Eyes 1st Revision in 15 Years for Cancer Drug Development Guidelines to Deal with Rare Subtypes, Tumor-Agnostic Indications
A study group of the Japan Agency for Medical Research and Development (AMED) has been conducting a study for the revision of the health ministry’s guidelines for the clinical evaluation of anticancer drugs, aiming to lay out approaches to development…
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REGULATORY
- Council Floats 9.6% Growth Target for Japan’s On-Patent Drug Market
March 11, 2026
- MHLW Approves Towa Generics for Revolade, Vimpat
March 11, 2026
- Panel Clears Zolgensma Intrathecal Form to Expand Use in Older SMA Patients
March 10, 2026
- Japan Approves MSD’s HIV Combo Idvynso
March 9, 2026
- MHLW Updates Elective Care LLP List; Target Products Down Sharply to 776
March 9, 2026
Chugai Pharmaceutical’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys has finally reached the Japanese market after months of safety reviews…
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…