Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Draft Guidelines by Year-End on Use of Patient Registry Data in Drug Filing
The Ministry of Health, Labor and Welfare (MHLW) is drawing up guidelines on patient registry data to enable the use of real world data (RWD) in regulatory applications for drugs, an official has revealed. The ministry intends to present draft…
To read the full story
Related Article
REGULATORY
- Govt to Explore Greater Rewards for Innovative Drugs in Honebuto
June 29, 2026
- MHLW Starts Technical Review of OTC-Like Drug Charge Exemptions
June 29, 2026
- Takeda to Shift Immunoglobulin Production to 10% Formulation
June 29, 2026
- Japan’s Immunoglobulin Self-Sufficiency Rate Falls Below 60%
June 29, 2026
- MOF Panel Renews Push for Full-Scale Off-Year Revision in FY2027
June 29, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…