Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
ICH Reaches Agreement to Treat Subjects with Similar Ethnic Factors as Single Populations Regardless of Nationality
The International Council for Harmonization (ICH) agreed to include an idea of “pooled populations” in its E17 Guideline (Multi-Regional Clinical Trials) at its meeting in Jacksonville, Florida, an official of the Pharmaceuticals and Medical Devices Agency (PMDA) said in a…
To read the full story
Related Article
REGULATORY
- US Opens Probe into German Drug Pricing Policies; Could Japan Be Next?
June 24, 2026
- Japan Awards Sakigake Tag to AbbVie’s Bispecific Etentamig
June 24, 2026
- Japan Grants Orphan Status to Vanda, Quoin Drugs, and Lots More
June 24, 2026
- Carvykti Earlier Use Up for Japan Panel Review on June 29
June 23, 2026
- Kampo Industry Calls for Predictable Drug Pricing to Support Stable Supply
June 23, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…