Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
Japan’s drug regulator is urging biosimilar developers to move away from comparative efficacy studies (CES) as a default and adopt a quality-driven approach to determining what studies are actually needed. Rather than conducting CES “by default,” companies should identify what…
To read the full story
Related Article
REGULATORY
- CEA Expansion Could Make Drug Price Premiums a Liability: JPMA Official
October 16, 2026
- Nipro’s Stemirac Nears 1st Full Nod Conversion for Regenerative Therapy
October 16, 2026
- Japan Set to Compile Support Measures to Secure MCMs by Year-End
October 15, 2026
- Japan to Weigh Necessary Measures for FY2027 Revision: PM
October 15, 2026
- Japan Eyes Multi-Year Funding to Secure MCMs: Takaichi
October 14, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…