Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement in the approval process — and the shift could eventually reach Japan as well, as global harmonization work gets underway.…
To read the full story
Related Article
COMMENTARY
- DORA Use Could Expand as Japan Opens Door to “Sleep Disorders” Specialty
July 6, 2026
- New Generic Listings Plunge, Industry Heads for a Shakeout
July 1, 2026
- Adaptation, Diversification Key as Drug Wholesalers Face Profit Squeeze
June 16, 2026
- 20 Years at a Glance: Overseas Sales Surge at Japan Pharma, but R&D Investments Lag
June 9, 2026
- Are Technical Discussions Enough for Japan’s CEA System?
May 25, 2026
Japan is opening a new chapter in sleep medicine. The recent decision to allow medical institutions to advertise “sleep disorders”…
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 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…