Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
REGULATORY
MHLW Mulls Sakigake System for SaMD with Medical Device as a Model: Official
The Ministry of Health, Labor and Welfare (MHLW) is contemplating the introduction of a sakigake fast-track designation system for software as a medical device (SaMD) by looking at one for medical devices, the ministry’s medical device review chief said on…
To read the full story
Related Article
REGULATORY
- LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
October 20, 2026
- Japan Eyes Spring 2027 Plan to Address Drug Discovery Workforce Needs
October 19, 2026
- Minister Lauds Stemirac after Panel Backs Full Approval
October 19, 2026
- 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
Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
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 Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…