Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA Generic GMP Inspections a Real-World Test to Stem Startup Risks: Official
Japan’s upcoming shift of GMP inspections for newly approved generics to the Pharmaceuticals and Medical Devices Agency (PMDA) will serve as a real-world test of whether closer coordination between regulatory reviews and manufacturing oversight can head off quality problems at…
To read the full story
Related Article
- Japan, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Seeks to Raise Quality of Prefectural Generic GMP Inspections
September 8, 2025
- Japan’s Parliament Enacts Bill to Amend PMD Act
May 15, 2025
- PMDA-Led Inspections Will Help Straighten Up Generic Makers: MHLW Councilor
September 6, 2024
- MHLW Sets Out to Beef Up Inspector Skills with Nationwide Sharing of GMP Reports
February 29, 2024
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
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…