Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Revises Q&A on Nitrosamine Self-Inspections, OKs Use of Interim Control Limit
The Ministry of Health, Labor and Welfare (MHLW) has issued an administrative communication that partially revises its Q&A on self-inspections conducted by drug manufacturers regarding the risks of nitrosamine impurities in their products. When nitrosamines exceeding acceptable levels are detected,…
To read the full story
Related Article
REGULATORY
- Govt Eyes Honebuto Revisions on Biosimilars, MFN Policy
July 7, 2026
- LDP, Ishin Near Deal on Chuikyo Reform to Bolster Drug Discovery
July 7, 2026
- Japan, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Gives Kissei until July 21 to Report on Tavneos
July 3, 2026
- Centrist Reform Alliance Warns US MFN Policy Poses “Real Crisis” for Drug Access
July 3, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
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…