Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Revises Biological Raw Material Rules, Clarifies Donor Testing Flexibility
The Ministry of Health, Labor and Welfare (MHLW) said on March 31 that it has revised Japan’s Standards for Biological Raw Materials and issued related guidance, with the changes taking effect the same day. Originally introduced in 2003 in response…
To read the full story
Related Article
REGULATORY
- Outgoing MHLW Pharmacy Chief Eyes AI as Next Frontier for Drug Regulation
August 4, 2026
- Takeda’s Orzeyful Inches Closer to Japan Approval as 1st NT1 Drug
August 4, 2026
- MHLW Gives Fuel Priority to Drug Deliveries in Quake-Hit Kumamoto
August 4, 2026
- Unami Tapped as Japan’s New Top Finance Bureaucrat
August 3, 2026
- MHLW Names Uchiyama New Pharma Bureau Chief in Senior Shakeup
August 3, 2026
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
Adeno-associated virus (AAV) gene therapies have long been viewed as carrying only a minimal risk of insertional mutagenesis — a…
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…