Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA Opens New Office to Prepare for Introduction of CDISC Standards
The Pharmaceuticals and Medical Devices Agency (PMDA) established a new office on April 1 in order to prepare for the introduction in FY2016 of electronic submissions of clinical data with electronic new drug applications (eNDAs) using CDISC (Clinical Data Interchange…
To read the full story
REGULATORY
- Pipe Damage Causes Water Leak at Sawai Plant after Quake: MHLW
July 30, 2026
- MHLW Urges Stable Supply of Drugs after Kumamoto Earthquake
July 30, 2026
- Kumamoto Quake Hits 46 Medical Facilities; No Pharma Damage Yet: MHLW
July 29, 2026
- Japan Shifts Mo-99 Supply Strategy toward Stronger Global Procurement: Panel
July 29, 2026
- 3 Label Expansions Get NHI Coverage on Public Knowledge Pathway
July 29, 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…