Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Exemption of Clinical Trials in Japanese Subjects Depends on Factors Such as Possibility to Infer Safety: PMDA
The Pharmaceuticals and Medical Devices Agency (PMDA) explained on November 24 its criteria for the exemption of long-term clinical trials in Japanese subjects. At a workshop held by the PMDA and industry organizations including the Japan Pharmaceutical Manufacturers Association (JPMA)…
To read the full story
REGULATORY
- 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
- Japan to Ease Olanzapine Diabetes Contraindication for Antiemetic Use
July 31, 2026
- 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
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…