Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Clarifies Use of Real-World Data in Drug Applications
Japan’s Ministry of Health, Labor and Welfare (MHLW) has clarified cases where real-world data (RWD) can be used in regulatory applications for pharmaceuticals. In a notification issued on February 27, the ministry said RWD could serve as supporting evidence in…
To read the full story
Related Article
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
REGULATORY
- 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
- 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
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…