Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Notification on Clinical Trial Documents and Records Cancels Previous Rules on Paper-Based “Original Documents and Duplicate Copies”
The Pharmaceutical and Food Safety Bureau’s (PFSB) Evaluation and Licensing Division sent an administrative notification to prefectures on February 14 regarding the handling of documents and records related to clinical trials. The notification presents a list of documents that must…
To read the full story
REGULATORY
- Nakai Tapped as MHLW’s Top Pharmacy Officer; Ohara to Steer Drug Pricing Reform
August 7, 2026
- Sarclisa SC, Joenja, Kineret, and 7 More Drugs Bound for NHI Listing
August 6, 2026
- Tepezza Price Cut Set at 5.5% under Japan’s CEA Scheme
August 6, 2026
- Dupixent Faces Fourth Re-Pricing under Japan’s SPA-SSS
August 6, 2026
- Chuikyo Clears NHI Listing for Oncolys’ Telomelysin
August 6, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
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.…
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…