Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel OKs Shipment of 2 Kaketsuken Blood Products
A health ministry panel endorsed the shipment of some inventories of two blood plasma products of the Chemo-Sero-Therapeutic Research Institute on July 21 after they were barred from the market due to their improper manufacturing processes. The Ministry of Health,…
To read the full story
Related Article
- Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty
December 3, 2015
- MHLW Panel Approves Additional Shipment of Kaketsuken’s Venilon, Novact
November 20, 2015
- PAFSC Committee Approves Resumed Shipments of Kaketsuken’s Venilon due to Potential Shortage of Substitutes
October 2, 2015
- Kaketsuken Reports Results of Internal Probe on Improper Blood Product Manufacturing
September 11, 2015
- Kaketsuken Withdraws Earlier Explanation of Blood Products Scandal; Problem Discovered through Information Provided to MHLW
July 23, 2015
- Kaketsuken Likely to Face Administrative Penalty over GMP Violation
June 24, 2015
- Kaketsuken Suspends Shipments of 12 Products Due to Modifications of Approved Manufacturing Procedures
June 9, 2015
REGULATORY
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…