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 Approves Additional Shipment of Kaketsuken’s Venilon, Novact
A health ministry panel approved the shipment of certain lots of Chemo-Sero-Therapeutic Research Institute’s (Kaketsuken) Venilon-I for IV injection (freeze-dried sulfonated human normal immunoglobulin) and Novact M (freeze-dried human blood coagulation factor IX) on November 18. The shipment of the…
To read the full story
Related Article
- Probe Finds Kaketsuken’s GMP Violations “Extremely Malicious”, MHLW to Impose Penalty
December 3, 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
- MHLW Panel OKs Shipment of 2 Kaketsuken Blood Products
July 22, 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
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 2026
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 FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…