Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Kaketsuken Likely to Face Administrative Penalty over GMP Violation
The Ministry of Health, Labor and Welfare (MHLW) is expected to impose an administrative penalty on the Chemo-Sero-Therapeutic Research Institute, better known as Kaketsuken, over its alleged GMP violation involving blood plasma products. The MHLW early this month ordered Kaketsuken…
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
- MHLW Panel OKs Shipment of 2 Kaketsuken Blood Products
July 22, 2015
- Problems at Kaketsuken Remained Undetected Despite 21 On-Site Inspections over 10-Year Period: PMDA
June 26, 2015
- Kaketsuken Suspends Shipments of 12 Products Due to Modifications of Approved Manufacturing Procedures
June 9, 2015
REGULATORY
- Japan to Designate International Clinical Trial Hubs in FY2027
August 28, 2026
- MHLW Tax Reform Requests Cover Support for MCM Preparedness
August 28, 2026
- Patient Group Flags Risks of Inconsistent Decisions on OTC-Like Drug Charges
August 28, 2026
- MHLW Pharma Bureau Eyes 12 Billion Yen to Boost Plasma Product Production
August 28, 2026
- Novo, Lilly Want Reimbursement Support for Obesity Care: LDP Hearing
August 28, 2026
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…