Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
Kaketsuken Reports Results of Internal Probe on Improper Blood Product Manufacturing
Chemo-Sero-Therapeutic Research Institute (Kaketsuken) on September 9 announced the results of its internal investigation into its use of unapproved manufacturing methods for plasma fraction products derived from blood donated in Japan. The investigation, conducted by Kaketsuken with the participation of…
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 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 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
- Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme
November 6, 2026
- Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
November 6, 2026
- Japan Eyes Multi-Year Investment Support for Wholesalers in FY2027 Budget
November 6, 2026
- Japan Poised to Broker Generic Firms’ Product Consolidation Talks
November 6, 2026
- Japan Issues Guidance on AI Model Use in Drug Manufacturing, Quality Control
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…