The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW to Take Strict Action on Xarelto Side Effect Case: Minister
Health Minister Yasuhisa Shiozaki said on May 30 that his ministry will “take strict action” on Bayer Yakuhin, including possibly imposing an administrative penalty, over its failure to appropriately report side effects associated with its major anticoagulant Xarelto (rivaroxaban). Speaking…
To read the full story
Related Article
- Employee Sues Bayer Japan for Emotional Distress over Xarelto Scandal
March 19, 2019
- JPMA Reprimands Bayer over Side Effect Reporting Violation, Chides “Inappropriate” Promotion
October 20, 2017
- (Update) Bayer Told to Improve Practice over ADR Reporting Delays, Gets “Verbal Guidance” for Xarelto Survey Fuss
October 2, 2017
- Bayer Instruction Existed in Patient Info Acquisition, Sales Rep Tells Govt Panel
August 25, 2017
- Whistleblower Bayer Rep Raps “No Instruction” Finding in Xarelto Scandal Probe
July 21, 2017
- Probe Finds No HQ Instruction for Improper Patient Info Acquisition in Xarelto Surveys, Bayer Execs Take 3-Month Pay Cuts
July 18, 2017
- MHLW Orders Bayer Blanket Probe on Side Effect Reporting
May 30, 2017
- Bayer Fails to Report 12 Side Effect Cases for Xarelto, Scandal Probe Finds
May 29, 2017
REGULATORY
- Panel to Weigh Orphan Designation for Tecartus on December 22
December 17, 2025
- LDP League Formally Urges Male HPV Shots Under NIP from FY2026
December 17, 2025
- Solo Distribution Poses Threats to Stable Supplies, Price Negotiations: Survey
December 17, 2025
- MHLW Drafts Guideline Update, Urges Makers to Factor Distribution Costs into WPPs
December 16, 2025
- MHLW to Add Company-Driven Route to “Specific-Use Drug” Designations
December 16, 2025
Japan has presented its latest draft policy direction for its FY2026 drug pricing reform. While the package includes a string…
Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…
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…