The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Novartis Slapped with 15 Day Biz Suspension over Flawed ADR Reporting
The Ministry of Health, Labor and Welfare issued on February 27 a 15 day business suspension order to the Japan arm of Swiss pharma titan Novartis AG over the company’s flawed reporting of adverse drug reactions (ADRs). It is the…
To read the full story
Related Article
- Novartis Japan Told to Improve Business over Delayed Reporting of Nearly 5,500 ADRs
November 16, 2015
- Business Improvement Order Issued to Novartis Japan
November 13, 2015
- Novartis Fails to Report Nearly 5,500 Side Effect Cases, Biz Improvement Order Likely This Month
November 10, 2015
- MHLW Weighs Another Business Improvement Order to Novartis
November 4, 2015
- MHLW Won’t Order Novartis to Revise Package Inserts over Delayed ADR Reports, Urges Firms to Inspect Safety Control Regime
March 2, 2015
- Novartis Offers Apologies over Biz Suspension, Vows to Prevent Recurrence
March 2, 2015
- MHLW Plans Business Suspension Order for Novartis
February 5, 2015
REGULATORY
- LDP, Ishin Fail to Seal Deal on OTC-Like Drugs as Talks Stall over Fiscal-Savings Figure
December 18, 2025
- Japan Moves LLP Payment Hike toward Political Call, Eyes 1/2 or Higher
December 18, 2025
- 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
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…