Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- Japan Targets Global-Level Growth for Domestic Patented Drug Market
June 25, 2026
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Expert Calls for AMR Ecosystem to Boost Japan Antibiotic Innovation
June 25, 2026
- PMDA Eyes AI as Staffing Shortages Affect Orphan Drug Reviews
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
Recent trends are creating a fascinating push-and-pull effect in the talent market. We’re seeing more positions opening up, but also a greater number of candidates available, particularly in the fields of rare diseases and oncology. This “more positions, more candidates”…
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…