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 Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
- Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
- Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
- PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…