Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Won’t Order Novartis to Revise Package Inserts over Delayed ADR Reports, Urges Firms to Inspect Safety Control Regime
The Ministry of Health, Labor and Welfare (MHLW) on February 27 ordered Novartis Pharma to suspend its business for 15 days over its delayed adverse drug reaction (ADR) reporting, but the ministry said the penalty will not entail the revision…
To read the full story
Related Article
REGULATORY
- Paxlovid, Awiqli Braced for NHI Price Cuts after CEAs
June 25, 2026
- Drug Pricing to Be Applied to Oncolys Oncolytic Virus Therapy
June 25, 2026
- Japan Diet Begins Deliberations on Immunization Act Revision
June 25, 2026
- US Opens Probe into German Drug Pricing Policies; Could Japan Be Next?
June 24, 2026
- Japan Awards Sakigake Tag to AbbVie’s Bispecific Etentamig
June 24, 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…