Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Add Type 1 Diabetes to Opdivo Label: MHLW
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on November 24, calling on Ono Pharmaceutical to add type 1 diabetes to a list of clinically significant adverse drug reactions (ADRs) in the package insert for its anti-PD-1…
To read the full story
Related Article
- MHLW Sends Alert on Opdivo’s Fulminant Type 1 Diabetes Risk
February 1, 2016
- Careful Administration Re-stressed for Inavir, Relenza in Dairy-Sensitive Patients: Safety Bulletin
January 8, 2016
- PMDA Reviewing Opdivo for Risk of Type 1 Diabetes
November 4, 2015
REGULATORY
- MHLW to Allow OTC Drugs to Match Prescription Doses under Specific Conditions
February 5, 2026
- Japan Launches Biotechnology Working Group, Roadmap Draft Due in April
February 4, 2026
- Japan Panel Backs Nonprescription Switch of Second Emergency Contraceptive
February 4, 2026
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
Japan’s Biological Raw Material Rules Enter Major Revision; Clarity on Benefits and Safety Holds Key
Japan is poised to make the most sweeping revision in eight years to the Standards for Biological Raw Materials —…
The Japanese healthcare sector is experiencing rapid growth, demanding a highly skilled and diverse workforce. However, finding and attracting the best talent in this competitive market presents significant challenges.Enter AI. With the rise of AI-powered tools, healthcare organizations can revolutionize…
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…