Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Panel OKs Different Safety Scheme for Fujimoto’s Revlimid Generic despite Concerns
A Japanese health ministry panel on June 25 agreed to allow a safety arrangement for Fujimoto Pharmaceutical’s proposed generic of Revlimid (lenalidomide) that is different from the procedure already in place for the original blood cancer drug and its existing…
To read the full story
Related Article
- MHLW Panel Sets Safety Rules for Upcoming Pomalyst Generics
February 2, 2026
- Espha’s Januvia Generic on Approval Roster towards June Listing
February 18, 2025
- Sawai’s Revlimid Generic, BMS’ AG Now Available; Trerief AG Launch Set for Feb. 20
December 8, 2023
- Japan to Revise Revlimid Risk Management Rule in June; February Generic Approval Eyed
January 25, 2023
REGULATORY
- MHLW Set to Launch Searchable Drug Supply Database in April
February 3, 2026
- MHLW Pushes Back GCP Ordinance Revision to Summer
February 3, 2026
- Public Comments Warn Japan’s Drug Pricing System Cannot Reflect Inflation: Chuikyo
February 2, 2026
- Chuikyo Agrees to Apply Originator Optimal-Use Guidelines to Biosimilars
February 2, 2026
- MHLW Panel Sets Safety Rules for Upcoming Pomalyst Generics
February 2, 2026
Japan’s biotech startups are coming under growing pressure as the Tokyo Stock Exchange (TSE) tightens its rules for companies listed…
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…