Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Japan to Designate International Clinical Trial Hubs in FY2027
August 28, 2026
- MHLW Tax Reform Requests Cover Support for MCM Preparedness
August 28, 2026
- Patient Group Flags Risks of Inconsistent Decisions on OTC-Like Drug Charges
August 28, 2026
- MHLW Pharma Bureau Eyes 12 Billion Yen to Boost Plasma Product Production
August 28, 2026
- Novo, Lilly Want Reimbursement Support for Obesity Care: LDP Hearing
August 28, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…