REGULATORY
Japan to Revise Revlimid Risk Management Rule in June; February Generic Approval Eyed
A health ministry safety panel on January 24 approved a plan to revise the “RevMate” risk management program for Revlimid (lenalidomide), a blood cancer drug known to cause birth defects, in June, anticipating the listing of its generic versions as…
To read the full story
Related Article
- MHLW Panel OKs Different Safety Scheme for Fujimoto’s Revlimid Generic despite Concerns
June 27, 2024
- First Generics for 11 APIs to Enter NHI Price List, Azilva Faces Most Contenders
June 15, 2023
- MHLW Approves First Generics for Azilva, Revlimid towards June Listing
February 16, 2023
- No Add'l Safety Measures for Xocova Needed “at This Time”: MHLW Panel
December 28, 2022
- Japan Panel OKs Risk Management Measures for Potential Revlimid Generics
May 25, 2022
- MHLW Panel Roughly OKs Scheme for Generic Makers to Join Revlimid Risk Management Program
June 23, 2021
REGULATORY
- MHLW Issues Q&A on Conditional Approval System
May 1, 2026
- Panel Backs Proposal to Allow Antibody Drugs Like Beyfortus in NIP
May 1, 2026
- METI Clarifies Naphtha Comments, Reaffirms Medical Priority
April 30, 2026
- Japan Minister Rules Out Full Self-Pay for OTC-Like Drugs
April 30, 2026
- Govt’s Bio-WG Wraps Up Biopharma Investment Roadmap Draft
April 30, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





