REGULATORY
Fulminant Hepatitis Added to Precautions Section of Package Insert for Regorafenib: MHLW Safety Information
The Ministry of Health, Labor and Welfare’s (MHLW) Pharmaceutical and Food Safety Bureau published Pharmaceuticals and Medical Devices Safety Information No. 311 on March 26. Among other things, it announced that fulminant hepatitis and interstitial lung disease have been added…
To read the full story
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…





