Japan’s Ministry of Health, Labor and Welfare (MHLW) has clarified cases where real-world data (RWD) can be used in regulatory applications for pharmaceuticals. In a notification issued on February 27, the ministry said RWD could serve as supporting evidence in…
To read the full story
Related Article
- MHLW Updates Q&A on Use of Registry Data in Drug Applications
April 1, 2026
- MHLW Issues 15 Notices Ahead of PMD Act Amendment
March 2, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
REGULATORY
- Japan Mulls Target on “Social Security Burden Rate” after CEFP Call
May 25, 2026
- Ishin Deepens Debate on Healthcare Macroeconomic Indexing
May 25, 2026
- Update: Tavneos Slapped with Blue Letter Action in Japan over Liver Injury Risk
May 22, 2026
- Blister Pack Supplies Seen Returning to Normal: Health Minister
May 22, 2026
- LDP “Eto” Study Group Submits Honebuto Proposal to Health Minister
May 22, 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…





