REGULATORY
MHLW Notifies of Guidelines on Use of Registry Data in Regulatory Submissions
The Ministry of Health, Labor and Welfare (MHLW) issued on March 23 guidelines on the use of real world data from actual clinical settings in regulatory filings. The guidelines on the “basic policy on the use of registry data in…
To read the full story
Related Article
REGULATORY
- US Narrows Scope of Medicare MFN Model, Exempts Orphan-Only Drugs
October 2, 2026
- Japan to Draw Up Growth Strategy Action Plan by Year-End
October 2, 2026
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…





