REGULATORY
Japan to Set Up Dedicated Team to Expedite Review of Sakigake-Designated Cell/Gene Therapies
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) will establish a team dedicated to reviewing cell and gene therapies designated for its sakigake fast-track pathway in FY2020 as it gears up for a flurry of approvals for these up-and-coming products. Funds…
To read the full story
Related Article
REGULATORY
- Japan Eyes Spring 2027 Plan to Address Drug Discovery Workforce Needs
October 19, 2026
- Minister Lauds Stemirac after Panel Backs Full Approval
October 19, 2026
- CEA Expansion Could Make Drug Price Premiums a Liability: JPMA Official
October 16, 2026
- Nipro’s Stemirac Nears 1st Full Nod Conversion for Regenerative Therapy
October 16, 2026
- Japan Set to Compile Support Measures to Secure MCMs by Year-End
October 15, 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…





