REGULATORY
2 Years after Full Rollout, Sakigake System Shows Tepid Uptake as Industry Sees Poor Incentives
Two years after Japan introduced the sakigake designation system with full legal backing, only two drugs have been designated under this pathway, of which one was later dropped - in stark contrast to 25 products that had earned the tag…
To read the full story
Related Article
- Sakigake Status Withdrawn for Takeda’s Pevonedistat: MHLW
December 10, 2021
- Olumiant Gets Sakigake Tag for Type I IFN Autoinflammatory Diseases
November 29, 2021
- Takeda’s Pevonedistat Gets 1st Sakigake Tag under PMD Law
August 26, 2021
- Japan Rolls Out Full-Fledged Sakigake System, Designations 2 Times a Year with Tougher Revocation Rules
September 1, 2020
REGULATORY
- Japan OKs Coverage for Susmed Insomnia App, Shionogi ADHD Therapy App
May 15, 2026
- MHLW’s Mori Vows to Make Japan Pharma Market “More Attractive”
May 15, 2026
- MHLW Official Says US MFN Policy Could Be Taken Up by Chuikyo
May 15, 2026
- Oncolys’ Telomelysin Up for Japan Panel Review on May 21
May 15, 2026
- Japan to Launch CEA “Technical Discussions” under MHLW Research Group
May 14, 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…





