REGULATORY
MHLW to Weigh All-Year Invitation for Sakigake Requests: Top Pharmacy Officer
The Ministry of Health, Labor and Welfare (MHLW) is set to consider having applications open all year long for its sakigake designation - the Japan equivalent of the US FDA’s Breakthrough Therapy status, but on a smaller scale thus far…
To read the full story
Related Article
- MHLW to Accept Sakigake Applications All Year Long under Amended PMD Law
August 27, 2020
- Fumi Yamamoto 1st Woman to Become MHLW’s Top Pharmacy Officer
December 23, 2019
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…





