REGULATORY
Roughly 60 Products Submitted as Candidates for Review under Sakigake Designation System
Drug makers have put forward around 60 products as candidates for review under what the Ministry of Health, Labor and Welfare (MHLW) calls the “sakigake” designation system, Jiho has learned. The products that ultimately receive designation are expected to be…
To read the full story
Related Article
- Commentary: 1st Sakigake Drugs Picked via “Comparative Evaluation”, Will All Qualified Products Get Designated in the Future?
October 28, 2015
- Keytruda, Novel Anti-Flu Drug Join Japan’s First Sakigake Designation List
October 28, 2015
- 6 Drugs Get Sakigake Designation for Fast-Track Review
October 27, 2015
- MHLW Likely to Announce 5 or So Sakigake Products Next Week
October 22, 2015
- 51 Products Officially Filed for Sakigake Designation after MHLW Screening
September 18, 2015
- LDP Eyes Filing of 15 Sakigake Designated Products by FY2018
June 9, 2015
REGULATORY
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
January 14, 2026
- Japan to Stick with 7 New Drug Approval Rounds a Year
January 14, 2026
- MHLW to Set Up Expert Panel on Using Disease Registries in Drug Development
January 13, 2026
- Chuikyo Moves to Allow Special Mixed-Billing for Santen’s Myopia Drug
January 13, 2026
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…





