Keytruda, Novel Anti-Flu Drug Join Japan’s First Sakigake Designation List
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
- MHLW Eager to Expedite Commercialization of Sakigake Products: New Bureau Head
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
- One-Month Lag in Regulatory Filing Accepted for Sakigake Designation
September 24, 2015
- 51 Products Officially Filed for Sakigake Designation after MHLW Screening
September 18, 2015
- PMDA to Select Products for Sakigake Review; “Probably 5 to 10” Will Be Designated: Official
September 3, 2015
- Roughly 60 Products Submitted as Candidates for Review under Sakigake Designation System
June 8, 2015
REGULATORY
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
- Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…





