The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
Commentary: 1st Sakigake Drugs Picked via “Comparative Evaluation”, Will All Qualified Products Get Designated in the Future?
The designation of six drugs was announced for what is called the “sakigake” fast-track review system. With the system being rolled out on a pilot basis this year and regulators’ review structure short-handed, however, some products slipped out of the…
To read the full story
Related Article
- 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
- 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 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
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…