Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 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…
Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…
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…