Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
REGULATORY
MHLW Likely to Announce 5 or So Sakigake Products Next Week
The Ministry of Health, Labor and Welfare (MHLW) plans to designate around five drugs under its much-heralded sakigake fast-track review system, which is being rolled out on a trial basis this year, Jiho has learned. The five or so products…
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
- 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
- Kyowa Kirin’s Libmeldy Gene Therapy Now in Line for Japan Approval
November 10, 2026
- Astellas Employee Jailed for Espionage in China Set for December Release
November 10, 2026
- Nearly 1,200 COVID Vaccine Injury Relief Claims Still Await Review in Japan
November 10, 2026
- LDP League Seeks Drug Pricing Revamp to Support Patches
November 10, 2026
- Keytruda SC Tops New NHI Listing Round with 75 Billion Yen Sales Outlook
November 9, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…