Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Rolls Out Full-Fledged Sakigake System, Designations 2 Times a Year with Tougher Revocation Rules
The Ministry of Health, Labor and Welfare (MHLW) on September 1 fully introduced the sakigake designation system, under which it will now invite applications all year long and designate products twice a year, around April and October for the time…
To read the full story
Related Article
- 2 Years after Full Rollout, Sakigake System Shows Tepid Uptake as Industry Sees Poor Incentives
September 21, 2022
- MHLW to Draft Guidelines by Year-End on Use of Patient Registry Data in Drug Filing
October 5, 2020
- Sakigake Status Should Not Be Granted to Novartis Products until It Takes Prevention Measures for Approval Delay: Pharma Bureau Chief
September 8, 2020
- MHLW to Accept Sakigake Applications All Year Long under Amended PMD Law
August 27, 2020
REGULATORY
- CEA Expansion Could Make Drug Price Premiums a Liability: JPMA Official
October 16, 2026
- Nipro’s Stemirac Nears 1st Full Nod Conversion for Regenerative Therapy
October 16, 2026
- Japan Set to Compile Support Measures to Secure MCMs by Year-End
October 15, 2026
- Japan to Weigh Necessary Measures for FY2027 Revision: PM
October 15, 2026
- Japan Eyes Multi-Year Funding to Secure MCMs: Takaichi
October 14, 2026
Japan’s plasma-derived product industry is approaching a turning point as the government prepares to step in with unprecedented support for…
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
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…