Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
4 Eligibility Criteria Presented for Conditional Early Approval System
The Ministry of Health, Labor and Welfare (MHLW) on June 1 presented four criteria that would make drugs eligible for a conditional early approval system, whose introduction was agreed upon by the regulator and pharmaceutical industry leaders earlier this year.…
To read the full story
Related Article
- MHLW to Announce Data Required for Conditional Early Approval
July 12, 2017
- MHLW Mulling to Add Clinical Trial Data for Generic Labels
June 2, 2017
- 3rd Sakigake Invitation for Drugs Slated for This Autumn: MHLW
June 2, 2017
- MHLW, Pharma Industry Officials Agree on Conditional Early Approval System
January 31, 2017
REGULATORY
- Japan Panel Again Defers Male HPV Shots amid Cost-Effectiveness Concerns
October 9, 2026
- Takaichi Defends Off-Year Drug Price Revisions as DPP Calls for Abolition
October 9, 2026
- Japan Orders Contraindication for Adlumiz-Noxafil Combination
October 9, 2026
- Imcivree, Hibsago Get Chuikyo Nod for Home Self-Injection
October 9, 2026
- Provider-Payer Tug-of-War Takes Shape over FY2027 Drug Price Revision
October 8, 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…