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, US Launch Talks on Pharma GMP MRA to Ease Inspection Burden
July 3, 2026
- MHLW Gives Kissei until July 21 to Report on Tavneos
July 3, 2026
- Centrist Reform Alliance Warns US MFN Policy Poses “Real Crisis” for Drug Access
July 3, 2026
- Ishin Urges Govt to Make Healthcare, Drug Innovation Core Growth Strategy
July 3, 2026
- MHLW Seeks Sponsors for 6 High-Need Unapproved, Off-Label Drugs
July 2, 2026
The number of newly listed generic drugs in Japan has fallen sharply over the past decade, reflecting structural changes in…
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
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…