Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
MHLW Unveils Planned Framework for Conditional Early Approval Scheme
The Ministry of Health, Labor and Welfare (MHLW) on September 28 presented a planned framework for an envisioned “conditional early approval system,” which would apply to treatments for serious diseases for which confirmatory clinical studies are difficult to conduct. Under…
To read the full story
Related Article
- Conditional Early Approval System Gets Underway: MHLW
October 23, 2017
REGULATORY
- 4 Drug Makers Seek Govt Aid to Upgrade Aging Plants: LDP Hearing
August 24, 2026
- 679 Safety Reports Logged for Regenerative Medical Products in 2H FY2025
August 21, 2026
- Japan Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…