The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
MHLW Panel Concerned about Further Clinical Trial for Eisai’s Investigational Epilepsy Drug Following Death
The Ministry of Health, Labor and Welfare (MHLW) reported on December 19 results of an investigation into the death of a man who received Eisai’s experimental epilepsy medicine in a PI trial in Japan at a meeting of the Pharmaceutical…
To read the full story
Related Article
- MHLW Revises Safety Guidance on FIH Studies Following Death of Subject
January 6, 2020
- Eisai Discontinues Development of Epilepsy Drug after Death in PI; “Will Never Be Administered to Humans in the Future”
January 6, 2020
- Causal Link between Eisai’s Epilepsy Drug and Trial Death Can’t Be Ruled Out: MHLW
December 2, 2019
- After Death in First-in-Human Study, MHLW Needs to Release Info. to Alleviate Concerns about Participation in Studies
August 26, 2019
- Eisai Halts Epilepsy Drug Studies after Death in Japan PI
July 31, 2019
REGULATORY
- AMED, JPMA Poised to Embed Pharma Expertise in Drug Discovery
January 20, 2026
- Japan’s Lower House Poll Set for Feb. 8 after Takaichi Calls Snap Vote
January 20, 2026
- Daiichi, University of Tokyo Professor Win Japan’s PM Award for Ezharmia Development
January 20, 2026
- Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead
January 19, 2026
- Chuikyo OKs 3.5% Minimum NHI Price Hike, Sets Grace Period for New AG Pricing
January 19, 2026
As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…
Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…
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…