The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
Japan Eyes Withdrawal Rule for Conditional Approval, More Flexible Nods
Japan has started weighing the introduction of a withdrawal rule for its conditional approval system, which grants regulatory clearance with strings attached when PIII confirmatory trials are not feasible due to small patient populations or other such reasons. The Ministry…
To read the full story
Related Article
- Advisory Panel Backs Transfer of GMP Inspection Authority for New Generics to PMDA
November 5, 2024
- Panel OKs Withdrawal Rule for Conditional Nod, 2-Year Extension for Pediatric Data Protection towards PMD Act Amendment
October 4, 2024
- MHLW Panel to Draw Up Report by Year-End towards Amendment of PMD Act
February 13, 2024
REGULATORY
- MHLW Pharma Director Says Uniform Drug Price Hike “Not Realistic,” Targeted Support Preferred
January 9, 2026
- MHLW Issues Guidance on Revised PMD Act Ahead of May Enforcement
January 6, 2026
- MHLW Sets Up Drug Discovery Support Office Ahead of New Fund Launch
January 6, 2026
- Ex-JPMA President Ueno Takes on New AMED Advisor Role
January 6, 2026
- Cabinet OKs FY2026 Tax Reform Package, Creates Strategic Tech R&D Credit
January 5, 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…