The Central Social Insurance Medical Council, a key Japanese reimbursement policy panel better known as Chuikyo, approved an outline of…
REGULATORY
Notification on Clinical Trial Documents and Records Cancels Previous Rules on Paper-Based “Original Documents and Duplicate Copies”
The Pharmaceutical and Food Safety Bureau’s (PFSB) Evaluation and Licensing Division sent an administrative notification to prefectures on February 14 regarding the handling of documents and records related to clinical trials. The notification presents a list of documents that must…
To read the full story
REGULATORY
- Japan Panel to Review Pfizer’s Cancer Med Tukysa on January 29
January 16, 2026
- Study Group Calls for Independent Body to Centrally Manage Whole Genome Data
January 16, 2026
- Expert Calls for Full Verification of CEA Guidelines and Analytical Frameworks
January 16, 2026
- Japan Sets New Pricing Rules for Conditionally Approved Regenerative Medicines, Starting with Elevidys
January 15, 2026
- MHLW Orders Label Revisions for Aspirin, CAR-T Therapies, and Other Drugs
January 14, 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…