Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
COMMENTARY
Picture of Future Regulations on Investigator-Led Clinical Research Emerging
Discussions are nearing their conclusion on whether to regulate investigator-initiated clinical research, which has seen a series of scandals in recent years amid the government’s loose oversight. A panel of experts on clinical research regulations established in April by the…
To read the full story
Related Article
COMMENTARY
- Beyond Elevidys: Next-Generation DMD Therapies Advance through Multiple Approaches
March 11, 2026
- Elevidys Opens New Era for DMD Treatments Targeting the Underlying Cause
March 10, 2026
- ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
March 9, 2026
- G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
February 25, 2026
- Hisamitsu’s MBO: Is Shareholder Accountability Trust-Building or a Shackle?
February 18, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
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…