REGULATORY

Japan Safety Panels Recognize 2nd Death Possibly Linked to COVID Vaccine

July 31, 2023
Two Japanese health ministry safety panels recognized the second mortality case with a “reasonably possible causal link” with a COVID-19 vaccine at their joint meeting on July 28. However, the panels still agreed to maintain the current inoculation program, finding…

To read the full story

Related Article

REGULATORY

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Takashi Ebisawa

International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…

By Philip Carrigan

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,…

By Ken Yoshino

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…