ARCHIVE

REGULATORY NEWS IN BRIEF

October 5, 2009
NovoRapid 50 Mix ApprovedNovo Nordisk Pharma obtained on September 18 marketing approval for the biphasic insulin analogue NovoRapid 50 Mix FlexPen and its cartridge formulation NovoRapid 50 Mix Penfill (recombinant insulin aspart).NovoRapid 50 Mix is a 5:5 combination of ultra…

To read the full story

ARCHIVE

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

By Ken Yoshino

Japan’s FY2026 drug price revision, officially announced on March 5, has landed poorly with the pharmaceutical industry — and the…

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…