REGULATORY

PAFSC 2nd Committee Recommends Approval for Novartis’s COPD Drug

September 11, 2012
The Pharmaceutical Affairs and Food Sanitation Council’s (PAFSC) Second Committee on Drugs reviewed and recommended approval for five products/indications on September 6 including Novartis Pharma’s chronic obstructive pulmonary disease (COPD) treatment glycopyrronium bromide. All five products are expected to receive…

To read the full story

REGULATORY

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

By Philip Carrigan

In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…

By Tatsuya Otsuka

Japan’s FY2026 drug pricing reform is set to usher in a new phase for the generics market, effectively bringing an…

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…