Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
Prior Assessment System Is One Step Forward to Quicker NDA Review
The PMDA (Pharmaceuticals and Medical Devices Agency) introduced a “prior assessment consultation system”on a trial basis in 2009. Under this system, preclinical and early clinical data are submitted to and reviewed by the PMDA before an NDA is formally submitted.…
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COMMENTARY
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More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
A few weeks ago, I had coffee with a very talented executive. Let’s call him Kenji. He has a great job, a big salary, and a solid team. But he was unhappy. He felt bored and wanted a new challenge.…
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…