Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA to Conduct Pharmacokinetic Analysis in Pilot Study on Electronic NDA Submissions
An executive member of the Pharmaceuticals and Medical Devices Agency (PMDA) said on March 28 that the PMDA will conduct a pharmacokinetic analysis in a FY2014 pilot study on the submissions of electronic new drug applications (eNDAs). To do so,…
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Japan’s pharmaceutical policy appears to be entering a new phase. The government’s newly approved honebuto policy and growth strategy both…
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,…
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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…