Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
PMDA to Modify Onsite GCP Inspections Based on Facility Track Records
The Pharmaceuticals and Medical Devices Agency (PMDA) has modified the operational rules of onsite Good Clinical Practice (GCP) inspections, setting requirements based on the track records of facilities that participate in clinical trials, effective January 31. The PMDA conducts GCP…
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REGULATORY
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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…
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Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…