Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…
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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…