Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Notification on Clinical Trial Documents and Records Cancels Previous Rules on Paper-Based “Original Documents and Duplicate Copies”
The Pharmaceutical and Food Safety Bureau’s (PFSB) Evaluation and Licensing Division sent an administrative notification to prefectures on February 14 regarding the handling of documents and records related to clinical trials. The notification presents a list of documents that must…
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REGULATORY
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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…