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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