The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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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