LEXICON
No.22 November 8, 2010

Paper-based compliance inspection
適合性書面調査
On-site compliance inspection
適合性実地調査

適合性書面調査: Raw data (生データ) and other source documents (原資料) are inspected by the PMDA (Pharmaceuticals and Medical Devices Agency; 医薬品医療機器総合機構) to determine whether studies based on which non-clinical and clinical data attached to applications for new drugs and medical devices...

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