INSPECTION PROCEDURE Final (March 2025)
Inspection Checkpoints and Judging Principles for Drug Clinical Trials
ABSTRACT — EDITORS' SUMMARY
What NMPA inspectors check and how they grade findings at clinical trial sites. Covers trial conditions, participant rights protection, protocol compliance, data recording and traceability, and trial drug management. The NMPA equivalent of EMA inspection annexes.
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PDF · CANONICAL LINK https://english.nmpa.gov.cn/pdf/KeyPointsandDeterminationPrinciplesforDrugRegistrationInspection(DrugClinicalTrials)-CFDA.docx ↗ RELATED · SAME AUTHORITY