TEMPLATE
Checklist for GCP On-site Inspection / Document-based Compliance Assessment for New Drug (for Sponsor)
ABSTRACT — EDITORS' SUMMARY
The Excel checklist PMDA expects sponsors — including foreign sponsors — to complete for GCP on-site and document-based compliance assessments. The PMDA equivalent of the MHRA inspection dossier.
DOCX · DOCUMENT TEMPLATE
METADATA
SOURCE
DOCX · CANONICAL LINK https://www.pmda.go.jp/files/000250263.docx ↗ RELATED · SAME AUTHORITY