JP · Office of Conformity Audit

PMDA

Pharmaceuticals & Medical Devices Agency

6 documents in the Library — regulations, inspection procedures, guidance, Q&As, and reflection papers.

§ 01 — Agency portal

AGENCY PORTAL · PMDA PMDA Office of Conformity Audit — GCP Inspection Information The agency's own GCP hub — navigation and resources beyond the documents catalogued below.

opens on pmda.go.jp ↗

§ 02 — Documents

PMDA Checklist for GCP On-site Inspection / Document-based Compliance Assessment for New Drug (for Sponsor) NEW TEMPLATE 2023 DOCX · 89 KB PMDA Checklist for GCP On-site Inspection for New Drug (for Medical Institution) NEW TEMPLATE 2023 DOCX · 105 KB PMDA GCP Inspection Submission Forms — Official Download Portal NEW TEMPLATE 2023 HTML · — PMDA Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products NEW PMDA/CPE Notification No. 325 INSPECTION PROCEDURE 2023 PDF · 197 KB PMDA Compliance Inspection under PMD Act — Overview NEW GUIDANCE 2023 PDF · — PMDA Ministerial Ordinance on Good Clinical Practice for Drugs (J-GCP) MHLW Ord. 28 REGULATION 2020 LINK · —