PMDA Office of Conformity Audit — GCP Inspection Information

ABSTRACT — EDITORS' SUMMARY

PMDA English-language landing page for GCP conformity audit procedures, J-GCP, and inspection-related notifications.

MIRRORED FROM AGENCY

日本語ページはこちら

Links to major regulatory information of GCP・GPSP Compliance Assessments.

Regulations and Notifications

Drugs

(Before Amendment)

Ministerial Ordinance on Good Clinical Practice for Drugs [73.55KB] ^(Note)

^(Note)The latest version is available only in Japanese.

（In Japanese） Ministerial Ordinance on Good Clinical Practice for Drugs [238KB]

Ordinance of the Ministry of Health and Welfare No. 28 of March 27, 1997 (As last amended by the Ordinance of Ministry of Health, Labour and Welfare No. 161 of December 26, 2023)

Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[197.21KB]

July 3, 2023 PMDA/CPE Notification No. 325

Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials[104.50KB]

March 30, 2023 PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1

Partial Revision of New “Standard Forms for requesting clinical trials, etc.”[158.70KB]

July 10, 2018　HPB/RDD Notification No. 0710-4　PSEHB/PED Notification No. 0710-2　PSEHB/MDED Notification No. 0710-2

New “Standard Forms for Requesting Clinical Trials, etc.”[807.13KB]

July 10, 2018

Regenerative Medical Products

Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products[197.21KB]

July 3, 2023 PMDA/CPE Notification No. 325

Points to Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials[104.50KB]

March 30, 2023 PSEHB/PED Notification No. 0330-6　PSEHB/MDED Notification No. 0330-1

Medical Devices

（Before Amendment）

Ministerial Ordinance on Good Clinical Practice for Medical Devices[321KB]^(Note)

^(Note)The latest version is available only in Japanese.

（In Japanese）Ministerial Ordinance on Good Clinical Practice for Medical Devices[134.45KB]
Ordinance of the Ministry of Health and Welfare No. 36 of March 23, 2005 (As last amended by the Ordinance of Ministry of Health, Labour and Welfare No. 161 of December 26, 2023)

（In Japanese）Partial revision of the “Guidance for “Ministerial Ordinance on Good Clinical Practice for Medical Devices” ”[885.31KB]

December 26, 2023 PSB/MDED Notification No. 1226-1