Links to major regulatory information of GCP・GPSP Compliance Assessments.
Regulations and Notifications
Drugs
(Before Amendment)
(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)
July 3, 2023 PMDA/CPE Notification No. 325
March 30, 2023 PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1
July 10, 2018 HPB/RDD Notification No. 0710-4 PSEHB/PED Notification No. 0710-2 PSEHB/MDED Notification No. 0710-2
July 10, 2018
Regenerative Medical Products
July 3, 2023 PMDA/CPE Notification No. 325
March 30, 2023 PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1
Medical Devices
（Before Amendment）
(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)
December 26, 2023 PSB/MDED Notification No. 1226-1
March 30, 2023 PSEHB/PED Notification No. 0330-6 PSEHB/MDED Notification No. 0330-1
Former Notifications
July 1, 2013 PFSB/ELD Administrative Notice