Description:

The PMDA provides details for remote inspections known as compliance inspections.

The PMDA conducts the following compliance inspections:

  • Document-based inspection and GCP on-site inspection for approval of drugs and regenerative medical products
  • Document-based inspection and GPSP on-site inspection for interim evaluation, reexamination, and reevaluation of drugs
  • Document-based inspection and GPSP on-site inspection for approval review after conditional and time-limited authorization, reexamination, and reevaluation of regenerative medical products

$30.00