Changes to the former Notification on Remote Inspection are made on matters related to the procedure as follows:
- Submission through the Gateway System (Electronic Study Data Submission System) is added as a method of documentation submission.
- Points to be considered in preparation of documentation are clarified.
- Points to be considered for documentation prepared in a language other than Japanese or English are added.
- Aspects to be considered related to the cloud system and video conferencing system are clarified.
Source:
PMDA: Remote Inspections