News about GMP/cGMP

09.09.2022

PMDA: English Version on Procedure for Remote Inspections Revised

PMDA: English Version on Procedure for Remote Inspections Revised

The PMDA (Japanese Pharmaceuticals and Medical Devices Agency) published the English translation of the revised document on remote inspections, Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products. The document describes the specific procedure for a remote inspection and how to organize, prepare and share the necessary paperwork for remote assessment by PMDA (we reported).


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


 

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