For medical device approvals in Japan, the Japanese PMDA must do a GCP compliance inspection of the clinical data with the applicant during a face-to-face meeting. This in-person inspection is normally done in a conference room at the PMDA.
On August 24th, an administrative notice concerning the procedures for GCP compliance inspection was revised, making it possible to do a remote inspection by providing information online, in addition to the conventional method of face-to-face GCP inspections discussed above.
To complement the above administrative notice, the PMDA also issued another administrative notice on the same day explaining how to conduct a remote investigation. When conducting a remote inspection, the applicant will choose one of these 3 methods such as — (1) use the cloud system to present materials to the PMDA investigator, or (2) store the materials on a CD, DVD, or Blu-Ray Disc and send them to the PMDA, or (3) send the paper materials by courier. It is also possible to use a combination of these three methods.
When presenting materials to be inspected to the PMDA using the cloud system, the applicant must set up the cloud system and provide the PMDA investigator with a user ID and password for access. It is also necessary to provide a manual for how to use the cloud system. If the applicant considers using the remote GCP inspection system, prior consultation with the PMDA is also recommended.
Then, the PMDA will examine the information provided and prepare a list of questions for the online session. After that, a “Web inspection” using a web conference system is carried out. In the “Web inspection”, the applicant answers the questions asked by the PMDA.