PMDA publishes Remote Inspection Guidance
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The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has published an English version of its "Procedure for Remote Inspection as a part of compliance inspection on drugs and regenerative medical products".
The document describes the concrete procedure of a remote inspection, clarifies how to proceed with the necessary documents and reflects expectations to video conferencing systems.
The PMDA sets a clear time point for document requests: "by 10:00 am, 13 business days before the main-inspection", the auditee ("applicant") should be informed by the inspector. Then the applicant has three days to provide the documents. This leads to a so-called Pre-Inspection, in which the inspector checks the documents. In the main inspection, which is then conducted as a video conference, the inspector can request further documents, but will mainly deal with concerns and possible questions about the documents already requested. How all these documents can be presented is explained in detail in the document.
The applicant is responsible for the costs, quality, set-up and security of the data transmission and the video conference. This is also described in detail.
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