Drug Evaluation Committee Guidance for Remote Surveillance (Re-Evaluation) Ver3.0 (Prepared in March 2024)
Pharmacovigilance Subcommittee
April 2024
As you know, the outbreak of a new type of coronavirus infection in Japan in 2020 will make it difficult to conduct conformity surveys, etc., and the "Treatment of the implementation guidelines for the immediate written conformity survey and GCP on-site survey due to the outbreak of a new type of coronavirus infection" (administrative communication dated May 12, 2020) was issued. The remote investigation was initiated on a trial basis, and the "Implementation Guidelines for Documentary Conformity Surveillance of New Drug Application Documents, GCP On-Site Surveillance of Pharmaceuticals, and GPSP On-Site Surveillance of Pharmaceuticals" (Notification No. 0831-4 dated August 31, 2020 of the Director, Drug Evaluation and Management Division, Pharmaceuticals and Consumer Health Bureau, MHLW), and the "Implementation Guidelines for Documentary Conformity Surveillance of Drug Application Documents for New Drugs In the "Procedures for Conducting Documentary Conformity Surveillance and GCP On-site Surveillance of Application Materials for Approval of Pharmaceuticals" (Notification of the President of Pharmaceuticals and Medical Devices Agency dated August 31, 2020) and "Procedures for Conducting Documentary Conformity Surveillance and GPSP On-site Surveillance of Application Materials for Interim Evaluation, Re-Evaluation and Re-Evaluation of Pharmaceuticals" (Notification of the President of Pharmaceuticals and Medical Devices Agency dated August 31, 2020), it was stated that not only the Corona disaster (Notice of the Director-General of the Independent Administrative Agency, Pharmaceuticals and Medical Devices Agency, dated August 31, 2020), it was clearly stipulated that remote investigations could be conducted not only in the event of a coronary disaster but also in normal times. Subsequently, the notice has been revised based on the submission of survey materials through the gateway system, more efficient implementation according to risk, and rationalization and clarification of the survey materials to be submitted. In addition, the Reliability Assurance Department of ETIC (currently, Reliability Assurance Department 1 and 2) has been actively and timely providing easy-to-understand explanatory meetings and videos to deepen applicants' understanding of the remote survey.
Since the trial period, the work of JQA's Reliability Assurance Department to check the evidence for the remote survey has required more time and effort than the on-site survey, and we believe that the key to whether or not the remote survey will continue to be conducted is how well applicants can prepare easy-to-understand evidence. To this end, it is necessary to establish an internal system to ensure that applicants understand the materials posted on the ETIC website and the video distribution, etc., and that they can respond without delay based on the notices, etc.
Based on the above circumstances, we have decided to publish this document. We hope that this document will be of assistance to those companies involved in reexamination and other conformity assessment activities.
Created in March 2024 (ver. 3.0)
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Response Team 3
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