Drug Evaluation Committee Guidance for Remote Surveillance (Reexamination) (May 2023)
May 2023
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. Remote Surveillance was started on a trial basis with 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 The "Procedures for Conducting Conformity Assessment Documentation Surveillance and GPSP On-site Surveillance" (Notice of the Director-General of the Pharmaceuticals and Medical Devices Agency dated August 31, 2020) clearly stipulates that remote surveillance can be conducted not only in the event of the Corona disaster but also in normal times. In addition, the "Methods of Conducting Remote Surveillance in Conformity Surveillance of Pharmaceuticals and Regenerative Medicine Products" (Notice of November 16, 2020, Director-General of the Evaluation Center, Pharmaceuticals and Medical Devices Agency) and other specific procedures were also established. In addition, the Reliability Assurance Department of JMDA has actively and timely provided easy-to-understand explanatory meetings and videos to deepen understanding of the remote survey among applicants.
Since the time of the trial survey, 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 the applicant can prepare easy-to-understand evidence. Therefore, when conducting a remote survey, it is necessary to prepare an internal system, etc., so that the applicant can respond to the contents of the "Documents stipulated in Paragraph 5 of "How to Conduct Remote Surveillance in Conformity Assessment of Pharmaceuticals and Regenerative Medicine Products" and this document, which are available on the NITE website.
In light of the above circumstances, we have decided to publish this document, which focuses on remote investigations in reexamination and other conformity investigations. We hope that this document will be of some help in conducting remote inspections.
Guidance for Remote Surveys (Reassessment) (Ver. 2.1)
Created in May 2023 (Ver. 2.1)
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee Continuing Issues Team 3