Drug Evaluation Committee Guidance for Remote Surveillance (Reexamination) (May 2023)
May 2023
As you are aware, the outbreak of COVID-19 in Japan in 2020 made it difficult to conduct compliance inspections and other activities. Consequently, remote inspections were launched on a trial basis pursuant to the “Guidelines on the Implementation of Provisional Document-Based Compliance Inspections and GCP On-Site Inspections in Light of the COVID-19 Outbreak” (Administrative Notice dated Reiwa 2, May 12), and“Guidelines for the Implementation of Written Compliance Reviews of New Drug Approval Applications, GCP On-Site Inspections of Pharmaceuticals, and GPSP On-Site Inspections of Pharmaceuticals, etc.” (Notice No. 0831-4 dated Reiwa 2, August 31, issued by the Director of the Pharmaceutical Review and Management Division, Pharmaceutical and Living Environment Bureau, Ministry of Health, Labor and Welfare), as well as “Procedures for Conducting Document-Based Compliance Reviews and GCP On-Site Inspections of Drug Approval Application Documents, and Procedures for Conducting Document-Based Compliance Reviews and GPSP On-Site Inspections of Application Documents for Interim Evaluation, Re-examination, and Re-evaluation of Drugs”(Notice from the President of the PMDA, dated August 31, Reiwa 2), it has been explicitly stipulated that remote inspections may be conducted not only during the COVID-19 pandemic but also under normal circumstances.Furthermore, specific procedures were established through documents such as “Methods for Conducting Remote Inspections in Conformity Assessments of Pharmaceuticals and Regenerative Medicine Products” (Notice from the Director of the Review Center, PMDA, dated November 16, Reiwa 2).Furthermore, the PMDA’s Quality Assurance Department has proactively and promptly provided clear and accessible briefings and video presentations to help applicants better understand remote inspections.
Since the pilot phase, the process of verifying supporting documents during remote inspections by PMDA’s Reliability Assurance Department has required significantly more time and effort compared to on-site inspections. We believe that whether or not remote inspections will continue to be conducted hinges on the applicants’ ability to prepare supporting documents that are easy to understand.Therefore, when conducting remote inspections, it is necessary to establish internal systems and procedures to ensure compliance with the “Documents Specified in Section 5 of the ‘Guidelines on the Implementation of Remote Inspections for Conformity Assessments of Pharmaceuticals and Regenerative Medicine Products’” published on the Agency’s website, as well as the content outlined in this document.
In light of the above, we have decided to publish this document, which focuses specifically on remote inspections for re-examination and other compliance inspections. By standardizing the method for presenting supporting documentation, we aim to make the process clearer and enable the implementation of remote inspections that benefit both the Agency and applicants. We hope this document will be of assistance when 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