Drug Evaluation Committee Guidance for Remote Investigation (Reexamination) Ver3.0 (Created in March 2024)
April 2024
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 was explicitly stipulated that remote inspections may be conducted not only during the COVID-19 pandemic but also under normal circumstances.Since then, notifications and other documents have been revised based on the submission of inspection documents via the Gateway System, more efficient implementation tailored to risk levels, and the streamlining and clarification of required inspection documents.In addition, the PMDA’s Quality Assurance Department (currently the First Quality Assurance Division and the Second Quality Assurance Division) has been promptly conducting proactive and easy-to-understand explanatory sessions and video broadcasts to help applicants better understand remote inspections.
Since the trial period, the process of verifying supporting documents during remote inspections by the Agency’s Reliability Assurance Department has required significantly more time and effort compared to on-site inspections. We believe that whether remote inspections will continue to be conducted hinges on the applicants’ ability to prepare supporting documents that are easy to understand.To achieve this, applicants must familiarize themselves with the materials and video content posted on the Organization’s website and establish internal systems to ensure they can respond promptly and without delay to notifications and other communications.
In light of the above, we have decided to publish this document. Through this document, we are working to ensure that remote inspections can be conducted in a way that benefits both the Organization and the applicants, and we hope it will be of assistance to all companies involved in re-examination and other conformity assessment activities.
Created in March 2024 (ver. 3.0)
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Team 3