Overview:
On November 16, 2020, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) published Notification PMDA/CPE Notification No. PMDA1116002, that clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.
The objective of the compliance inspections is to assess compliance to good clinical practices of drugs and regenerative medicines submitted for approval, or in post-marketing stage.
PMDA Compliance Inspections:
Compliance inspections include the following:
- Document-based inspection and GCP on-site inspection for approval of drugs and regenerative medical products
- Document-based inspection and GPSP on-site inspection for interim evaluation, reexamination, and reevaluation of drugs
- Document-based inspection and GPSP on-site inspection for approval review after conditional and time-limited authorization, reexamination, and reevaluation of regenerative medical products
Remote Inspection Procedure:
The PMDA procedure for remote inspection covers the following points:
1. Prior communication about Remote Inspection
- PMDA will inform an applicant of its plans to conduct a remote inspection and share a schedule.
2. Presentation of documentation with related timelines
- The applicant will need to present documentation for PMDA staff review in a pre-inspection step.
3. Pre-inspection activities
- The inspectors will tell the applicant of any concerns identified during the pre-inspection before the main assessment.
4. Main-inspection activities
- PMDA will use the main inspection to interview the applicant via video conference and view documents not shared ahead of time. Further interactions may happen after the inspection.
5. Post-inspection actions
Further interactions may happen after the inspection
Regulatory Corner:
To help applicants prepare for such inspections, PMDA has created points to consider regarding documentation and the cloud and video conferencing systems used to enable remote inspections. PMDA is asking applicants to establish procedures for scanning paper documents that result in clear, complete and consistent digital versions of the physical files.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices , pharmaceutical, cosmetic and food supplement companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
Japan's PMDA
PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. They protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.