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January 6, 2026
Approximately 5 minutes
Points to Consider and Approaches for Utilization of Study Results Obtained from Specified Clinical Research in Applications for Approval of Medical Devices and Regenerative Medical Products in Japan
Points to Consider and Approaches for Utilization of Study Results Obtained from Specified Clinical Research in Applications for Approval of Medical Devices and Regenerative Medical Products in Japan
1. Background and Purpose
As part of supplemental action following the Clinical Trials Act (Act No. 16 of 2017), Japanese regulators clarified that promoting clinical research requires specifying regulatory classifications and mechanisms for using clinical research data in applications for approval of drugs and medical devices. Accordingly, this administrative notice presents examples of points to consider and approaches for using results from specified clinical research for approval applications of medical devices and regenerative medical products, aligning with similar guidance for pharmaceuticals. (pmda.go.jp)
This notice is intended to inform business operators that use of such study results must be determined on a case-by-case basis, considering reliability and relevance to the product’s evaluation. It does not automatically apply to all applications and may be reviewed in light of future regulatory developments. (pmda.go.jp)
2. Determining Use of Specified Clinical Research Results
Whether results from specified clinical research can be utilized as application materials for marketing approval should be determined comprehensively by considering:
- The conduct and design of the specified clinical research, publication status of results, and how related guidelines describe such studies.
- Specific examples of considerations and concepts for ensuring reliability (see section 3 below). Early consultation with PMDA is recommended when considering the use of these results for an approval application. (pmda.go.jp)
3. Ensuring Reliability of Study Results
When results from specified clinical research are used for approval applications, the required level of reliability must be evaluated based on the significance of the research for the application. The investigator should ensure appropriate conduct of the study, including retention of supporting records/documents, and be able to explain how reliability was ensured. This may be assessed by document-based inspection after submission. (pmda.go.jp)
The following are specific examples of considerations and concepts to help fulfill the required level of reliability based on individual application cases:
- The investigator should be able to explain the appropriateness of dataset preparation (from case report form to analysis) and the reliability of the data; the applicant should also be able to confirm these points.
- The investigator should be able to explain that storage and handling of medical devices or regenerative products used in the research were conducted adequately.
- The investigator should be able to justify the monitoring method chosen (e.g., on-site, central, or hybrid) based on risk and feasibility.
- The justification of the audit method selected should be demonstrated as appropriate.
- Review of source records during monitoring/audits may be selective, but the investigator must explain the validity of the selection based on risk and feasibility.
- If an audit is conducted, it should be performed by a third party independent of the research being audited.
- The investigator should be able to explain the collection and validity of information on device malfunctions and related subject protection issues. (pmda.go.jp)
4. Patient Consent and Compliance
If specified clinical research data are used for an approval application, the investigator must have obtained appropriate patient consent allowing use of the study data by the applicant. This consent should cover regulatory submission and any inspections or reviews by authorities. (pmda.go.jp)
5. Practical Implications for Applicants
In practice, applicants considering reliance on specified clinical research results for approval should:
- Plan early consultation with PMDA to assess feasibility and reliability expectations.
- Ensure the research was conducted under appropriate protocols, with clear documentation, monitoring, and audit procedures that support regulatory scrutiny.
- Anticipate potential document inspections and cooperate with clinical investigators to facilitate evidence review.
6. Conclusion
This administrative notice offers illustrative points to consider and approaches for using results from specified clinical research in marketing approval applications for medical devices and regenerative medical products in Japan, emphasising the central role of data reliability and investigator accountability during clinical research design and conduct. (pmda.go.jp)
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