Decision and Details
Pharmaceuticals and Medical Devices Agency (PMDA)Results of the OBP-301 “Conformity Document Inspection” and “GCP On-Site Inspection”
Under the Pharmaceuticals and Medical Devices Act, PMDA conducted a conformity document inspection and a GCP on-site inspection. As both inspections were determined to be “conforming,” the reliability of the data from the source documents for OBP-301 through to the marketing application dossier was confirmed.
This matter will have no impact on the Company’s performance for the fiscal year ending December 2026.
| Item | Details |
|---|---|
| Matter Covered | Results of the OBP-301 “Conformity Document Inspection” and “GCP On-Site Inspection” |
| Decision-Making Body | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Impact on Business Performance | This matter will have no impact on the Company’s performance for the fiscal year ending December 2026. |
| Reason | Under the Pharmaceuticals and Medical Devices Act, PMDA conducted a conformity document inspection and a GCP on-site inspection. As both inspections were determined to be “conforming,” the reliability of the data from the source documents for OBP-301 through to the marketing application dossier was confirmed. |
| Governing Rule | Pharmaceutical Regulations |
| Future plans | For OBP-301, which targets esophageal cancer, the Company plans to begin sales in the fiscal year ending December 2026 after obtaining marketing approval from the Minister of Health, Labour and Welfare. |
Items this document does not state (6)
These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.
The reasons the company gives
The company's own explanation, not something inferred from the numbers.The PMDA inspection conducted under the Pharmaceuticals and Medical Devices Act confirmed the reliability of the data from the source documents for OBP-301 through to the marketing application dossier.