Provisional Translation
| OTO No. | 18 | Classification | MHW-48 |
|---|---|---|---|
| Date of Acceptance | March 12, 1982 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Domestic firm | Exporting Countries | USA |
| Subject | Acceptance of data generated abroad (stability data and clinical test) for the import of in vitro pharmaceuticals. | ||
| Details of Measures | As regards stability test data, data generated abroad has been already accepted if such data are obtained from studies conducted in accordance with standards in Japan. As regards clinical test data, it was explained to the complainant that the acceptance of data generated abroad was difficult as in the case of other pharmaceuticals. The explanation was accepted. | ||
| Classification of Processing | Ca | Directions | II-b |
| Remarks | |||