Provisional Translation
| OTO No. | 308 | Classification | MHW-163 |
|---|---|---|---|
| Date of Acceptance | August 7, 1987 | Ministry/Agency Receiving Complaint | Economic Planning Agency |
| Responsible Ministries | Ministry of Health and Welfare | Related Laws | The Pharmaceutical Affairs Law |
| Complainant | Keidanren (proxy complaint) | Exporting Countries | |
| Subject | Permission to submit the notification of clinical trial design after customs clearance only in the case of raw drug for clinical trials. | ||
| Details of Measures | It was explained that the import of said product ingredient may only be allowed when unavoidable circumstances make it impossible to submit the clinical trial protocol notification prior to the import of product ingredients to be used for clinical trials when an estimated clinical trial protocol and a written pledge to submit the clinical trial protocol notification within three months are attached to the import notification submitted to the pharmaceutical official. | ||
| Classification of Processing | A | Directions | II-a |
| Remarks | Improvement measures were taken on September 17, 1987. | ||