Provisional Translation
| OTO No. | 111 | Classification | MHW-79 |
|---|---|---|---|
| Date of Acceptance | April 28, 1983 | 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 | Sweden |
| Subject | Simplification and speed-up of the procedures to approve a new medicine. | ||
| Details of Measures | It was explained that approval of any new medicine would be examined by the Central Pharmaceutical Affairs Deliberative Council through certain procedures and in the order of reception of applications, if an application is made for approval of the new medicine with the necessary materials attached. It was further explained that concerning improvement of the certification procedures, it was decided to allow direct applications for approval from foreign manufacturers, to allow the transfer of the approval for import of medicines between the importers and to accept the foreign inspection data for the pre-clinical test data, and that efforts were being made to simplify and expedite the certification procedures. |
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| Classification of Processing | A | Directions | II-a |
| Remarks | |||