今弊社で持っているのはCTDのAバージョンです。このバージョンから更新はありますか？もし更新があれば最新版を送ってください。MFの変更手続きをするに当たり、私達はPMDAにまずは簡易相談をする必要があります。その為には、CTDに変更があるかないかを確認し、最新版のCTDを元に相談をし、最終的にMFの変更ができるのです。
評価
52
翻訳 / 英語
- 2019/09/25 15:25:47に投稿されました
At the moment we have a A version of CTD. Is there any update for this?
If so, please let me have the latest version.
For amendment application of MF, we need to consult simply to PMDA first. In this case, we need to make sure any changes for CTD, referring the latest version of CTD, and the amendment of MF will be possible in the end.
If so, please let me have the latest version.
For amendment application of MF, we need to consult simply to PMDA first. In this case, we need to make sure any changes for CTD, referring the latest version of CTD, and the amendment of MF will be possible in the end.
評価
51
翻訳 / 英語
- 2019/09/25 15:25:20に投稿されました
What we have currently is A version of CTD. Do you have any updates from this version? If you have, please send the latest version to me. We need to have a simple consultation to PMDA firstly for proceed the change of MF. We need to confirm whether there are some change on CTD or not, consult based on the latest version CTD, and will be able to change MF finally.
評価
50
翻訳 / 英語
- 2019/09/25 15:27:08に投稿されました
Currently, our company has A version of CTD. Are there any updates since this version? If so, please send us the latest one. As we proceed MF revision, we first need to make a simple consultation to PMDA. In order to do that, we need to confirm whether CTD has any changes or not, consult with the latest CTD, and then finally we can make changes to MF.
