A社としてQ11の定義に従い、ベンズアルデヒドは試薬として管理する回答は分かりましたので、PMDAにはそのように回答いたします。
ただ、11月に、弊社からステップ2からベンズアルデヒドを削除した理由を聞いた時に、あなたから下記の回答をもらいましたので、MFには再度記載します。20にはPMDAに回答をしなければならないので、今日中にあなたの同意が必要です。問題なければ一言返信を頂けると助かります。
評価
51
翻訳 / 英語
- 2020/01/17 15:49:03に投稿されました
I understand that A company follow the definition of Q11 and manage benzaldehyde as the test medicine, so I will reply to PMDA that.
However, as I heard from your company the reason that benzaldehyde was deleted from step 2 on November, I received the answer from you as below. So, I will write again on MF. I have to reply to PMDA on 20, so need your agreement by the end of today. It would be helpful for me that you could reply if there is no problem.
However, as I heard from your company the reason that benzaldehyde was deleted from step 2 on November, I received the answer from you as below. So, I will write again on MF. I have to reply to PMDA on 20, so need your agreement by the end of today. It would be helpful for me that you could reply if there is no problem.
評価
52
翻訳 / 英語
- 2020/01/17 15:54:40に投稿されました
We understand the benzaldehyde is to be managed as a reagent, which is complying with Q11 for A, therefore we will answer to PMDA.
However, in the past November, when the benzaldehyde was removed from step 2, we asked the reason, we have received the answer for following. We will note on MF again.
For 20 we must reply to PMDA, we need your consent by today.
If you don't have any worries, please reply so.
However, in the past November, when the benzaldehyde was removed from step 2, we asked the reason, we have received the answer for following. We will note on MF again.
For 20 we must reply to PMDA, we need your consent by today.
If you don't have any worries, please reply so.
