については、既にMF変更の申請手続きをしており、PMDAから2回目の問い合わせが来ております。貴社が日本市場への見直しを検討している中で、大変恐縮ですが、PMDAへの回答が必要ですので、下記の三つの項目について、ご回答を頂けないでしょうか。2と3については、弊社で行いますが、ルール上、貴社の同意が必要ですので、回答いただけると助かります。第一回の照会事項で回答されましたが１についてNIRからTLCの変更した適切性の説明がなかったので今回第二回の照会事項で再度説明の依頼があった
評価
52
翻訳 / 英語
- 2020/01/08 11:50:23に投稿されました
Regarding ..., an application for revision of MF was already applied and there is an second enquiry from PMDA. Whilst your firm is reconsidering for the market in Japan, would you answer for following three sections because we need to answer to PMDA?
Issues on 2 and 3 will be for our firm but for the rules we require your consent therefore we would be delighted you to explain them, please.
Though there is an answer for the first matter of enquiries, as we have no suitable explanation for the recent change from NIR to TLC for 1, there is a request for asking for the explanation at the second matter of enquiries at this time.
Issues on 2 and 3 will be for our firm but for the rules we require your consent therefore we would be delighted you to explain them, please.
Though there is an answer for the first matter of enquiries, as we have no suitable explanation for the recent change from NIR to TLC for 1, there is a request for asking for the explanation at the second matter of enquiries at this time.
評価
50
翻訳 / 英語
- 2020/01/08 11:47:51に投稿されました
As for xx, I have already made an arrangement of application for changing FM, and PMDA has made an inquiry for the second time. I know that you are discussing reviewing to the Japanese market. I hate to ask you, but would you answer the three items listed below since I have to answer the PMDA. We will handle 2 and 3. However, as we need our agreement by rule, may I ask you to answer them? It was answered in the first reference, but as NIR has not explained appropriateness of change of TLC about 1, they asked us to explain in the second reference this time.
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評価
50
翻訳 / 英語
- 2020/01/08 12:29:06に投稿されました
Regarding that, We have already applied for MF changing, and We’ve just got their inquires as a second time. I am afraid to ask you who are just reviewing Japanese market but It is necessary to answer quickly to PMDA and we can’t do it without your cooperation again. Could I have the answer of Articles below.
Regarding No.2 and 3, We are going to deal with these matters. However, according to the rules and regulation, It requires to have your own answer. We highly appreciate If you will provide us the answer for No.2 and 3 as well.
Regarding article No.1, They asked us again to explain suitable reason for changing from NIR to TLC.
Regarding No.2 and 3, We are going to deal with these matters. However, according to the rules and regulation, It requires to have your own answer. We highly appreciate If you will provide us the answer for No.2 and 3 as well.
Regarding article No.1, They asked us again to explain suitable reason for changing from NIR to TLC.
