今回のA製品のMF変更をPMDAに申請をし、申請内容に対し、PMDAからお問い合わせをいただいています。1番から5番まで、全部で5項目ありますが、1番の質問にある、"missing of corrected and added to JDMF"と"Actual change"については、変更の申請時に、申請理由の項目がありますが、その中の二つです。追って、申請理由のリストを送付します。
評価
52
翻訳 / 英語
- 2019/11/21 08:17:22に投稿されました
We have applied PMDA for the change of MF of the product A at this time.
Regarding the application, we have received an enquiry from PMDA.
There is 5 categories from section 1 to 5.
On the question 1 saying "missing of corrected and added to JDMF" and "Actual change" means two out of the sections of "reason of application" when submitting the change.
Therefore I will send a list of "reason of application" for you soon.
Regarding the application, we have received an enquiry from PMDA.
There is 5 categories from section 1 to 5.
On the question 1 saying "missing of corrected and added to JDMF" and "Actual change" means two out of the sections of "reason of application" when submitting the change.
Therefore I will send a list of "reason of application" for you soon.
評価
50
翻訳 / 英語
- 2019/11/21 08:17:15に投稿されました
I filed PMDA about change of MF of A this, and PMDA inquired about details of what I filed. There are 5 from 1 to 5 in total. As for "missing of corrected and added to JDMF" and "Actual change" in the first question, there are the reasons of filing when filing the change. I will send a list of reason of the filing later.
評価
50
翻訳 / 英語
- 2019/11/21 08:14:06に投稿されました
We submitted MF change of A product to PMDA and they are asking some questions regarding its contents. There are 5 of them all together from number 1 to number 5. "missing of corrected and added to JDMF" and "Actual change" in number 1 are 2 of those for the reasons for change items that was in the application. I will send you the list of reasons for the change later.
