🇯🇵 Current Nitrosamine Landscape in Japan?

[Yosukemino]

こんにちわ。

アンケート調査の取り扱いについて以下のスレッドが参考になったので、リンクを貼ります。ご確認よろしくお願いいたします。

IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022)

IPEC Europe announces the availability of the revised “Questionnaire for Excipient Nitrosamines Risk Evaluation” (Version 4, 2022) . First published in December 2019 and updated in 2021, the Questionnaire has proven useful to excipient producers and MAHs. This version is updated to remain contemporary with the EMA Q&A on Nitrosamines and clarifies that excipient manufacturers are not required to conduct a nitrosamine risk assessment without specific knowledge of the actual and specific drug pro…