※初出掲載（2021.12.14）
※追記更新（2021.12.16）
12/13付でEMAから「Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'」と題して、ICH M7のパブコメ時のご意見結果が公表されています。
と同時に、ウェブサイト「ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk」」が更新されています。
関係者および興味のある方は、下記URLsの更新ウェブサイトな
l パブコメ時ののご意見「 Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'」
https://www.ema.europa.eu/en/
l 12/13付Updated「ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk」
https://www.ema.europa.eu/en/
【12/16付追記更新】
12/15付でEMAが上記「ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk」および「Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'」の更新通知を発出しています。興味のある方は、下記UR
● 「ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk」
https://www.ema.europa.eu/en/
● 「Overview of comments received on 'Draft ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Addendum - Step 2b'」
https://www.ema.europa.eu/en/
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経歴 ※このプロフィールは掲載記事執筆時点での内容となります
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