EMA／Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cellsが採択
2021年7/31付（追記更新あり）GMP Platformトピック「EMA／Draft guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cellsのパブコメ開始」
10/26付でEMAからウェブサイト「Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells」
遺伝子組み換え細胞を含む高度なATMPsのコアSmPC（Su
関係者及び興味のある方は、下記URLsのウェブサイト、
l ウェブサイト「Guideline on core SmPC, labelling and package leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells」
https://www.ema.europa.eu/en/
l ガイドライン「Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells」
https://www.ema.europa.eu/en/
l パブコメ時ご意見「Overview of comments received on draft 'Guideline on core SmPC, Labelling and Package Leaflet for advanced therapy medicinal products (ATMPs) containing genetically modified cells' (EMA/CAT/CHMP/158266/2021)」
https://www.ema.europa.eu/en/
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