EMA/審査関係の更新通知(2021年2月付)
※追記更新(2021.02.17)
2/9付でEMAから審査関係の更新通知が発出されています。
これら通知類は「Regulatory and procedural guideline」などと合せて時折更新されます。
2/9付でEMAから審査関係の更新通知が発出されています。
これら通知類は「Regulatory and procedural guideline」などと合せて時折更新されます。
関係者にあっては、「What's New?」ウェブサイト(下記URL)
● 個々の通知類(審査関係のため安全性に関わるものも加えています)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
【2/17付追記更新】
2/16付のECA/GMP Newsが「EMA: Revised Q&A Document for Centralised Procedures」と題して関連記事を掲載しています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.org/gmp-news/ema-revised-q-a-document-for-centralised-procedures
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
【2/17付追記更新】
2/16付のECA/GMP Newsが「EMA: Revised Q&A Document for Centralised Procedures」と題して関連記事を掲載しています。
興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.
Changing the labelling and package leaflet (Article 61(3) notifications) (updated)
Frequently asked questions (updated)~COVID-19ワクチン関係です。
Type-IA variations: questions and answers (updated)]
Type-IB variations: questions and answers (updated)
Timetable: Type II variation and worksharing application assessment - ATMP (updated)
Timetable: Type IB variation requiring linguistic review (updated)
Timetable: Type II variation and worksharing application monthly assessment (updated)
Timetable: Type II variation and worksharing application weekly assessment (updated)
Timetable: Type II variation and worksharing application alternative monthly assessment (updated)
Frequently asked questions (updated)~COVID-19ワク
Type-IA variations: questions and answers (updated)]
Type-IB variations: questions and answers (updated)
Timetable: Type II variation and worksharing application assessment - ATMP (updated)
Timetable: Type IB variation requiring linguistic review (updated)
Timetable: Type II variation and worksharing application monthly assessment (updated)
Timetable: Type II variation and worksharing application weekly assessment (updated)
Timetable: Type II variation and worksharing application alternative monthly assessment (updated)
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