5/4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。
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）
● 「What's New?」ウェブサイト
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4
http://www.ema.europa.eu/ema/
● 個々の通知類（品質関係以外の関連通知も含まれています）
Grouping of variations: questions and answers (updated)
Type-IA variations: questions and answers (updated)
Pre-authorisation guidance (updated)
Transfer of marketing authorisation: questions and answers (updated)
Classification of changes: questions and answers (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
Type-IA variations: questions and answers (updated)
Pre-authorisation guidance (updated)
Transfer of marketing authorisation: questions and answers (updated)
Classification of changes: questions and answers (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)
執筆者について
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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