12/4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）
● 個々の通知類
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)
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)
Pre-authorisation guidance (updated)
Type-II variations: questions and answers (updated)
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure - track changes (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)
Pre-authorisation guidance (updated)
Type-II variations: questions and answers (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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