2/8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（関連するもの全てを掲載しています）
EMA launches checklist to facilitate validation for initial marketing authorisation applications ←新規です。
Dossier administrative validation checklist ←新規です。
EMA launches checklist to facilitate validation for initial marketing authorisation applications ←新規です。
Dossier administrative validation checklist ←新規です。
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (updated)
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes) (updated)
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 procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
Annual re-assessment: questions and answers (updated)
Generic and hybrid applications (updated)
Type-II variations: questions and answers (updated)
Renewal and annual re-assessment of marketing authorisation (updated)
Post-authorisation measures: questions and answers (updated)
Post-authorisation efficacy studies: questions and answers (updated)
Post-authorisation (updated)
Pre-submission queries service: questions and answers (updated)
Worksharing: questions and answers (updated)
Type-IB variations: questions and answers (updated)
European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes) (updated)
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 procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes (updated)
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
Annual re-assessment: questions and answers (updated)
Generic and hybrid applications (updated)
Type-II variations: questions and answers (updated)
Renewal and annual re-assessment of marketing authorisation (updated)
Post-authorisation measures: questions and answers (updated)
Post-authorisation efficacy studies: questions and answers (updated)
Post-authorisation (updated)
Pre-submission queries service: questions and answers (updated)
Worksharing: questions and answers (updated)
Type-IB variations: questions and answers (updated)
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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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