EMA/審査関係の更新通知(2019年4月付)
※追記更新(2019.04.29)
4/11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。
4/11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(関連するもの全てを掲載しています)
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)
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)
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 procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
Extensions of marketing authorisations: questions and answers (updated)
Post-authorisation measures: questions and answers (updated)
Pre-authorisation guidance (updated)
Classification of changes: questions and answers (updated)
【4/29付追記更新】
4/29付けで、一部の更新追加があります。
関係者にあっては、「What's New?」ウェブサイト(下記URL)かあるいは個々のタイトルからリンク先をあたってください。
●What's New?」ウェブサイト
https://www.ema.europa.eu/en/news-events/whats-new
●個々の通知類(関連するもの全てを掲載しています)
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)
Risk management plan (RMP): questions and answers (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 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)
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 procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes) (updated)
Extensions of marketing authorisations: questions and answers (updated)
Post-authorisation measures: questions and answers (updated)
Pre-authorisation guidance (updated)
Classification of changes: questions and answers (updated)
【4/29付追記更新】
4/29付けで、一部の更新追加があります。
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
https://www.ema.europa.eu/en/
●個々の通知類(関連するもの全てを掲載しています)
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)
Risk management plan (RMP): questions and answers (updated)
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