※初出掲載 （2024.12.18）
※追記更新 （2025.01.28）
2023年12/17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）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（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 procedural advice for users of the centralised procedure for generic / hybrid applications
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
- European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)
- Type-IA variations: questions and answers
- Type-IB variations: questions and answers
- Type-II variations: questions and answers
- Worksharing: questions and answers
- Grouping of variations: questions and answers
- Extensions of marketing authorisations: questions and answers
- Transfer of marketing authorisation: questions and answers
- Questions and answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device
- European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
- European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications: document with track changes
- European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications
- Pre-authorisation guidance
- Biosimilar medicines: marketing authorisation
- EMA recommendation on the procedural aspects and dossier requirements for the consultation of the EMA by a notified body on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device - Revision 2
- Pre-submission request form for a EMA procedure prior to the submission of a marketing authorisation application or Article 58 Application
- EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
- Questions & answers - Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies
- Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics - Revision 1
【2025年1/28付追記更新】
2025年1/27付のECA/GMP Newsが「EMA: Q&A Documents for "Centralized Procedures" revised」と題して記事に取り上げています。
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-q-a-documents-for-centralized-procedures-revised
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