EMA／申請関係ガイドライン等のアップデート

9/17付でEMAから申請関係のガイドライン・ガイダンス等の更新通知がたくさん発出されています。
あまりにも多いのですが、それぞれの相関もあり、EMA担当官もまとめて通知しているように思われます。
関係者にあっては、EMAの下記最新通知ウェブサイトに掲載されている各ガイドライン等をご参照ください。

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/landing/whats_new.jsp&mid=WC0b01ac058004d5c4

なお、上記ウェブサイトに掲載されている9/17付通知を以下に列記します。

● Q&A 31-44: Similar biological product applications (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000129.jsp&mid=WC0b01ac0580533e0f

● Presubmission guidance: questions 45 to 56 (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000024.jsp&mid=WC0b01ac0580022715

● Presubmission guidance: questions 34 to 44 (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000023.jsp&mid=WC0b01ac0580022714

● Generic / hybrid applications: questions 23 to 34 (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000033.jsp&mid=WC0b01ac0580027091

● Presubmission guidance: questions 24 to 33 (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000020.jsp&mid=WC0b01ac0580022713

● Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004069.pdf

● Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/12/WC500158282.pdf

● Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications  (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500125166.pdf

● Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for similar biological medicinal product applications (track changes) (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2014/10/WC500176775.pdf

● Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004018.pdf

● Regulatory and procedural guideline: European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applications (track changes)  (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/03/WC500183994.pdf