EMA／申請関係ガイドライン等のアップデート(1/20付)

1/20付でEMAから申請関係の更新通知等が多数発出されています。

GMP Platformのウェブサイトに11/7付、9/23付並びに9/18付ニュース記事としてお伝えしているもの（下記参照）のアップデートに相当します。

12/5付「EMA／申請関係ガイドライン等のアップデート(12/4付)」
11/7付「EMA／申請関係ガイダンスとQ&Aのアップデート」
9/23付「EMA／申請関係（post-authorisation）のアップデート」
9/18付「EMA／申請関係ガイドライン等のアップデート」

関係者にあっては下記URLsをご参照ください。

● European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (updated)　【クリーン版】
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf
 
● European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes (updated)　【改訂履歴版】
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/12/WC500157547.pdf

● European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (updated)　【クリーン版】
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004069.pdf

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

● 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

● Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure (updated)　【クリーン版】
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/05/WC500186921.pdf

● Practical questions and answers to support the implementation of the variations guidelines in the centralised procedure: document with track changes (updated)　【改訂履歴版】
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/07/WC500146564.pdf

● Type-IA variations: questions and answers (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000019.jsp&mid=WC0b01ac0580023b12

● Electronic submission of Article 57(2) data: questions and answers (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/03/WC500123661.pdf

● Quality control of medicinal-product data submitted as per the legal requirement introduced by Article 57(2) of Regulation (EC) No. 726/2004 (updated)
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/11/WC500177533.pdf

● Reporting requirements for marketing-authorisation holders (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&mid=WC0b01ac058078fbe1

● Other post-authorisation activities: questions and answers (updated)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000052.jsp&mid=WC0b01ac0580168a6e