GMP Platformでのレギュレーション情報として、下記のようなEMAの申請関係情報を過去にお伝えしております。
9/18付「EMA／申請関係ガイドライン等のアップデート」
9/23付「EMA／申請関係（post-authorisation ）のアップデート」
今般、11/6付でEMAから「一変に関するQ&Aとpre-nitification 」「pre-submissionのQ&A の更新」「pre-authorisation並びにpost-authorisation procedural advice の更新」などが多数発出されています。
また「efficacy」や「pharmacovigilance」に関するガイダンス等も“What's New?”として通知されています。
関係者にあっては、下記URLs（品質に係ると思われるものに限定しています）をご参照ください。
● Type-IB variations: questions and answers
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000085.jsp&mid=WC0b01ac058013af9c
● Regulatory and procedural guideline: Pre-notification check for type IB Variations
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2015/11/WC500196337.pdf
● Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500003981.pdf
● Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes（上記の改訂履歴付版）
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/12/WC500157547.pdf
● Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
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（上記の改訂履歴付版）
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/12/WC500158282.pdf
● Presubmission guidance: questions 34 to 44
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000023.jsp&mid=WC0b01ac0580022714
● Presubmission guidance: questions 45 to 56
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 57 to 67
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000028.jsp&mid=WC0b01ac0580022716#
9/18付「EMA／申請関係ガイドライン等のアップデート」
9/23付「EMA／申請関係（post-
今般、11/6付でEMAから「一変に関するQ&Aとpre-
また「efficacy」や「pharmacovigilanc
関係者にあっては、下記URLs（
● Type-IB variations: questions and answers
http://www.ema.europa.eu/ema/
● Regulatory and procedural guideline: Pre-notification check for type IB Variations
http://www.ema.europa.eu/docs/
● Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
http://www.ema.europa.eu/docs/
● Regulatory and procedural guideline: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes（上記の改訂履歴付版）
http://www.ema.europa.eu/docs/
● Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
http://www.ema.europa.eu/docs/
● Regulatory and procedural guideline: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with track changes（上記の改訂履歴付版）
http://www.ema.europa.eu/docs/
● Presubmission guidance: questions 34 to 44
http://www.ema.europa.eu/ema/
● Presubmission guidance: questions 45 to 56
http://www.ema.europa.eu/ema/
● Presubmission guidance: questions 57 to 67
http://www.ema.europa.eu/ema/
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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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