10/9付でEMAから先進医療（Advanced-therapy）に係る情報の更新通知が多数発出されています。
品質関係だけではありませんが、関連性もあるため、一連として列記しています。
関係者にあっては下記通知をご参照ください。
● Marketing-authorisation procedures for advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000388.jsp&mid=WC0b01ac05800862bc
● Legal framework
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000295.jsp&mid=WC0b01ac058007f4bb
● Guidelines relevant for advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000298.jsp&mid=WC0b01ac05800862bd
● Advanced-therapy classification
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000296.jsp&mid=WC0b01ac058007f4bc
● Summaries of scientific recommendations on classification of advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000301.jsp&mid=WC0b01ac05800862c0
● Advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp&mid=WC0b01ac05800241e0
● Pharmacovigilance for advanced therapies
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000297.jsp&mid=WC0b01ac05800862be
● Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000300.jsp&mid=WC0b01ac058095e6d5
● Advanced-therapy development and support to companies
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000641.jsp&mid=WC0b01ac058007f4bd
その他に、直接的には関係ありませんが、今後のミーティング予定も掲載されています。
● Meetings with stakeholders and other organisations
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000309.jsp&mid=WC0b01ac058009a23d
品質関係だけではありませんが、関連性もあるため、一連として列記しています。
関係者にあっては下記通知をご参照ください。
● Marketing-authorisation procedures for advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000388.jsp&mid=WC0b01ac05800862bc
● Legal framework
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000295.jsp&mid=WC0b01ac058007f4bb
● Guidelines relevant for advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000298.jsp&mid=WC0b01ac05800862bd
● Advanced-therapy classification
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000296.jsp&mid=WC0b01ac058007f4bc
● Summaries of scientific recommendations on classification of advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000301.jsp&mid=WC0b01ac05800862c0
● Advanced-therapy medicinal products
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000294.jsp&mid=WC0b01ac05800241e0
● Pharmacovigilance for advanced therapies
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000297.jsp&mid=WC0b01ac05800862be
● Certification procedures for micro-, small- and medium-sized enterprises (SMEs)
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000300.jsp&mid=WC0b01ac058095e6d5
● Advanced-therapy development and support to companies
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000641.jsp&mid=WC0b01ac058007f4bd
その他に、直接的には関係ありませんが、今後のミーティング予定も掲載されています。
● Meetings with stakeholders and other organisations
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000309.jsp&mid=WC0b01ac058009a23d
執筆者について
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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