9/22付でEMAから“臨床試験データの公表：Clinical Data Publication (CDP)”の実施についての外部ガイダンスが発出されています。
GCP関係・開発関係者の方及び興味のある方は、下記URLsの本ガイダンス並びに関連通知等をご参照ください。
●ガイダンス「External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (version 1.3)」のURL
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/09/WC500235371.pdf
●サマリー「Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’」のURL
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/09/WC500235370.pdf
●更新Q&A「Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP) 」のURL
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/04/WC500225881.pdf
●更新ウェブサイト「External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use」のURL
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001799.jsp&mid=WC0b01ac0580b2f6ba
GCP関係・開発関係者の方及び興味のある方は、下記URLsの
●ガイダンス「External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use (version 1.3)」のURL
http://www.ema.europa.eu/docs/
●サマリー「Summary of changes to the ‘External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use’」のURL
http://www.ema.europa.eu/docs/
●更新Q&A「Questions and answers (Q&As) on the external guidance of Policy 0070 on clinical data publication (CDP) 」のURL
http://www.ema.europa.eu/docs/
●更新ウェブサイト「External guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use」のURL
http://www.ema.europa.eu/ema/
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