【英文】E11A:儿科外推(草案)

本文档为ICH《E11A:儿科外推》指导原则草案,旨在为使用儿科外推提供建议并促进国际协调,以支持儿科药物的研发和许可。

文书类别:药品/文件依据/征求意见稿 文书页数:44页 更新时间:2022-04-26

应用地区:全国 应用岗位:儿科外推 法规依据:无

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INTERNATIONAL COUNCIL FOR HARMONI SATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONI SED GUIDELINE P EDIATRIC E XTRAPOLATION E11 A Draft version Endorsed on 4 April 2022 Currently under public consultation At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to national or regional procedures.

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