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医学类-ICH 文件更正(E1)

医学类-ICH 文件更正(E1)

作者: 译文达练 | 来源:发表于2024-04-17 09:46 被阅读0次
    1. ICH:曾用英文名 International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human use(“国际人用药品技术要求协调会” ),
      现为The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use,译为“人用药品技术要求国际理事会”

    2. non-life-threatening conditions:
      原译文:非危及生命性疾病
      自译文:非生命威胁性疾病(二者都行,看个人习惯吧)

    3. The guideline has been developed by the appropriate ICH Expert Working Group and has been subjected to consultation by the regulatory parties, in accordance with the ICH Process. At the Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
      原译文:该指导原则由相应的ICH 专家工作组制定,按照ICH 进
      程,已通过药品监管机构讨论。在ICH 进程第四阶段,最终
      草案被推荐给欧盟、日本和美国的管理机构采纳。
      自译文:
      本指导原则由相应的ICH专家工作组制定,并根据ICH进程提交给管理当局征询意见。在进程的第四阶段,终稿被推荐给欧盟、日本和美国的管理机构。

    4. The guideline has been developed by the appropriate ICH Expert Working Group and has been subjected to consultation by the regulatory parties, in accordance with the ICH Process. At the Step 4 of the Process the final draft is recommended for adoption to the regulatory bodies of the European Union, Japan and USA.
      原译文:ICH进程第二阶段公众讨论后被指导委员会批准
      自译文:指导委员会在第二阶段予以批准,并向公众发布征询意见。

    5. Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.
      原译文:ICH进程第四阶段被推荐给ICH三方管理机构后被采纳。
      自译文:指导委员会在第四阶段予以批准,并推荐给三个ICH管理机构。

    6. Current Step 4 Version
      原译文:目前第四阶段版本
      自译文:现行第四阶段版本

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