eCTD格式申报资料模式的探讨与展望
发布时间：2018-09-05 19:13
【摘要】：目前国际上有超过40个国家和地区已经采用了e CTD标准,如美国、加拿大、欧盟及其成员国(包括英国)、瑞士、南非、日本等,药品注册文件递交和审评已经由纸质版过渡到了电子化。ICH M2 EWP(expert working group)指出采用软件对电子提交的元数据和文档结构,对电子提交文件的查阅、创建文件的生命周期管理和归档等方面做了规范。为了适应新药研发的创新和国际信息化的飞跃发展,本文对CTD格式和e CTD格式申报资料模式的内容和流程进行了简述和概括,并结合审评工作的体会,针对大多数国家已经部分采纳或者正在逐步转向e CTD格式申报资料模式现象,分析我国目前实际情况,尤其是新药审批若将e CTD申报模式引入,不仅保证注册材料真实和完整,而且保证注册申报环节规范和便捷,并且对e CTD格式申报资料模式优势进行了探讨和展望。
[Abstract]:At present, more than 40 countries and regions in the world have adopted e CTD standards, such as the United States, Canada, the European Union and its member states (including the United Kingdom), Switzerland, South Africa, Japan, etc. The submission and review of drug registration documents has transitioned from a paper-based version to an electronic .ICH M2 EWP (expert working group), which indicates the use of software for electronic submission of metadata and document structures, and access to electronic submissions. Creation of file lifecycle management and archiving and other aspects of the specification. In order to adapt to the innovation of new drug research and development and the rapid development of international informatization, this paper briefly describes and generalizes the contents and processes of CTD format and e CTD format application data model, and combines with the experience of the review work. In view of the phenomenon that most countries have partially adopted or are gradually turning to the e CTD format declaration data model, this paper analyzes the current situation in China, especially if the e CTD declaration model is introduced into the new drug approval, it can not only guarantee the authenticity and integrity of the registration materials, Furthermore, the advantages of e CTD format are discussed and prospected.
【作者单位】： 上海药品审评核查中心;国家食品药品监督管理局药品审评中心;
【分类号】：R95
[Abstract]:At present, more than 40 countries and regions in the world have adopted e CTD standards, such as the United States, Canada, the European Union and its member states (including the United Kingdom), Switzerland, South Africa, Japan, etc. The submission and review of drug registration documents has transitioned from a paper-based version to an electronic .ICH M2 EWP (expert working group), which indicates the use of software for electronic submission of metadata and document structures, and access to electronic submissions. Creation of file lifecycle management and archiving and other aspects of the specification. In order to adapt to the innovation of new drug research and development and the rapid development of international informatization, this paper briefly describes and generalizes the contents and processes of CTD format and e CTD format application data model, and combines with the experience of the review work. In view of the phenomenon that most countries have partially adopted or are gradually turning to the e CTD format declaration data model, this paper analyzes the current situation in China, especially if the e CTD declaration model is introduced into the new drug approval, it can not only guarantee the authenticity and integrity of the registration materials, Furthermore, the advantages of e CTD format are discussed and prospected.
【作者单位】： 上海药品审评核查中心;国家食品药品监督管理局药品审评中心;
【分类号】：R95
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