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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。
At present, there are over 40 countries and regions in the world that have adopted eCTD standards such as the United States, Canada, the European Union and its member states (including the United Kingdom), Switzerland, South Africa and Japan. The filing and review of the drug registration documents have been carried out on paper The transition to the electronic version. The ICH M2 EWP (expert working group) notes the use of software for the electronic submission of metadata and document structures, the review of electronic submission files, the lifecycle management and archiving of created documents. In order to adapt to the innovation of new drug research and development and the leapfrog development of international informatization, this paper briefly describes and summarizes the content and flow of the application mode of CTD format and e CTD format reporting data, combined with the experience of review work, Adopt or are gradually turning to the e CTD format declaration data pattern phenomenon and analyze the actual situation in our country at present. In particular, if new drug approval is introduced into the e CTD reporting mode, it not only ensures the authenticity and completeness of the registration materials but also ensures the registration and registration procedures are standardized and convenient e CTD format to declare the advantages of the data model were discussed and prospects.