为适应信息时代的不断进步和新药研发的高效创新，目前美国FDA、欧盟EMEA 和日本厚生省等国外主流国家的药品注册文件递交和审评已经由纸质版走向了电子化。ICH M2 EWP（Expert Working Group）的eCTD 指导原则提出了制药商向评审机构进行电子提交的标准结构和格式，采用XML（eXtensible Markup Language）对元数据和文档结构进行描述，同时对电子提交物的创建、查阅、生命周期管理及归档等方面做了规范。为顺应时代潮流，中国也开始尝试使用eCTD 格式对化学新药的申请提出了这一要求。
天士力推进的第一个欧盟药品注册项目也采用了当下通行的eCTD 文档管理和电子递交（e-Submission）模式，成功通过欧洲电子通道CESP 向荷兰药监部门（CBG-MEB）进行了递交。通过这一项目的应用，结果表明eCTD 电子文档申报不仅能够保障申报信息规范、完整，而且通过这一标准化途径，也有利于实现信息交互与共享，提高注册效率，为欧盟后续评审过程跟踪提供支撑。eCTD 申报模式不仅能够保证注册申报环节规范、便捷，注册材料完整、标准，还能够提高审评效率，节约注册成本，是我国未来药品申报的趋势和方向。

In order to catch up with the development of information era and highly efficient innovation of new drug development, USFDA, EMEA, and JP PMDA have adopted e-submission and review of drug registration instead of paper documents. The specification of eCTD is developed by ICH M2 Expert Working Group (EWP), which provides the standardized structure and format of eCTD for its creation, review, lifecycle management, and archival of the e-submission. The XML (extensible markup language) backbone is used to provide a hyperlinked table of contents to the entire submission when viewed in web browser with a suitable style sheet and provide descriptive information ("meta-data") on the files that make up the actual content of the eCTD. Following the trend of e-submission, Chinese FDA has started trying to push e-submission in chemical drug application. Tasly has successfully submitted the first registration of herbal medicinal product to CBG-MEB with eCTD dossier via "Common European Submission Platform (CESP)". Tasly's practice on e-submission shows multiple advantages of eCTD, such as providing standard and complete registration information, implement information exchange, and information sharing, improving the efficiency of registration, and supporting the subsequent process tracking. The e-submission with eCTD files not only can ensure the standard and simple registration procedure and complete and standard registration files, but also can enhance the review efficiency and reduce the registration cost, which will be the trend for future drug registration in China as well.

国家十二五重大新药创制“中药欧盟注册项目”（2012ZX09101-231）