為適應(yīng)信息時代的不斷進(jìn)步和新藥研發(fā)的高效創(chuàng)新，目前美國FDA、歐盟EMEA 和日本厚生省等國外主流國家的藥品注冊文件遞交和審評已經(jīng)由紙質(zhì)版走向了電子化。ICH M2 EWP（Expert Working Group）的eCTD 指導(dǎo)原則提出了制藥商向評審機構(gòu)進(jìn)行電子提交的標(biāo)準(zhǔn)結(jié)構(gòu)和格式，采用XML（eXtensible Markup Language）對元數(shù)據(jù)和文檔結(jié)構(gòu)進(jìn)行描述，同時對電子提交物的創(chuàng)建、查閱、生命周期管理及歸檔等方面做了規(guī)范。為順應(yīng)時代潮流，中國也開始嘗試使用eCTD 格式對化學(xué)新藥的申請?zhí)岢隽诉@一要求。
天士力推進(jìn)的第一個歐盟藥品注冊項目也采用了當(dāng)下通行的eCTD 文檔管理和電子遞交（e-Submission）模式，成功通過歐洲電子通道CESP 向荷蘭藥監(jiān)部門（CBG-MEB）進(jìn)行了遞交。通過這一項目的應(yīng)用，結(jié)果表明eCTD 電子文檔申報不僅能夠保障申報信息規(guī)范、完整，而且通過這一標(biāo)準(zhǔn)化途徑，也有利于實現(xiàn)信息交互與共享，提高注冊效率，為歐盟后續(xù)評審過程跟蹤提供支撐。eCTD 申報模式不僅能夠保證注冊申報環(huán)節(jié)規(guī)范、便捷，注冊材料完整、標(biāo)準(zhǔn)，還能夠提高審評效率，節(jié)約注冊成本，是我國未來藥品申報的趨勢和方向。

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.

國家十二五重大新藥創(chuàng)制“中藥歐盟注冊項目”（2012ZX09101-231）