為適應(yīng)信息時(shí)代的不斷進(jìn)步和新藥研發(fā)的高效創(chuàng)新，目前美國(guó)FDA、歐盟EMEA 和日本厚生省等國(guó)外主流國(guó)家的藥品注冊(cè)文件遞交和審評(píng)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(píng)審機(jī)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(duì)元數(shù)據(jù)和文檔結(jié)構(gòu)進(jìn)行描述，同時(shí)對(duì)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(shí)代潮流，中國(guó)也開始嘗試使用eCTD 格式對(duì)化學(xué)新藥的申請(qǐng)?zhí)岢隽诉@一要求。
天士力推進(jìn)的第一個(gè)歐盟藥品注冊(cè)項(xiàng)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(guò)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(guò)這一項(xiàng)目的應(yīng)用，結(jié)果表明eCTD 電子文檔申報(bào)不僅能夠保障申報(bào)信息規(guī)范、完整，而且通過(guò)這一標(biāo)準(zhǔn)化途徑，也有利于實(shí)現(xiàn)信息交互與共享，提高注冊(cè)效率，為歐盟后續(xù)評(píng)審過(guò)程跟蹤提供支撐。eCTD 申報(bào)模式不僅能夠保證注冊(cè)申報(bào)環(huán)節(jié)規(guī)范、便捷，注冊(cè)材料完整、標(biāo)準(zhǔn)，還能夠提高審評(píng)效率，節(jié)約注冊(cè)成本，是我國(guó)未來(lái)藥品申報(bào)的趨勢(shì)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(guó)家十二五重大新藥創(chuàng)制“中藥歐盟注冊(cè)項(xiàng)目”（2012ZX09101-231）