天士力推進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,而且通過這一標準化途徑,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、標準,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."/>

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首頁 > 過刊瀏覽>2014年第37卷第5期 >2014,37(5):401-403. DOI:10.7501/j.issn.1674-6376.2014.05.004
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歐盟藥品注冊申請中電子文檔遞交的應(yīng)用與實踐

Application and practice for e-submission of drug registration in EU

發(fā)布日期:2014-10-13
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