【摘要】：目前國際上有超過40個國家和地區(qū)已經(jīng)采用了e CTD標準,如美國、加拿大、歐盟及其成員國(包括英國)、瑞士、南非、日本等,藥品注冊文件遞交和審評已經(jīng)由紙質版過渡到了電子化。ICH M2 EWP(expert working group)指出采用軟件對電子提交的元數(shù)據(jù)和文檔結構,對電子提交文件的查閱、創(chuàng)建文件的生命周期管理和歸檔等方面做了規(guī)范。為了適應新藥研發(fā)的創(chuàng)新和國際信息化的飛躍發(fā)展,本文對CTD格式和e CTD格式申報資料模式的內容和流程進行了簡述和概括,并結合審評工作的體會,針對大多數(shù)國家已經(jīng)部分采納或者正在逐步轉向e CTD格式申報資料模式現(xiàn)象,分析我國目前實際情況,尤其是新藥審批若將e CTD申報模式引入,不僅保證注冊材料真實和完整,而且保證注冊申報環(huán)節(jié)規(guī)范和便捷,并且對e CTD格式申報資料模式優(yōu)勢進行了探討和展望。
[Abstract]:At present, more than 40 countries and regions in the world have adopted e CTD standards, such as the United States, Canada, the European Union and its member states (including the United Kingdom), Switzerland, South Africa, Japan, etc. The submission and review of drug registration documents has transitioned from a paper-based version to an electronic .ICH M2 EWP (expert working group), which indicates the use of software for electronic submission of metadata and document structures, and access to electronic submissions. Creation of file lifecycle management and archiving and other aspects of the specification. In order to adapt to the innovation of new drug research and development and the rapid development of international informatization, this paper briefly describes and generalizes the contents and processes of CTD format and e CTD format application data model, and combines with the experience of the review work. In view of the phenomenon that most countries have partially adopted or are gradually turning to the e CTD format declaration data model, this paper analyzes the current situation in China, especially if the e CTD declaration model is introduced into the new drug approval, it can not only guarantee the authenticity and integrity of the registration materials, Furthermore, the advantages of e CTD format are discussed and prospected.
【作者單位】： 上海藥品審評核查中心;國家食品藥品監(jiān)督管理局藥品審評中心;
【分類號】：R95

【相似文獻】

相關期刊論文 前10條

1 歐陽，

本文編號：2225213