腾讯网

向4.0过渡，FDA 电子申报eCTD规范指南再修订

eCTD的注册申报源于ICH M2指南的发布，该指南规范统一了成员国必须遵守的药品注册文件的框架结构和格式。2003年，ICH发布了eCTD指导文件v3.0，后续进行了两次修订：2004年的v3.2和2008年的v3.2.2。2015年，ICH发布eCTD v4.0，根据ICH网站给出的区域实施信息，美国FDA 已于 ...
Yahoo Finance

FDA eCTD (Electronic Common Technical Document) Fundamentals and Process Submissions Course ...

Dublin, June 27, 2024 (GLOBE NEWSWIRE) -- The "eCTD Submissions - Fundamentals and Process" training has been added to ResearchAndMarkets.com's offering. eCTD Submissions, or electronic Common ...
Nature

The Common Technical Document: the changing face of the New Drug Application

Drug approval is the goal of the long process of drug development. Once preclinical and clinical trial data have been collected, a New Drug Application must be submitted to the regulatory authority ...