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 ...
RAPS

FDA Unveils New Changes to eCTD Submission Formats

If you weren't paying attention closely late last week, you might easily have missed a small but important announcement made by the US Food and Drug Administration (FDA). By the end of 2014, it says, ...

1 Day Mastering Generic CTD Submissions in the MENA Training Course: Specific Documentation ...

Explore opportunities in mastering MENA's generic CTD submissions with expert-led insights. Harness regional expertise to streamline processes, minimize delays, and align with global strategies for ...
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 ...
RAPS

'Major Updates' to eCTD Module 1 Released by FDA

The US Food and Drug Administration (FDA) has announced the release of "major updates" to Module 1 of the electronic common technical documents (eCTD), used to supplement all eCTD submissions in the ...