9 December 2020
The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.4 reached Step 4 of the ICH process in December 2020.
The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group (i.e. M8 IWG) on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests in 2020, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.4.
The eCTDv4.0 Q&A v1.4 is available for download on the ICH ESTRI page for eCTD v4.0 here.
eCTDv4.0 Q&A文件是eCTD实施工作组（即M8 IWG）对eCTDv4.0文件实施包审查问题的总结，继2020年收到新的变更请求之后，M8 EWG/IWG将eCTD v4.0 Q&A更新为1.4版。
eCTDv4.0 Q&A v1.4可在ICH ESTRI页面上下载。