The eCTD v4.0 Q&A v1.4 reaches Step 4 of the ICH process

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.

eCTD v4.0問答 v.1.4 達(dá)到ICH流程的第4步 

eCTD v4.0問答（Q&A）和規(guī)范變更請求文件v1.4于2020年12月達(dá)到ICH流程的第4步。

eCTDv4.0 Q&A文件是eCTD實(shí)施工作組（即M8 IWG）對eCTDv4.0文件實(shí)施包審查問題的總結(jié)，繼2020年收到新的變更請求之后，M8 EWG/IWG將eCTD v4.0 Q&A更新為1.4版。

eCTDv4.0 Q&A v1.4可在ICH ESTRI頁面上下載。