The Electronic Common Technical Document (eCTD) v4.0 Q&A v1.3 reaches Step 4 of the ICH Process

On 8 June 2020 the ICH announced that ICH eCTD v4.0 Q&A v1.3 document reached Step 4.

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.3 reached Step 4 of the ICH process in May 2020.

The eCTD v4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group (i.e. M8 IWG) on the eCTD v4.0 Implementation Package, and further to receiving new Change Requests in 2019, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.3.