ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process

26th March 2025

ICH - The eCTD v4.0 Q&A v1.9 reaches Step 4 of the ICH process

The eCTD v4.0 Question and Answer (Q&A) and Specification Change Request Document v1.9 reached Step 4 of the ICH process in March 2025.

The eCTDv4.0 Q&A document is a summary of questions reviewed by the eCTD Implementation Working Group on the eCTDv4.0 Implementation Package, and further to receiving new Change Requests, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.9.

The eCTDv4.0 Q&A v1.9 is available for download on the ICH ESTRI page for eCTD v4.0 here.
 

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