The eCTD v4.0 Q&A v1.4 Reaches Step 4 of the ICH Process

On 9 December 2020 the ICH Announced eCTD v4.0 Reaches Step 4.

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, as well as new Change Requests submitted in 2020, the M8 EWG/IWG has updated the eCTD v4.0 Q&A to version 1.4.

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