ICH Steering Committee (SC) has discussed about the status of work in relation to the development of the Next Major Version of the eCTD, Version 4.0. The SC noted that good progress had been made with the development of the ICH Implementation Guide for eCTD Version 4.0 and that the final version for testing was expected at the next meeting in Fukuoka in June 2012. The SC noted that a first round of Alpha Testing had already been carried out on the draft standard and ICH comments provided back to HL7 (Health Level Seven). The second round of Alpha Testing would be carried out following the Seville meeting and further ICH comments would be provided to HL7 in January 2012. The SC noted that based on the current timelines, Step 2 was expected by November 2013. The SC supported the work plan of the M8 EWG and endorsed v1.21 of the eCTD Change Request/Q&A document, which saw the incorporation of five new Q&As, and the removal of a previously added Q&A.
To find the ICH Steering Committee Discussion Summary document please use the below mentioned weblink
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