ICH M2 Working Group Shifts Focus to eCTD Version 4.0

At the October 2007 ICH Meeting, the decision was taken by the ICH M2 (ESTRI) EWG with approval from the ICH Steering Committee to stop the progression of the eCTD Version 3.3.3 Step 2 for Testing. The reason given was to focus on gathering the business requirements for the next major version of the eCTD. In general, the changes proposed in Version 3.3.3 were more beneficial to industry that to regulators. The agencies had concerns...

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