ICH M2 Working Group Shifts Focus to eCTD Version 4.0

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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 about the cost and effort of implementing the specification as it was largely focused on incorporating the STF into the eCTD backbone. FDA already considers that they have a satisfactory solution in the STF as it stands, and other regions have not identified any requirements for the STF. Japan in particular was said to be concerned about having to update newly completed procedures and tools to support 3.3.3 in the short term; however, a PMDA representive at the DIA Doc Management meeting expressed “strong support” for eCTD 4.0 during the February 7th International Regulatory Update session.

The M2 EWG also expressed a desire to improve the narrative portion of the specification and address those change requests that can be resolved without changes to the DTD. To the extent possible, existing Q&As will also be incorporated. This revised specification document will be issued as eCTD Version 3.2.1 during the coming months. Version 3.2.1 of the eCTD specification will be accompanied by an updated version of the Study Tagging File (STF) specification, version 2.6.1, which will address improvements to the narrative portion of this specification in the same way but will also not make any changes to the existing STF DTD.

See http://estri.ich.org/eCTD/news.htm for details.

Author: GS

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