eCTD NEWS

From October 2007 ICH Meeting:

Testing of the eCTD Version 3.3.3 specification was completed. It was found to be technically acceptable, however, it was decided that at this time our focus must be on gathering the business requirements for the next major version of the eCTD. The decision was taken, therefore, 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.

Work will proceed, however, 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.