A public ICH meeting is planned for 14 November 2008 in Brussels, Belgium. See Brussels ICH Public Meeting, Nov. 14, 2008 for the details and agenda.
The agenda includes a session on standards development for the electronic exchange of information (chaired by Andrew Marr). That session will include, among other topics, an update on eCTD from Joe Cipollina.
Showing posts with label ICH. Show all posts
Showing posts with label ICH. Show all posts
Friday, October 10, 2008
Tuesday, September 16, 2008
ICH Publishes Updates to eCTD Specification
ICH has published a new eCTD specification (version 3.2.2) and STF specification (v2.6.1), as promised some time ago. This was done with little fanfare - the announcement and links to the documents can be seen at:
eCTD News
For those of you who monitor What's New on the ICH website? - the updates did not merit a mention there.
The changes resulted from a June meeting, the documents are dated July 2008 and were published on the ICH web site at the end of August.
Only the narrative portion of the document was changed. The DTD and stylesheet have remained unchanged. (In addition, the "valid-values.xml" file has been updated to change file tag "randomisations-scheme" to "randomisation-scheme").
Changes to the spec are mainly clarifications and items that have been tracked in the Q&A Document (updated version 1.15.1 has been posted), so there really shouldn't be anything alarming... For the STF document, the cumulative STF approach has been removed (as FDA does not allow it) and other minor updates made.
One nice thing is that the PDFs of these documents are properly bookmarked in Acrobat :-) !
eCTD News
For those of you who monitor What's New on the ICH website? - the updates did not merit a mention there.
The changes resulted from a June meeting, the documents are dated July 2008 and were published on the ICH web site at the end of August.
Only the narrative portion of the document was changed. The DTD and stylesheet have remained unchanged. (In addition, the "valid-values.xml" file has been updated to change file tag "randomisations-scheme" to "randomisation-scheme").
Changes to the spec are mainly clarifications and items that have been tracked in the Q&A Document (updated version 1.15.1 has been posted), so there really shouldn't be anything alarming... For the STF document, the cumulative STF approach has been removed (as FDA does not allow it) and other minor updates made.
One nice thing is that the PDFs of these documents are properly bookmarked in Acrobat :-) !
Tuesday, February 5, 2008
ICH M2 (ESTRI) EWG will not implement eCTD 3.3.3
At the October 2007 ICH Meeting of the ICH, 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.
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.
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