New FDA M1 Specifications include DDMAC, Bundled Submissions

As reported last month, the two significant changes to the specifications are is inclusion of DDMAC submission and bundled submissions. The largest change to FDA’s regional DTD is now one sequence can be submitted to multiple applications. This is a great feature if you create a single submission and replicate it to send to multiple applications. The only drawback to this plan is once you submit a bundled submission, the lifecycle for the document submitted cannot diverge in any of the applications.

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EMA to Release New Module 1 Specification (v1.4) in August

EMEA has announced that they will be releasing a new M1 eCTD specification in early August. EMEA will be releasing version 1.4, including a new DTD, implementation guide, transition guide, and validation guide.  According to Claire Holmes of EMEA, this new version will accommodate recent updates to guidance on variations. The new version will be recommended from January 2010, and mandatory from February 2010. Gary Gensinger of the FDA...

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Swissmedic Publishes M1 eCTD Specification, Validation Criteria

SwissMedic has issued a package of eCTD related specifications Swiss M1 Specification for eCTD Other Documents (DTD/MOD) Swiss eCTD Validation Criteria I have only done a cursory analysis as my day job is a bit overwhelming at the moment. The specification differs notably from the EMEA spec in several areas: SwissMedic has issued their own file and folder naming conventions for M1 as of course their M1 contents differ from EMEA Module...

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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...

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