EU eCTD Module 1 specification version 1.4.1 released
The final version 1.4.1 of the EU eCTD Module 1 specification have been released by EMA. The new version which has the version date "November 2011" incorporates the textual changes for further clarity that have been introduced already into the draft version 1.4.1 for consultation as released in August 2011 (see our related News Article - links at the bottom of this blog entry). However, the implementation of change requests that would necessarily lead to an update of the eu-regional.dtd have been postponed to the next major update of the DTD (see also the corresponding update of the EU Change Request Tracking table last week in our related News).
As mentioned above, the regional DTD and style sheets have not changed since version 1.4. They are however also provided as packaged .zip - file. As the technical files have not changed, no time frame for implementation by applicants has been communicated so far.
