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eCTD EU M1 v3.0 – A somewhat hasty implementation?

The EMA just released a new version 6.1 of the eCTD technical validation criteria, having corrected the MD5 checksums for two of the regional files. The good news is that the MD5 checksum did in fact exactly what it was supposed to do, i.e. protecting file integrity. Because of additions such as “EDQM” in eu-regional.xsl, eu-regional.dtd and eu-envelope.mod (eSubmission EU Module 1), the MD5 checksum changed. Although the checksum for eu-regional.dtd was altered in the eCTD validation criteria version 6.0, checksums for the other two seem to have been missed. This has now been corrected with version 6.1.

However, were these the only changes undertaken? Well, not quite. Comparing version 6.0 of the eCTD technical validation criteria with version 6.1 brings other inconsistencies to light, which leads me to believe that the changes have been undertaken in rather a hurry. The first thing that becomes obvious when opening eCTD Validation Criteria v6.0 is the versioning. Open version 6.1 (although named “v6.0”) and you are greeted with “EU Region eCTD Validation Criteria – Version 5.0 – March 2013”. Way off the actual version as stated further down on the same “Document change Control” sheet as part of the tracking table. This states the correct version 6.1, dated March 2016.

But something else is puzzling me. The tracking table in version 6.1 (again located in the “Document Change Control” tab) states that version 6.0 was released in “Jan-2016” whereas version 6.0 carries the “Feb-2016” date. Two different versions of the same document seem to have been used.

There are further indicators that the implementation of eCTD EU M1 3.0 has been done in haste. Adding “EDQM” was one of the upcoming enhancements in eCTD EU M1 3.0. This meant changes to the eu-regional.xsl stylesheet (eSubmission EU Module 1) where you already can find an entry for “EMA” as “code=’EU-EMA'”>EMA – European Medicines Agency”. It now also contains an entry for “EDQM” stating “code=’EU-EDQM'”>Spain – European Directorate for the Quality of Medicines & HealthCare”. It is my understanding that EDQM is based out of Strasbourg, France (if this entry is indeed required here), so why state “Spain”?

Although none of the above has a direct impact on the technical validation of eCTD submissions as such, it makes me wonder how the EMA internal processes are structured and quality controlled.


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