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Archive for month: April, 2016


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. Read More

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