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Archive for category: eCTD


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


Is it time to turn your reporting structure ‘upside down’?

How familiar are you with the current issues around eCTD, that is Electronic Common Technical Document?  (If your primary interest is Europe, see here for more information:  and if your interest is in the US, see here)

If you are unsure about the term, which I admit isn’t that user-friendly perhaps, then the good news is it’s not that hard to unpack. All eCTD really means is a standards-based way the industry is going in to move from delivering drug marketing applications to regulatory authorities not in paper, but in an electronic format. The main drivers include a push by the ICH (International Conference on Harmonisation) process – which is to say US, Japan and Europe – which wants to use one common format: hence eCTD. (Please note this is for information on human drugs alone, although there is work going ahead in the veterinary field as well as in cosmetics.)

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