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The electronic Common Technical Document is the (highly recommended) way to submit the information needed for marketing authorization from the regulatory authorities (FDA, EMEA, NIHS (Japan)). The eCTD essentially consists of an XML file (index.xml), a file structure, and a (rather large) number of PDF files (but also some other XML files). The XML file (the backbone) describes the file structure (so the location of all other files), checksums for these files (to guarantee integrity of the files) and meta-information about the files (version, operation status, role, keywords ...)
Module 1 of the eCTD (regional information) further contains 3 additional XML files (for each region one). These contain meta-information (e.g. applicant, product, submission date ...), and links to the files with the actual submission information.
This is a question often asked by RA departments within pharma companies.
Software providers, will answer you that their products will generate 90% of the necessary
XML for you and thus you do not need any XML knowledge. Well, they are right for 90%, if you do not intend to
do any life cycle management after the submission, and if your RA department is an island within your company.
The reason for our statement is that more and more, RA departments will receive their information, not as unflexible
PDF files, but as flexible and reusable XML data. A first example of this is CDISC,
the new standard for exchange of clinical data.
Secondly, most commercial tools (until now) do not allow you to do life cycle management on the eCTD. If, after
submission, your information has to be updated, this must be visible in the eCTD, and you will have to report the
updated information (with meta-information !) to the authorities. This requires you to update the eCTD XML, which
is not yet possible with the commercial tools. So you will have to know how to work with an XML editor.
The Document Type Definition (DTD) defines all the rules to which your eCTD XML document has to be comply.
So, in the "util/dtd" section of an eCTD submission template, you will find all the DTDs of your XML documents.
If e.g. your index.xml document does not comply to the DTD, most browsers, and most commercial eCTD tools, will
fail to open the document ! At that time, you will be glad you have XML knowledge in house, so that you can correct the error
in the XML file.
In many pharma companies however, people have difficulties in understanding the DTD, i.e. in understanding the
rules to which the XML files have to comply (reading a DTD is not easy). To help them, we have developed a
table,
which "translates" the DTD into a much better readable form. For the index.xml file in the main directory,
this table is 25 pages long, so
we publish an extract of it here.
The full table can be obtained free of charge,
simply by sending an e-mail to us.
Equivalent tables for the other DTDs in the eCTD can be obtained on request.
We organize special XML courses for pharmaceutical companies. On request, such a course can fully concentrate on the eCTD, so that after the (one-day, on location) course, your coworkers know everything about how to work with XML in the eCTD. For further details about conditions, costs, etc.. have a look at the courses web page.
