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eCTD translation

Electronic submissions pose unique translation challengesThis recent call for help on the Wordfast mailing list caught my attention:

anybody got any experience with the medical translation branch of electronic Common Technical Document (eCTD)??

what are the formats used there (xml and pdf, I heard, but how do you manage to translate the xmls with wordfast??), how is the text (pharmaceutical-ish, or much more straight language, short sentences...??), any repetitions there?? any gloss (what would you recommend)????

any help appreciated...
The shift towards electronic submissions isn't easy - not for pharma companies, nor for translators. While pharmaceutical companies typically struggle with getting management support and managing timelines for the conversion to eCTD, many translators are dealing with more fundamental questions like: What is eCTD? Do I need to work in XML? Which modules require translation?

The technical specifications are defined in International Conference on Harmonization regional guidance documents. In addition, ICH eCTD Specification Version 3.2 provides the most detailed view of the requirements. FDA has individual specifications for Module 1 as well as Modules 2 through 5.

Wikipedia has a good overview of the organization of and content going into an eCTD. Content is generally defined by regional guidance documents. For instance, when submitting to FDA, the guidance document for Module 1 is Guidance for Industry, Submitting Marketing Applications According to the ICH CTD Format - General Considerations.

As even a cursory view of these document shows, eCTDs are large and complex. The best way to tackle them is through research. Here are some helpful resources:
  • The Lazlo Letter put together a good list of eCTD software packages.
  • When it comes to submissions in general and eCTD specifically, few people are as knowledgeable as Gina Ross. Her presentations on the subject are extremely insightful.
  • The eCTD Blog is a good all-around resource - check it out

ForeignExchange Translations provides specialized translation services for regulatory submissions by pharmaceutical and medical device companies. Contact us to learn more.


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