;   Medical Translation Insight: What happened to the "global" eCTD? - ForeignExchange Translations

What happened to the "global" eCTD?

What happened to the 'global' eCTD?Once upon a time, sponsors had to make regulatory submissions in multiple formats such as paper, eCTDs, and various hybrids. The advent of the electronic Common Technical Document (eCTD) promised to simplify and standardize all of these submissions.

Thanks to efforts by ICH, the United States, European Union, Japan, and Canada have adopted the eCTD specification [PDF link].

And indeed, submissions have become much simpler in these markets: "Ten years ago when sponsor’s looked to market their product globally, they would need to compile their applications individually according to each country’s specific format. Now, with CTD and eCTD, they’re minimizing the rework for at least 6-10 countries", notes the current issue of Applied Clinical Trials.

But the article goes on to say that while eCTD has made submissions easier across the ICH countries, many other countries are either ignoring the harmonized format or are putting in place new submission formats (Venezuela is a recent example of this).

Different regionally requirements represent another stumbling block. For instance, Study Tagging Files are required for a US eCTD, but not for an EU eCTD, and the files are not allowed in Japan.

So, what do pharmaceutical companies do about this? Shire, for one, seems to be fairly relaxed about it: "We've sent eCTDs to all the countries we have applications in and they are accepting them. From experience, we've learned that since there's not a standard or the standard is different in each country, we're finding if you push the envelope, they will take one standard."

Others are proactively pushing for regional harmonization, as Pfizer did at the recent MRCT conference in Korea.

So while significant progress has been made, the global eCTD standard is still a ways off.


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2 Comments:

  1. malli said...
    Excellent Post!

    Keep going.... next standard will be "RPS"

    Thanks
    Malli
    Antoinette Azevedo said...
    While we are "waiting" for RPS -- including ICH/FDA resolution of their differing requirements for eCTD NMV (next major version) -- please be aware that eCTD acceptance is growing with more countries accepting the format every month. EMEA is expected to announce their Electronic Submission Gateway this quarter to go live 1Q2010 which should eliminate the need for paper submissions. For the most part -- except for Module 1 as planned -- the eCTD requirements by the new countries are closely mapping to the EMEA requirements. A huge amount of the effort expended to produce the first country's submission can be saved when repurposing the dossier for the second and subsequent countries. The eCTD format is cheaper and faster to produce than paper and in general yields a faster agency review with higher quality assessment of the content.
    --Antoinette Azevedo, President & CEO, e-SubmissionsSolutions.com

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