XML, eCTD & FDA - Electronic Information and Data Submissions


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Building functional documentation for the agency has changed from a submission often consisting of thousands of documents, boxed, placed in pallets and sent in trucks or via FedEx to the FDA. Paper submissions will soon be obsolete...it is SO last century!

FDA prefers a structured data format like the Extensible markup language (XML) as seen as follows:

Transition from paper to electronic submission (eSub) dossiers is done now via the electronic Common Technical Document (eCTD). XML is the backbone of an eCTD. So the writers compiling all this documentation need to beef up their skill set to meet up trends in technical documentation to ensure that the transmission of technical information to the agency is successful. Around ~10 yrs ago, 90% of business information captured in most biotech or big Pharma existed in the form of unstructured (non-data) content (SOPs, clinical reports, batch records, training materials, license applications, etc.). The paper method/system was used & favor b/c is cheap, easy & quick however, companies want to save time and money, need to be more efficient. The XML authoring was then adopted by corporations and recently, the regulators will require it worldwide. Wikipedia reference-linkXML

Extensible markup language (XML) is everywhere!
It is a computer language where structured information is used during the preparation of documentation and facilitates sharing of data & information. Write once and use many times!
XML advantages:
  • organizing data
  • versatile & easy to write
  • no tags to memorize, you create your own tags meaning that I can set up my own system of organizing data that it is still compatible
  • like HTML/XHTML
  • document standardization, profiling and growth
  • everyone uses the same template for documents
  • structured system for content creation, review and approval and enforce adherence to this system
More about the move into adopting XML in pharma/biotech world:

  1. (broken link removed)
  2. [ICH Guidance for Industry M2 eCTD] Electronic Common Technical Document Specification
It is recommended by some the use of XML authoring for any small or midsize biotech startup which is serious about quality control and particularly for those seeking ISO certification. XML authoring is gaining more acceptance and recommended by regulators b/c its use can reduce effort and improve quality of content if it is used in a customized software application's environment. The FDA provides (broken link removed) for the process of creating eCTD backbone files. International Conference on Harmonisation (ICH) and FDA specs must be met, & the process of having the eCTD tested for technical problems, and approved, by the FDA.

What a great advantage is to have a structured system for content creation, review and approval and enforce adherence to this system. This mindset is similar to the structured approach to business and document management that is reflected in the ISO Quality Management Systems. Just like ISO certification, utilizing of a structured document management system will assist in enhancing company's productivity and efficiency, and reduce errors - a goal that is shared by big Pharma/Biotech companies, big and small.

So...at this point...I'm just curious about how my colleagues are moving forward in migrating to this new standard. Are you still studying it, thinking about it? Are you convinced? Is cost an issue for you or training?
Is anybody already using the FDA's Electronic Submissions Gateway (ESG) for submitting/exchanging electronic information to the agency?

Thank you,
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Involved In Discussions
I am surprised there are no more contributions to this topic. I wonder if anyone can offer their 2 cents in the light of this notice issued by HC in May this year.

(broken link removed)

Effective immediately, the scope of the REP pilot has been expanded to include private labels. HPFB will be encouraging all medical device companies to take advantage of the opportunity to use the REP and submit their regulatory transactions via the Common Electronic Submissions Gateway (CESG). Transactions sent via the CESG are received by HPFB within minutes, using efficient and secure transmission in comparison to the current courier and email processes. Refer to the Common Electronic Submissions Gateway information page on the Health Canada website for further details.
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