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Managing the shift to eCTD

Managing the shift to eCTDWhile the electronic Common Technical Document (eCTD) is not yet a truly global standard, it is surely moving in that direction.

For sponsor organizations, the challenges in making the transition to electronic submissions lie in two areas, specifically: convincing upper management and implementing a "clean" eCTD process.

Support from upper management is vale to the success of the eCTD implementation. Gina Ross of Beckloff Associates recently suggested that the reason for this is because shifting the paper submissions to the eCTD will impact the entire organization and could cause an organization to rethink, perhaps, how they do business.

To help prepare for this dialog with management, Gina advocates organizing answers to the 5 "W" questions: Why? When? What? Where? How?

Once management support has been ensured, the focus shifts to implementing an eCTD process. Moving from paper to electronic submissions can take anywhere from three to six months. During this time, the main focus is on modifying document preparation processes, particularly in the following areas:

  • Organization of information. For instance, in the traditional format submissions are organized according to the Forms FDA 1571 for an IND and 356h for NDA, ANDA, and 505(b)(2). In contrast, the eCTD is organized according to the TOC Headings and Hierarchy guidance document.
  • Pagination. In traditional submissions, consecutive pagination is required within the volumes or across the entire submission. Not so with the eCTD. Pagination stats with each section.
  • Last-minute changes. In traditional submissions, late-stage changes or additions create rework and tremendous stress. In the eCTD format, last-minute changes are much easier to implement, thanks to file granularity.
  • Life cycle management. Within traditional formats, life cycle management is done at the submission level. Within the eCTD format, life cycle management also exists at the individual file level and is management through the use of operation attributes.

And it pays to focus on the details - regulatory agencies are demanding. FDA, for instance, is getting tougher with refuse-to-file letters.

As quoted in a presentation by Antoinette Azevedo of e-SubmissionsSolutions.com, FDA's top 12 issues for eCTD success are as follows:
   12. SPL must be in "SPL" folder
   11. Use elements and leaf titles correctly
   10. Always reference all files in the XML backbone(s)
   9. Include Module 1 in all eCTD submissions
   8. Make sure all application numbers are 6 digits
   7. Make sure all sequence numbers are 4 digits
   6. Do not use node extensions
   5. Verify that all MD5 checksums are correct
   4. All documents should conform to eCTD granularity
   3. All XML must use standard components
   2. Be sure all PDF hyperlinks & bookmarks are correct
   1. Include TOCs in all PDF documents

But pharmaceutical companies aren't the only ones struggling with the transition to eCTD. Many translation suppliers are asking more fundamental questions like: What is eCTD? Do I need to work in XML? Which modules require translation?

As more and more regulatory agencies encourage or mandate eCTD its use, eCTD adoption rate will continue to raise. Implementing an eCTD represents a major step for any sponsor organization though. Managing the shift as smoothly as possible requires management support, lots of interaction with regulatory authorities, and support from external suppliers.


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

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