eCTD Requirements and cost effective solutions

 Electronic Common Technical Document -eCTD

eCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4, and 5  and customized administrative module 1 according to country-specific requirements.

Contents of  e-CTD

  • ICH recommended CTD  folder structure
  • XML backbone containing metadata such as document id, document  version, hyperlinks, file title, and leaf operation
  • Regional module  XML backbone, files, and folders (such as application form and cover letter) 
  • Documents in the word, pdf, xpt, or other agency recommended format
  • Checksum  values for documents and XML backbone
eCTD folder
The typical folder structure of eCTD Initial application

Why eCTD format?

Regulatory agencies are making the regulatory application in the eCTD format mandatory to eliminate the paper format.  eCTD helps agencies to track the application, search required information, maintain the life cycle of the application, and easy to review compared to paper applications.

Advantages of eCTD

  • Regulatory life cycle tracking at application and document level
  • Document integrity – Checksum is the fingerprint of the document. Change in the document generates the different checksum.
  • Easy to review – Agencies can easily search required information, and hyperlinking helps agencies to navigate to cross-linked information
  • Applicants can cross the link to the information provided in the previous submissions.
  • Helps applicants to easily  replace, append or delete documents which  reviewing agencies can easily track

How to prepare eCTD?

ICH (International Conference for Harmonization) has published harmonized eCTD specifications for module 2 to module 5. Module 1 specifications are established by country-specific agencies. There are several softwares available in the market for e CTD publishing. You can publish eCTD without software. However, it is too complex a task and requires XML editing knowledge.    Before publishing eCTD,  you may have to insert a bookmark, table of contents, hyperlinks, and prepare the PDF documents as per the regulatory agency standards. Links for agency-specific documents are provided below.

 US FDA specification for PDF files

EU requirements for  PDF   files (refer page # 10 of 60)

Some eCTD software vendors offer advanced features in their applications, such as optimizing PDF as per regulatory agency requirements and in-built hyperlinking tools.

In-house publishing vs. outsourcing?

In-house publishing involves other aspects apart from buying the software. You should consider the below factors before buying the software.

  1. Cost of the publishing software
  2. Annual maintenance cost
  3. If you have multiple users, you may have to maintain the server
  4. Training of in-house employees
  5. You may have to buy PDF plugins (in case of PDF optimization is not included in the software)
  6. Bookmarking and hyperlinking PDF

 

FDAbasics can assist your company in publishing, validating, and submitting regulatory applications in e-CTD format with the most competitive pricing. Contact us for more information.  

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