eCTD

1
eCTD

• An overview of the full day presentation by Dr
  Olaf Schoepke at the SAAPI conference in July 2008

2
Overview

• History
• Why go electronic?
• Types of electronic submissions
• What eCTD consists of
• Preparing eCTD
• Eye openers and bombshells
• Conclusion

3
eSubmissions history

• Began in late 80s but insufficient IT
  capabilities
• 1995 FDA used PDF files with hyperlinks
• 1997 CTD topic of ICH4
• 2001 first eCTD guideline
• 2003 CTD mandatory in EU and first eCTDs
  submitted
• 2006 lifecycle management a challenge

4
The future in EMEA

• July 2008 only electronic submissions accepted
  (either eCTD or non-eCTD)
• July 2009 strongly recommend only eCTD format
  electronic submissions to be accepted. Paper and
  other electronic formats to be exception.

5
Why go electronic?

• Quality
• Better quality
• Entire life cycle of product covered
• Easy and rapid call up of information
• Costs
• Paper and transportation costs reduced
• Storage and archive requirements reduced
• Faster, more efficient review, quicker
  registration
• Environmentally responsible

6
Save a tree!!

• NCE is approx 240,000 pages
• Paper for this would be 672 kg
• Equivalent to ONE average tree
• AN ENTIRE TREE IS REQUIRED TO SUBMIT A SINGLE
  COPY OF THE APPLICATION FORM ONE APPLICANT TO ONE
  HEALTH AUTHORITY

7
Types of electronic submissions

• NeeS format (Non eCTD electronic submission)
• Scanned version of paper submission without
  backbone etc.
• eCTD
• Documents in intelligent PDF, JPG or GIF
  format, with folder or tree structures and XML
  backbone

8
What does eCTD consist of?

• Folder or tree structure
• XML backbone file is Table of Contents
• Additional util information (Document type
  definition rule book for tags and attributes)
• Regional information and files

9
Folder Structure
Sections with specific information in folder
names
10
Preparing documents

• Templates should be used where possible
• Documents to be
• technically correct
• have the right granularity
• conform to external regulations/guidelines
• consistent with internal standards and styles
  naming conventions, etc.
• intelligent PDF files

11
From eCTD Fundamentals Dr O Schoepke
12
Granularity

• Defines how the completed document is broken
  down, tagged and stored for reuse
• Determines smallest piece of information that is
  reusable
• Changing granularity during lifecycle is
  difficult, therefore must be planned at the
  beginning.
• FDA Guidance
• Each document should be provided as a separate
  file

13
intelligent PDF files

• A file converted to special PDF format enabling
  links and bookmarks to be applied, and hence is
  searchable.

14
Cross referencing documents

• Intradocument links bookmarks
• Most intradocument links can be automatically set
  using templates
• To set each link manually would take MANY hours
• Interdocument links
• Cross reference documents in context of other
  documents.

15
Cross referencing submissions

• Inter submission links
• Cross references of submissions in context of
  other submissions, e.g. variations.

16
Time frames

• Once all documents are written, checked and
  formatted setting bookmarks and links take from 2
  to 12 weeks.

17
Eye openers

• Global application
• Life cycle history easily accessible
• Ease of compilation and review once system is up
  and running
• Intersubmission checks made possible by both
  applicant and reviewer
• Authenticity of documentation easy to verify.

18
Bombshells

• Extensive software programme needed to support
  the system
• Software programme used in EU costs 20,000 per
  USER (over R200,000 per user)
• Extensive IT support needed by applicant and
  regulator

19
Conclusion

• Great idea but need intermediate steps to get
  there
• CTD format to be adopted immediately
• NeeS in interim
• Essential to join electronic bandwagon