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SAPRAA 5 Sept 2008 eSubmissions history Began in late 80’s but insufficient IT capabilities 1995 FDA used PDF files with hyperlinks 1997 CTD topic of ICH first eCTD guideline 2003 CTD mandatory in EU and first eCTDs submitted 2006 lifecycle management a challenge
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SAPRAA 5 Sept 2008
eCTD
An overview of the full day presentation by Dr Olaf Schoepke at the SAAPI conference in July 2008
SAPRAA 5 Sept 2008
Overview
HistoryWhy go electronic?Types of electronic submissionsWhat eCTD consists ofPreparing eCTDEye openers and bombshellsConclusion
SAPRAA 5 Sept 2008
eSubmissions history
Began in late 80’s 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
SAPRAA 5 Sept 2008
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.
SAPRAA 5 Sept 2008
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
SAPRAA 5 Sept 2008
Save a tree!!
NCE is approx 240,000 pagesPaper for this would be 672 kgEquivalent to ONE average tree
AN ENTIRE TREE IS REQUIRED TO SUBMIT A SINGLE COPY OF THE APPLICATION FORM ONE APPLICANT TO ONE HEALTH AUTHORITY
SAPRAA 5 Sept 2008
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
SAPRAA 5 Sept 2008
What does eCTD consist of?
Folder or tree structureXML backbone file is Table of ContentsAdditional ‘util’ information (Document
type definition – rule book for tags and attributes)
Regional information and files
SAPRAA 5 Sept 2008
Folder Structure
Sections with specific information in folder names
SAPRAA 5 Sept 2008
Preparing documents
Templates should be used where possibleDocuments 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
SAPRAA 5 Sept 2008From eCTD Fundamentals Dr O Schoepke
SAPRAA 5 Sept 2008
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
SAPRAA 5 Sept 2008
‘intelligent’ PDF files
A file converted to special PDF format enabling links and bookmarks to be applied, and hence is searchable.
SAPRAA 5 Sept 2008
Cross referencing documents
Intradocument links – bookmarksMost intradocument links can be
automatically set using templatesTo set each link manually would take MANY
hoursInterdocument links
Cross reference documents in context of other documents.
SAPRAA 5 Sept 2008
Cross referencing submissions
Inter submission linksCross references of submissions in context
of other submissions, e.g. variations.
SAPRAA 5 Sept 2008
Time frames
Once all documents are written, checked and formatted setting bookmarks and links take from 2 to 12 weeks.
SAPRAA 5 Sept 2008
Eye openers
Global applicationLife cycle history easily accessibleEase of compilation and review once
system is up and runningIntersubmission checks made possible
by both applicant and reviewerAuthenticity of documentation easy to
verify.
SAPRAA 5 Sept 2008
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
SAPRAA 5 Sept 2008
Conclusion
Great idea but need intermediate steps to get thereCTD format to be adopted immediatelyNeeS in interim
Essential to join electronic bandwagon
