Transcript eCTD - SAPRAA

eCTD
An overview of the full day presentation
by Dr Olaf Schoepke at the SAAPI
conference in July 2008
SAPRAA 5 Sept 2008
Overview
History
 Why go electronic?
 Types of electronic submissions
 What eCTD consists of
 Preparing eCTD
 Eye openers and bombshells
 Conclusion
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SAPRAA 5 Sept 2008
eSubmissions history
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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
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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.
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SAPRAA 5 Sept 2008
Why go electronic?
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Quality
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Costs
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Better quality
Entire life cycle of product covered
Easy and rapid call up of information
Paper and transportation costs reduced
Storage and archive requirements reduced
Faster, more efficient review, quicker registration
Environmentally responsible
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Save a tree!!
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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
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Types of electronic submissions
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NeeS format (Non eCTD electronic
submission)
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Scanned version of paper submission
without backbone etc.
eCTD
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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 structure
 XML backbone file is Table of Contents
 Additional ‘util’ information (Document
type definition – rule book for tags and
attributes)
 Regional information and files
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Folder Structure
Sections with specific
information in folder names
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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
SAPRAA 5 Sept 2008
D Fundamentals Dr O Schoepke
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Granularity
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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
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Each document should be provided as a separate
file
SAPRAA 5 Sept 2008
‘intelligent’ PDF files
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A file converted to special PDF format
enabling links and bookmarks to be
applied, and hence is searchable.
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Cross referencing documents
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Intradocument links – bookmarks
Most intradocument links can be
automatically set using templates
 To set each link manually would take MANY
hours
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Interdocument links
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Cross reference documents in context of
other documents.
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Cross referencing submissions
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Inter submission links
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Cross references of submissions in context
of other submissions, e.g. variations.
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Time frames
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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 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.
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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
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SAPRAA 5 Sept 2008
Conclusion
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Great idea but need intermediate steps
to get there
CTD format to be adopted immediately
 NeeS in interim
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Essential to join electronic bandwagon
SAPRAA 5 Sept 2008