Future strategy for
e-submission
as seen by industry
Dr Michael Colmorgen, IFAH-Europe
2nd Veterinary Workshop on E-submission
4 Dec 2009, EMEA, London
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Future of e-submission
What is your feeling about e-submission approaching
your daily work?
2
Future of e-submission
IFAH Europe is supporting e-submission
• as it offers a lot of chances for an effective dossier
compilation and assessment process
• but for any future development constant care on the
constraints and impact on the animal health sector is
needed
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Future? What comes next on
short term?
First establish VNeeS …!
• 2010 will be a learning phase for both industry and
regulators and close cooperation is needed
• Establish appropriate document conventions or
check lists for successful e-submission
• Use suitable word-processing features to facilitate
PDF creation (this needs also to be considered for
regulatory templates like QRD templates)
• Gather experience how to handle lifecycle
procedures (variations, extensions, renewals… )
4
Future? What comes next on
short term?
And then …?
• It is advised to first implement the current projects
before moving to more complex systems like eNTA
5
eAF – The next step in 2010
Electronic application forms (eAF)
• Basically welcomed, IFAH-Europe involved since 2008
• Introduction of XML, allowing electronic exchange of
structured information
• Complex project due to interfacing, e.g. link with EU
TCT (EU Telematics Controlled terms)
• Benefit of this project is appreciated, like
easy user interface, pre-populating fields out of an
XML-file, dynamic forms or validation tools
• Chance for harmonisation especially in terms of
translation
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eNtA – The next specification?
eNTA
• Still early phase of development
• CONCEPT basically following eCTD
• Offering additional lifecycle support through XML
metadata
• May offer advantages mainly for assessors but
potentially also for industry - e.g. convenient views of
consolidated current dossier
• Simpler dossier structure and simpler specification
compared to eCTD
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eNtA – The next specification?
eNTA (continued)
BUT eNTA
• requires the use of a bespoke software
• may have limited advantage when implemented only
for new products if major scope is lifecycle –
consequences of retrospective application?
• use is restricted to Europe and size of the veterinary
dossier is not the same as for a human product
 less benefits than from eCTD!
8
eNtA – The next specification?
eNTA (continued)
• a key to success for this system is harmonisation and
two or three systems (VNeeS and paper) are not easy
to manage on a long term
• Option to completely remove paper submission?
(Legal basis to be created?)
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eNtA – The next specification?
eNTA (continued)
IFAH-Europe supports further activities on eNTA
project but strongly recommends to
• Define user requirements up-front to get a proper
understanding of the exact goals, both for industry
and authorities
• Do a thorough impact assessment before
implementation
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EU Central Repository
Web Portal / Central repository
• Clearly supported by IFAH-Europe
• Offers further chances for harmonisation, but …
only if it is used by all regulators (EMEA and NCAs)!
• Link to transparent process tracking systems?
• Single point of reference for the dossier
• Solves security issues with transport of CDs / DVDs
11
International Harmonization
Further harmonization of requirements
• Goal to use one system across all agencies in the EU
• But don’t forget about international Harmonisation…
• VICH?
At least common agreement about basic file standards
should be achievable across regions.
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Conclusions?
Don’t follow new paths without thorough reflection on
potential impact …
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Conclusions –
The future IS e-submission
IFAH-Europe is fully supporting e-submission projects
Some corner points need always be taken into
consideration:
1. Establish industry and regulators requirements first
2. Always establish clear benefits for industry and
regulators e.g. concerning increase of efficiency or
increase of transparency
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Conclusions –
The future IS e-submission
3. Careful impact assessment –
Consider also resources in the veterinary sector and
that there is often no specialized staff for publishing /
e-submission available
4. Don’t lose the goal of simple solutions - technology will
keep evolving but not everything that is doable in
terms of IT should be done
5. Developed standards need to be robust and sufficiently
stable over time
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Conclusions –
The future IS e-submission
6. A key for success is harmonisation. The development
of the 1-1-1 concept could bring a significant
advantage in this domain.
7. Last but not least - continue successful collaborative
industry / agency approach in TIGes veterinary
subgroup!
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Thank you for your attention!
Any further thoughts?
Questions?
Comments?
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