e-Dossier Submission: Regulatory and Procedural Guidance: Pepgra

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E-Dossier Submission Regulatory and Procedural
Guidance
An Academic presentation by Dr. Nancy Agens,
Head, Technical Operations, Pepgra
Group www.pepgra.com Email sales_at_pepgra.com
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Today's Discussion
OUTLINE OF TOPICS In Brief Introduction Fundament
als of Electronic Submission Consort Meta Data
Acceptance of E-Dossiers Conclusion
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In Brief

• This particular write-up presents a background
  about e- dossiers that are submitted to regional
  authorities by pharmaceutical companies for drug
  registrations. The write-up highlights the
  pre-requisites and procedures while submitting
  an e-dossier.

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Right from 1990, the International Conference for
Harmonization of Technical Requirements for
Pharmaceuticals for Human Use (ICH) has been
consistently striving to develop a framework
which is standardized with regards to drug
registrations.
The objective of such a standardized framework is
to bring about a harmony to the maximum extent
possible, the content and structure of the
technical information furnished to lend support
to marketing authorizations.
Introduction
The steering committee of the ICH during November
2000 had ratified guidelines which were
established by the ICH M4 working group,
elucidating the Common Technical Document (CTD)
in order to register pharmaceuticals that were
intended for use by humans (Bonn, 2007). The
focus here is to offer the capability to convey
the CTD from industry to a regulatory authority.
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Fundamentals of Electronic Submission
The specification for eCTD elucidates the format
for the message and the procedure for moving
submission documents and processing instructions
to an agency system. Standards as laid down by
the eCTD offers a medium to capture every
interaction that occurs between agencies and
industry, in such a way that it sheds light on
modifications between multiple
submissions. This lifecycle view of the
submission can be realized with the help of the
XML format. By using the XML format, it is
possible to describe every document that is
included within the submission.
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Meta Data
XML format offers instructions to the system that
receives the submission, thus enabling data
management, which elucidates the
submission. Such data is popularly known as meta
data and examples of meta data at the level of
submission comprises information pertaining to
the submission type, the agency that will receive
the submission and the applicants who submit
(FAMHP, 2016). These are frequently replace
document files that are unstructured with XML
documents that are highly structured and
exemplified by the FDAs Study Tagging File (STF)
or Europes electronic Application Form (eAF),
in tandem with initiatives at labeling like the
FDAs structured product labeling (SPL) and
EMEAs product information management (PIM).
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Acceptance of E-Dossiers
The NCA Medicines and Healthcare products
Regulatory agency (MHRA) in the UK has been
since 2005 accepting electronic submissions while
the paper format has been completely stopped
since 2007. As a matter of fact, MHRA has made
eCTD a mandatory requirement. While Belgium has
embraced eCTDs largely, they still accept other
formats. The same holds true for the
Netherlands, Norway, Germany, Sweden, France,
Denmark, Ireland and Austria.
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Conclusion
Application of the eCTD standard within the XML
format tends to allow an applicants submission
documents to be reused within diverse regional
markets. The submission is made up with five key
modules wherein the first module comprises of all
documentation specific to the region. Exchange
of this very initial module with a module
pertaining to another agency enables a highly
effective re-submission process across diverse
markets, without feeling the need to modify the
documentation or the meta data from the rest of
the four modules.
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