e-Dossier Submission Regulatory and Procedural Guidance Pepgra
                     E-Dossier Submission:  
Regulatory and 
Procedural  Guidance
An Academic presentation by
Dr. Nancy Agens, Head, Technical Operations, 
Pepgra  Group: www.pepgra.com
Email: [email protected]
Today's 
Discussion
OUTLINE OF TOPICS
In Brief  Acceptance of E-Dossiers
Introduction Conclusion
Fundamentals of Electronic Submission Consort 
 Meta Data
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.
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.
Introductio
n 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.
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.
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 FDA’s Study Tagging File (STF) or Europe’s  
electronic Application Form (eAF), in tandem with initiatives at labeling like the FDA’s  
structured product labeling (SPL) and EMEA’s product information management (PIM).
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.
Conclusio
n
Application of the eCTD standard within the XML format tends to allow an applicant’s 
 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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