E-Dossier Submission: Regulatory and Procedural Guidance

An Academic presentation byDr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.comEmail: sales@pepgra.com

OUTLINE OF TOPICS

In Brief

Introduction

Fundamentals of Electronic Submission Consort

Meta Data

Today's Discussion

Acceptance of E-Dossiers

Conclusion

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.

Introduction

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.

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.

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).

Meta Data

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.

Conclusion

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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