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e-Dossier Submission: Regulatory and Procedural Guidance: Pepgra

Regulatory experts need a strong understanding of the requirements, frameworks, skills and technologies required to submit compliant submissions from the Common Electronic Technical Document (eCTD). It starts with knowing what will and will not be approved. The change to electronic format has also made matters more complicated. When businesses move to the online standard Electronic Common Technical Document (eCTD) format, they are gradually uncovering some burdens. ECTDs which fail to meet technical validation requirements can result in rejection by health authorities. Health authorities are raising the bar for reliable, compliant eCTDs because of pressure to meet deadlines for the process. The FDA has ordered almost all submission forms to be delivered in eCTD format starting from 2017. As well, other regulatory agencies are shifting to mandate eCTD delivery. <br><br>Learn More: http://bit.ly/2UrwyGV<br><br>Need Help: <br>Uk: 44- 7424810299<br>Email: sales@pepgra.com<br>Whatsapp: 91 9884350006<br>

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e-Dossier Submission: Regulatory and Procedural Guidance: Pepgra

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  1. E-Dossier Submission: Regulatory andProcedural Guidance An Academic presentationby Dr. Nancy Agens, Head, Technical Operations, Pepgra Group: www.pepgra.com Email:sales@pepgra.com

  2. Today'sDiscussion OUTLINE OFTOPICS In Brief Introduction Fundamentals of Electronic Submission Consort MetaData Acceptance ofE-Dossiers Conclusion

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

  4. 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 drugregistrations. 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 marketingauthorizations. Introduction The steering committee of the ICHduring 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 regulatoryauthority.

  5. Fundamentals of ElectronicSubmission The specification for eCTDelucidates the format for the message and the procedurefor moving submission documents and processing instructions to an agencysystem. Standards as laid down by the eCTD offers a medium to capture every interaction thatoccurs between agencies and industry, in such a way that it sheds light on modifications between multiplesubmissions. This lifecycle view of the submission can be realized with the help of the XMLformat. By using the XML format, it is possible to describe every document that is included withinthe submission.

  6. MetaData XML format offers instructions to the system that receives the submission, thus enablingdata management, which elucidates thesubmission. Such data is popularly known as meta data and examples of meta data at the level ofsubmission 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 thatare 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).

  7. Acceptance ofE-Dossiers The NCA Medicines and Healthcare products Regulatory agency (MHRA) in the UKhas been since 2005 accepting electronic submissions while the paper format has been completely stopped since2007. As a matter of fact, MHRA has made eCTD a mandatory requirement. While Belgium has embraced eCTDs largely, they still accept otherformats. The same holds true for the Netherlands, Norway, Germany, Sweden, France,Denmark, Ireland andAustria.

  8. Conclusion Application of the eCTD standard within the XML format tends to allow anapplicant’s submission documents to be reused within diverse regionalmarkets. The submission is made up with five key modules wherein the first module comprises ofall documentation specific to theregion. Exchange of this very initial module with a module pertaining to another agency enablesa highly effective re-submission process across diverse markets, without feeling the needto modify the documentation or the meta data from the rest of the fourmodules.

  9. ContactUs UNITEDKINGDOM +44- 7424810299 INDIA +91-9884350006 EMAIL sales@pepgra.com

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