New version of the Guideline on eSubmissions for Veterinary Products

The new version of the Guideline on eSubmissions for Veterinary Products – version 2.4 together with eSubmission Validation checklist – version 2.4 and tools is published.The new VNeeS Guideline, checklist and checker will come into force on 01/07/2016.

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EU-EMA is transitioning to a compulsory usage of the eAFs

New versions of the electronic Application Forms (eAF v. 01.19.0.1) are now available. The version v. 01.19.0.1 of the eAFs can be used from 30 November 2015 and will replace the current version of eAF v. 01.18 after a transitional period on 11 January 2016.

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GCC Published final Module 1 Specifications Version 1.5

GCC Published final Module 1 Specifications Version 1.5. This document specifies Module 1 of the electronic Common Technical Document (eCTD) for Gulf Cooperation Council (GCC).

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Updated EU eCTD Module 1 Specification

To accommodate several change requests submitted since version 2.0 entered in to force in September 2013, a revision of the EU eCTD Module 1 Specification has taken place and the final version is now published (EU M1 v3.0 ).

This final approved version will enter into force on 1st July 2016 and will become mandatory on 1st October 2016. After October 1st, 2016 eCTD sequences built based on EU M1 specification version 2.0 will be rejected.

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Health Canada moving towards electronic submissions for DMF’s.

Health Canada is moving towards accepting all new DMFs only in non-eCTD electronic formats or eCTD formats effective immediately. For existing DMFs some conditions apply.

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Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software

FDA accepts PADER/PAER Submission in eCTD Format from June 10, 2015 onwards.

The Regulatory industry is witnessing huge transformations. Some new regulations see the light of the day as we grow in the world of automation for regulatory compliance. Intervention of information technology for submission of periodic reports in pharmacovigilance is yet another required transformation.

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Questions & Answers Blog on recent webinar on ‘Australia (AU-TGA) now recommends eCTD submission’

Q1. May I know the exact location of CRFs?

Ans. CRFs are located in in both Module 5-3-1-2 (comparative-ba-and-bioequivalence-study-report) or Module 5-3-7 (case-report-forms-and-individual-patients-listings)

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Switzerland (Swiss Medic) Module 1 Specification for eCTD Version 1.3

As per Swissmedic the new M1 eCTD Specification (v1.3) and validation criteria (v1.3) have been edited, expanded and updated. The M1 folder structure and file naming have been modified. With a view to future eGov portal developments, a number of validation criteria have been adjusted or added in v1.3.

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FDA to Approve ANDAs on the Basis of Draft

The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.

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Questions & Answers Blog on recent webinar on ‘Solution to Periodic Safety Submissions Reports (PADER/PAER) in eCTD’

These are few of the questions raised by Webinar audience regarding Periodic Safety Submissions Reports (PADER/PAER) in eCTD

Q 1. Is ICSR so called MedWatch Forms?

Ans. ICSRs are Individual case safety reports that carries information on adverse event(s) reported for drug and can be submitted in XML format. MedWatch is FDA Form 3500A, a reporting form for submission of suspected adverse events to USFDA i.e., it is a format that is accepted by US regulatory authority. For more information on ICSRs, please refer to ICH-E2B (R2) guidance – Data elements for transmission of Individual case safety reports.

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