ESG upgraded its Pre-Production WebTrader application

ESG upgraded its Pre-Production WebTrader application to 2.0 version, which is also known as Phase 2 release.

Upcoming ESG 2.0 – Phase 2 Release
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EU Module 1 eCTD Specification

The EU Module 1 eCTD Specification has been subsequently updated from version 3.0.1 to version 3.0.2 respectively.

The following aspects are addressed:
1. Due to an update of the EMA procedural guidance regarding documents displaying tracked changes in PDF format inside an eCTD sequence the following sentence was deleted:
“An exception to this rule is in the provision of either product labelling or risk management plan documentation in the Centralised Procedure, where the tracked changes version of the document in PDF format should be placed inside the eCTD, alongside the clean, non‐tracked version.”
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South Africa: MCC releases updated Module 1 eCTD specification and validation criteria

The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
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FDA’s Requirements for eCTD Submissions

eCTD is the standard format for submitting original applications, amendments, supplements, and registration changes to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
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FDA Delays eCTD Requirements for Master Files

As per guideline released on friday, FDA announces delay in submission of DMF in eCTD format until 5th may 2018
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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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