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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