The MCC of South Africa has released updated versions of Module 1 eCTD specification and validation criteria (version 2.0 and 2.1 respectively).
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).
As per guideline released on friday, FDA announces delay in submission of DMF in eCTD format until 5th may 2018
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.
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.
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).
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 […]
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.
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.
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)