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)
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.
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.
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 […]
The European Medicines Agency (EMA) and the European Commissions Directorate General for Health and Food Safety (DG SANTE) have agreed with the Swiss Agency for Therapeutic Products (Swissmedic) and the Swiss Federal Department of Home Affairs (FDHA) to share non-public information on the safety, quality and efficacy of medicines, already authorised or under review, both […]
South Africa (ZA-MCC) has a plan to start accepting dossier in eCTD format, From 1st June 2015 eCTD is open for entire industry. ZA-MCC released the eCTD Module 1 Specification, version 1.0 and Validation Criteria version 1.0