TGA webinar: eCTD Module 1.3 - Best Practices
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
Guidelines for submission and technical validation of applications
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide
January 2015
QA eCTD variations vers 6 Feb 2015_final
Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences
OS000_00_004e_WL Guidance Industry eCTD
eCTD EAEU
UC Effect Changes Design
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
January 2015
Closing the eCTD gap in one year
Procedural announcements
Centralised Procedure Process Timetable
eCTD Guidance v4 0-20160318-hv
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
Post Authorisation Guidance-Integrated Version
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Australian regional specification – eCTD Version 3.1
