Dossier requirements for Centrally Authorised Products (CAPs)
Guidelines for submission and technical validation of applications
UC Effect Changes Design
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide
Centralised Procedure Process Timetable
New | IDMP version 2.0 has been published
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Secrets of eCTD Related Sequences
Closing the eCTD gap in one year
Australian regional specification – eCTD Version 3.1
Closing the eCTD gap in one year
eCTD Guidance v4 0-20160318-hv
OS000_00_004e_WL Guidance Industry eCTD
QA eCTD variations vers 6 Feb 2015_final
January 2015
Blog | LORENZ Life Sciences Group
Advance notice - update to an eCTD file download for version 3.1 | Therapeutic Goods Administration (TGA)
ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink
January 2015
eCTD Guidance v4 0-20160318-hv
Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences
Procedural announcements
TGA webinar: eCTD Module 1.3 - Best Practices
Closing the eCTD gap in one year
