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BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)

Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE

Dossier requirements for Centrally Authorised Products (CAPs)
Dossier requirements for Centrally Authorised Products (CAPs)

Australian regional specification – eCTD Version 3.1
Australian regional specification – eCTD Version 3.1

January 2015
January 2015

Closing the eCTD gap in one year
Closing the eCTD gap in one year

Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE

Closing the eCTD gap in one year
Closing the eCTD gap in one year

Blog | LORENZ Life Sciences Group
Blog | LORENZ Life Sciences Group

Advance notice - update to an eCTD file download for version 3.1 |  Therapeutic Goods Administration (TGA)
Advance notice - update to an eCTD file download for version 3.1 | Therapeutic Goods Administration (TGA)

January 2015
January 2015

Closing the eCTD gap in one year
Closing the eCTD gap in one year

UC Effect Changes Design
UC Effect Changes Design

January 2015
January 2015

Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences

Blog | LORENZ Life Sciences Group
Blog | LORENZ Life Sciences Group

Centralised Procedure Process Timetable
Centralised Procedure Process Timetable

BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)

Closing the eCTD gap in one year
Closing the eCTD gap in one year

Post Authorisation Guidance-Integrated Version
Post Authorisation Guidance-Integrated Version

New | IDMP version 2.0 has been published
New | IDMP version 2.0 has been published

TGA webinar: eCTD Module 1.3 - Best Practices
TGA webinar: eCTD Module 1.3 - Best Practices

Product Management Services (PMS) - Implementation of International  Organization for Standardization (ISO) standards for the ide
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide

Procedural announcements
Procedural announcements

Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences

Guidelines for submission and technical validation of applications
Guidelines for submission and technical validation of applications

ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink
ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink