EU and EMA eCTD Guidance
Electronic Common Technical Document (eCTD)
eCTD Module 1 Specifications
For eCTD submissions within the EU, the EU Module 1 eCTD Specification should be used.
eCTD Technical Validation
Before submitting an eCTD to EDQM, it should be technically validated using an appropriate checker/validation tool.
eCTD Technical Document
This question and answer document aims to address the commonly-asked questions and provide guidance.
eCTD Development and Maintenance
This document has been developed by the ICH M2 Expert Working Group and maintained by the eCTD.
eCTD Validity
The eCTD is valid for all European procedures: centralised procedure, decentralised, and mutual recognition.
eCTD Implementation Status and Lessons Learned
For EU experience in eCTD implementation, including current status, transition challenges, and lessons learned with eCTD adoption, refer to this document.
eCTD Software Validation
Go back to the validation software being used to revalidate the eCTD sequence and ensure it is up to date.
EMA Harmonized Technical Guidance
The European Medicines Agency (EMA) published version 5.0 of its Harmonized Technical Guidance for eCTD.
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