Guidance for Industry
Providing Regulatory Submissions in Electronic Format - Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications...

eCTD Guidance Overview
eCTD Guidance and Specifications: eCTD Guidance Document, eCTD Specifications; eCTD Guidance: Changes from eNDA Guidance, Continuation of eNDA Guidance; Submissions 101 References...

eCTD ICH M2 EWG - Electronic Common Technical Document Specification
This specification has been developed by the ICH M2 Expert Working Group and maintained by the eCTD Implementation Working Group in accordance with the ICH Process as pertains to the M2 EWG and eCTD change control as it pertains to the eCTD IWG. ...

EMEA Implementation of electronic-only submission and eCTD submission
This question and answer document aims to address the commonly-asked questions and provide guidance regarding technical and practical aspects of the EMEA’s plans to implement electronic-only, and specifically eCTD-only, submission for the Centralised Procedure. ...

EMEA EMEA Implementation of Product Information Management (PIM)
in the centralised procedure
The electronic exchange of product information in structured format is a key strategic objective for EMEA in the area of information management. Over several years the EMEA has developed a set of tools and a defined approach to do this, ...