European Medicines Agency Guidance

The European Medicines Agency (EMA) mandates that all electronic submissions are in eCTD format. To navigate to useful eCTD-related guidance documents released by the EMA, select the links below.

EMA eCTD Guidance Documents

 

2016

A final version of the revised EU eCTD Module 1 Specification is now published. The final approved version will be accepted on July 1, 2016 and become mandatory on October 1, 2016.

EU M1 v3.0 eCTD Specification – Release Notes

EU M1 v3.0 eCTD Specification

EU M1 v3.0 eCTD Specification – Annexes

2015

Draft EU M1 v3.0 eCTD Specification for Public Comment (Clean)

Draft EU M1 v3.0 eCTD Specification for Public Comment (Annotated)

Draft EU M1 v3.0 eCTD Specification for Public Comment – Release Notes

2014

Dossier requirements for Centrally Authorised Products (CAPs) 

2013

EMA eSignature Capabilities: Frequently Asked Questions relating to the practical and technical aspects of the implementation

eCTD Validation Criteria Version 5.0

EU Module 1 Specification version 2.0

Best Archiving Practice Guidance

A Guide to the EMA file naming convention for eSubmissions

2010

Guidance for Industry on Providing Regulatory Information in Electronic Format – eCTD electronic submissions

Guidance for Industry on Providing Regulatory Information in Electronic Format – Non-eCTD electronic submissions (NeeS)

Practical guidance for the paper submission of regulatory information in support of a marketing authorization application when using the Electronic Common Technical Document (eCTD) or NeeS as the source submission