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
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.
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