Europe Medicines Agency

Country: European Union
Health Authority: European Medicines Agency (EMA)
eCTD, Accepted Since: 01-06-2005
eCTD Version: Module 1 Specification v3.0.4, M2-M5 – v3.2.2

Types of Applications

MA, Clinical Trial Application (CTA), Originals, Variations, Renewals, ASMF, CEP, PSUR with Centralized Procedure (CP), Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), National Procedure (NP)


  • Learn about the eCTD/Nees requirements
  • Review the eCTD/Nees submission guidance
  • Submit electronic Application Forms (eAF) and compliant PDFs
  • Request for submission number
  • Register for an eSubmission gateway and eSubmission web client
  • Submit via the eSubmission gateway and eSubmission web client


  • Requires cutting-edge technology and seasoned staff
  • Not all the content is in a standard format. Hence standardization is required
  • Difficult to implement last minute changes
  • Local affiliates have limited access to create or customize
  • Baseline submissions are costly and likely to be of limited value
  • Lifecycle management
  • Consolidated approach to drafting of dossier
  • How can Freyr help?

    • Guarantee your ROI with an eCTD software that optimizes cost-per-submission
    • Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
    • eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
      For more information on the same, consult us

    Other Countries

    USA, Health Canada, Switzerland, South Africa, Australia, EAEU, Jordan, Thailand, GCC, ASEAN