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)

Process to be followed to make an EMA eCTD submission

  • 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

Challenges faced in making an EMA eCTD submission

  • 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