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
- 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
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
References
