Module 12 Presentations

eCTD4.0

eCTD v.4

On ICH level agreement reached that eCTD 4.0 will be implemented

Advantages eCTD 4.0: • Possible to make one sequence for multiple registrations Need to have EU Repository for MRP/DCP and NP registrations → Not defined in the EU Roadmap • 2-way communication Applicant ↔ Agency Not to be implemented for now in EU. 2-way in EU would be 28-way

Disadvantage: • More complex, impossible to read “ human ”

The Organisationfor Professionals in Regulatory Affairs