Module 12 2019

eCTD 4.0

eCTD v.4

The timeline for eCTD 4.0 has been further postponed, now proposing optional use of eCTD v.4.0 from Q3 of 2020 for CP submissions.

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 (or 27 after Brexit)

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

The Organisation for Professionals in Regulatory Affairs