Module 12 2019

eCTD

eCTD v.3.2

eCTD exists for over 20 years as a standard, while the current version (3.2.2) is stable for the last 10 years.

• 2010: EMA implements eCTD only for CP

• 2019: Mandatory eCTD for all applications

• Transition from physical paper to electronic paper

The Organisation for Professionals in Regulatory Affairs