Module 12 2019

eCTD structure

✓ There are two categories of modules: ▪ Regional module: 1 (different for each region; i.e., country) ▪ Common modules: 2–5 (common to all the regions) ✓ The common modules were developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG)

The Organisation for Professionals in Regulatory Affairs

Slide 22