Module 12 2019

eCTD global

• EU ₋

Mandatory

• FDA ₋

Since 2008, eCTD has been the preferred format for electronic regulatory submissions to FDA ₋ May 2015, announcement of FDA for eCTD implementation ₋ May 2017, mandatory for NDA, ANDA, BLA ₋ May 2018, mandatory for IND

• Canada, Saudi Arabia, GCC, Switzerland, South Africa, Australia, Thailand…

The Organisation for Professionals in Regulatory Affairs

Slide 46