Preparing Compliant eCTD Submissions In Asia

In May 2015, the US FDA published final and binding guidance requiring submission within 24 months of certain Common Technical Documents (CTDs) in an electronic format. This was ratified in 2017 and subsequently revised in February 2020 (Rev. 7).

Currently, other notifying bodies have followed suit (see table below), and while there are similarities in the CTD criteria, there are notable differences globally.