How Did We Get Here? A History of eCTD and Prospects for eCTD 4.0

The electronic Common Technical Document (eCTD) is 16 years old, approved by the International Council on Harmonisation (ICH) to Step 4 in 2008. It’s old enough to drive a car in the US. It’s had some small changes over the years but is still pretty much the same as it was in the George W. Bush era. It’s had a huge impact on the speed and accuracy of regulatory submissions for pharma … but it could be better. That same year, the US Food and Drug Administration (FDA) started looking at a next-generation submission format, which would become eCTD 4.0. That standard was approved to Step 4 at ICH in 2015, and nine years later, FDA is still not using it. Let’s look at how we got to this point, and what’s holding us back.